A Clinically

Proven
Appetite
Suppressant

© Copyright 2008 by Gencor Nutrients, Inc.

GENCOR NUTRIENTS, INC.

Formerly Gencor Pacific, Inc.

920 E. Orangethorpe Avenue

Suite B, Anaheim, CA 92801
Telephone: 714.870.8723
Facsimile: 732.875.0306
info@gencorpacific.com www.slimaluma.com
 A New Appetite Suppressant Ingredient

SAFETY REVIEW

By Dr. Harry Preuss

Georgetown University Medical Center

Washington, D.C., USA

© Copyright by Gencor Pacific, Inc. 2004

Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss

Harry G. Preuss M.D., M.A.C.N., C.N.S.

Professor of Physiology, Medicine and Pathology
Georgetown University Medical Center
Washington, D.C. 20057
Source of Information

Much backgound material on Caralluma fimbiata was supplied by Gencor Pacific

Company. This information proved useful, especially their safety reports on Caralluma
fimbriata. Additional information was obtained from PubMed and off the internet from
Google.
Description
Caralluma fimbriata, also known as Caralluma ascendens, belongs to the family
ASCLEPIADACEAE. In western India it is also called Ranshabar, Makad shenguli,
Kallimudayan, and Shindala makadi (1). There are other species of Caralluma that grow
in India. Among these are: C. indica, C. attenuata, C. umbellata, and C. stalagmifera. All
these varieties of Caralluma are botanically and phytochemically similar to C. fimbriata
and regularly consumed by the native population across India (1).
Background of Caralluma Species
Caralluma fimbriata is a tender succulent that is found in the wilds of Africa, the Canary
Islands, Arabia, southern Europe, Ceylon, and Afghanistan (2,3). The Caralluma genus of
cacti is included among those listed as edible, because the daily diets of numerous natives
of India over many centuries include this edible, wild, succulent cacti (1,4,5). Daily
consumption is largely due to the fact that the Caralluma genus grows ubiquitously in that
area. Caralluma fimbriata is the most prevalent of the genus, as it grows wild in urban
centers, is planted as a roadside shrub, and is commonly used as a boundary-marker in
gardens. This so-called vegetable is eaten daily in several different forms – cooked as a
regular vegetable, placed in preserve like chutneys and pickles, and sometimes eaten raw.
To give specific examples, (1) Carullama fimbriata is consumed daily as a vegetable in the
Kolli Hills of South India; (2) it is used in pickles and chutney in the arid regions of
Andhra Pradesh; and (3) in Western India, Caralluma fimbriata is accepted as

1
Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss

a famine food – suppressing appetite and quenching thirst. Legend has it that hunting
tribes chewed chunks of the Caralluma cactus to suppress hunger and thirst when on a long
hunt. Most importantly to determine safety, there are no adverse event reports on the
Indian subcontinent over the centuries of use (1). Caralluma fimbriata is listed as a
vegetable in The Wealth of India, the Indian Health Ministry’s comprehensive compilation
on medicinal plants (2). Key phytochemical ingredients include pregnane glycosides (6,7),
flavone glycosides (8), megastigmane glycosides (8), bitter principles, saponins, various
flavonoids (9), etc.
Proposed Mechanisms of Action for Weight Reduction and Safety
It is postulated that the pregnane glycosides and perhaps other constituents in Caralluma
fimbriata prevent fat accumulation via blocking citrate lyase. This would be similar to the
mechanisms proposed for another product from India, Garcinia cambogia (10). This is
important for two reasons. The mechanism of action of Garcinia cambogia has proven to
be safe for those desiring to lose weight (11). In addition, clues as to how Caralluma
fimbriata works to reduce weight may emanate from our knowledge of Garcinia
cambogia. The active component in Garcinia cambogia is hydroxycitrate (HCA) (10), and
HCA has been reported to cause weight loss in humans without stimulating the central
nervous system [12]. Because it is a competitive inhibitor of ATP-citrate lyase, an extra-
mitochondrial enzyme involved in the initial steps of de novo lipogenesis (10).
Consequently, HCA reduces the transformation of citrate into acetyl coenzyme A, a step
necessary for the formation of fatty acids in the liver. In addition to its effect of citrate
lyase, the postulated blocking of malonyl Coenzyme A by Caralluma fimbriata could
further lead to a decrease in fat formation in the metabolic pathway. Again similar to
Garcinia cambogia (10), Caralluma fimbriata is reported to suppress appetite
hypothesized to be secondary to effects on the appetite control center of the brain. HCA
has been demonstrated to reduce food intake in animals suggesting its role in the treatment
of obesity and has been demonstrated to increase the availability of serotonin in isolated rat
brain cortex that could affect satiety [13-18]. More specifically, it is believed that the
pregnane glycosides in Caralluma fimbriata inhibit the hunger sensory mechanisms of the
hypothalamus.

2
Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss

In addition to the long history of safe ingestion of the cactus as a food, further
evidence of safety of its extract is evident through an acute oral toxicity study on rats and
two clinical studies. The former was carried out by the Department of Pharmacology, St
John’s Medical College in Bangalore, India. Doses of 2g/kg body weight and 5g/kg body
weight were gavaged to rats. All animals survived until the scheduled necropsy at the end
of the study period of 14 days. Histology revealed no abnormalities in the various organs.
Accordingly the LD50 for the rats exceeded 5g/kg.

Clinical Studies on Weight Reduction

Clinical Trial #1
An extract prepared via an aqueous alcohol extract and containing one gram of material
was developed and used in the weight loss studies. The extract dosage was based upon an
attempt to duplicate the average intake of 100 grams of raw cactus a day (10-12 grams
solid material). The first study performed in India consisted of 50 overweight/obese
subjects (BMI >26) –- 25 received active compound and 25 received a placebo. The study,
under the purview of the Institutional Ethics Review Board of St John’s National Academy
of Health Sciences, Banglore, India, was randomized, double-blind, and placebo-
controlled. Over eight weeks, the subjects were tested for weight-loss, anthropometry,
body fat composition, BMI, net weight and systemic functions. During the study, no
changes were made in diet; and all subjects were advised to walk 30 minutes in the
morning and evening. The adverse events were minor and limited to mild upset of the
gastrointestinal tract. Importantly, they were present equally in the active and placebo
groups. Constipation and flatulence subsided within a week and were attributed to the
gelatin capsules more than the ingredients from the cactus present in the capsules.
Examination of fasting and post-prandial sugar, total cholesterol, LDL, HDL, triglycerides,
serum creatinine, BUN, total protein, serum albumin, total bilirubin, conjugated bilirubin,
AST and ALT, and alkaline phosphatase, gamma GT, and hemoglobin failed to reveal any
overall toxicity from the extract (see Table 1). Blood pressure and EKG also showed no
toxic reactions secondary to ingesting Caralluma fimbriata.

3
Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss

Clinical Trial #2
The second study performed in California at the Western Geriatric Research Institute
consisted of 26 overweight patients, 19 on active compound and 7 on placebo. Over 60%
of those taking the extract lost 6 pounds or more for the month. This study is suggestive of
a positive effect of the Caralluma fimbriata extract on weight loss. Importantly, it
reaffirmed the safety of the extract, as no serious adverse events occurred.

Other Actions of Caralluma

In folklore medicine, plants of the Caralluma species have been used to treat diabetes. In a
study using streptozotocin diabetic mice, acute or subacute treatment with C. arabica
caused a statistically significant lowering of circulating blood glucose levels (19).
Streptozotocin-induced diabetes is a model for Type I diabetes mellitus. Accordingly, in
these insulin deficient mice, the Caralluma species was able to lower blood glucose
suggesting an “insulin-like” action, an increase in insulin release, and/or an ability to
sensitize the animal to lesser amounts of insulin. However, one oddity was that in this
particular study the glucose tolerance to a glucose challenge appeared better in the control
animals even though baseline sugars were higher in control.1 Similar to C. arabica,
extracts from C. attenuata were found to be antihyperglycemic in alloxan-diabetic rats
(20). Animal studies suggest that C. arabica extract is anti-nociceptive and anti-
inflammatory (21,22). Using the hot plate and writhing methods in albino mice and the
tail-flick method in Wistar rats, the nociceptive properties of C. arabica were shown. This
occurred when the extract was placed on the skin indicating transdermal absorption. The
lesser accumulation of edema in the in paws injected with carageenan indicated anti-
inflammatory properties as well. This property was localized to a specific pregnane
glycoside from C. umbellate (23). C arabica also has been shown to possess anti-gastric
ulcer and cytoprotective properties against damage produced by phenybutazone,
indomethacin, ethanol, sodium hydroxide, and/or cold restraint stress (24). The protective

1
This finding relates to therapeutic evaluation and is contrary to the other report mentioned above indicating
a hypoglycemic effect predominates. Accordingly, it would not appear to influence the safety of the
compound,

4
Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss

effect was postulated to be via multi mechanisms, including increased gastric production of
prostaglandins and mucin and reduced gastric acidity.

Overall View of Caralluma fimbriata and Extract

I have reviewed the Gencor Pacific report on Caralluma and believe the information is
correct and accurate. Accordingly, all current evidence points to the safety of Caralluma
fimbriata extract at the recommended doses.

I believe that Caralluma fimbriata is safe to consume at recommended doses based

on the following:
1. the cactus has been in the food chain of India for years and has not been
associated with any significant adverse side effects.
2. Caralluma fimbriata is listed in the Wealth of India as a famine food and by
various individuals on the internet as a safe-to-consume food
3. various testimonial by doctors and scientists confirm to its safety.
4. testimonial by individuals who regularly consume the product describe its
safety
5. the daily dose of the extract contains the same concentration of ingredients
as commonly eaten daily in the raw vegetable
6. a study to determine LD50 did not disclose toxicity, and it was reported that
the LD50 exceeded 5g/kg
7. two clinical studies composed of 44 individuals consuming the extract
failed to reveal any significant adverse events.
Bibliography
1. Report of KS Laddha, Medicinal Natural Products Research Laboratory, University
of Mumbai, Matunga, Mumbai, India.
2. Wealth of India. A Dictionary of Indian Raw Materials and Industrial Products
3:266-267, 1992.
3. http://www.botany.com/caralluma.html

5
Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss

4.http://www.hort.purdue.edu/newcrop/FamineFoods/ff_families/ASCLEPIADACEA
E.Html.
5.http://www.hort.purdue.edu/newcrop/faminefoods/ff_families/ASCLEPIADACEAE.
html
6. Hayashi K, Iida I, Nakao Yu, Nakao Yo, Kaneko K: Four pregnane glycosides,
boucerosides, AI, AII, BI, and BII from boucerosia aucheriana. Phytochemistry
27:3919-3924, 1988.
7. Abdel-Sattar E, Meselhy MR, Al-Yahya MAA: New oxypregnane glycosides from
Caralluma penicillata. Planta Med 68:430-434, 2002.
8. Bader A, Braca A, De Tommasi N, Morelli I: Further constituents from Caralluma
negevensis. Phytochemistry 62:1277-1281, 2003
9. Kamil M, Fjayaraj A, Ahmad F, Gunasekhar C, Samuel S, Chan K, Habibullah M:
Identification and quantification of flavonoids from Caralluma arabica and its
quality control studies. J Pharm Pharmacol 51(Suppl):225, 1999.
10. Preuss HG, Bagchi D, Bagchi, M, Rao CVS, Dey DK , Das S , Satyanarayana S:
Weight management and mechanisms of action of a novel, natural extract of (-)-
hydroxycitric acid (HCA-SX) and a combination of HCA-SX plus niacin-bound
chromium and Gymnema sylvestre extract. Diabetes, Obesity & Metabolism 6:171-
180, 2004.
11. Soni MG, Burdock GA, Preuss HG, Stohs SJ, Ohia SE, Bagchi D: Safety
assessment of (-) –hydroxycitric acid and Super Citrimax ®, a novel
calcium/potassium salt. Food and Chemical Toxicology (Accepted for publication)
12. Jena BS, Jayaprakasha GK, Singh RP, Sakariah KK: Chemistry and biochemistry
of (-)hydroxycitric acid from Garcinia. J Agric Food Chem 50:10-22, 2002.
13. Ohia SE, Olubusayo A, LeDay AM, Opere CA, Bagchi D: Effect of hydroxycitric
acid on serotonin release from isolated rat brain cortex. Res Comm Molec Pathol
Pharmacol. 109:210-216, 2001..
14. Ohia SE, Opere CA, LeDay AM, Bagchi M, Bagchi D, Stohs SJ: Mechanism of
appetite suppression by a novel hydroxycitric acid extract (HCA-SX) and its safety
profile. Molec Cell Biochem 238:89-103, 2002.

6
Report on the Safety of Caralluma Fimbriata and its Extract
Reviewed by Dr. Harry Preuss
15. Lowenstein JM. Effect of (-)-hydroxycitrate on fatty acid synthesis by rat liver in
vivo. J Biol Chem, 246:629-632, 1971.
16. Sullivan AC, Triscari J, Hamilton JG, Miller ON, Wheatley VR. Effect of (-)-
hydroxycitrate upon the accumulation of lipid in the rat. I. lipogenesis. Lipids,
9:121-128, 1974.
17. Sullivan AC, Triscari J, Hamilton JG, Miller ON. Effect of (-)-hydroxycitrate
upon the accumulation of lipid in the rat. II. appetite. Lipids, 9:129-134, 1974.
18. Triscari J, Sullivan AC. Comparative effects of (-) hydroxycitrate and (+)-allo-
hydroxycitrate on acetyl CoA carboxylase and fatty acid and cholesterol synthesis.
Lipids 12:357-363, 1977.
19. Radhakrishnan R, Zakaria M, Islam MW, Liu XM, Chan K, Habibullah M:
Antihyperglycemic effects of Caralluma arabica in diabetic mice. J Pharm
Pharmacol 51(Suppl )116, 1999.
20. Venkatesh S, Reddy GD, Reddy BM, Ramesh M, Appa Rao AVN:
Antihyperglycemic activity of Caralluma artenuata. Fitoterapia 74:274-279, 2003.
21. Zakaria MNM, Islam MW, Radhakrishnan RR, Chen HB, Ismail A, Chan K,
Habibullah M: Evaluation of antinociceptive and anti-inflammatory properties of
Caralluma arabica. J Pharm Pharmacol 51(Suppl )117, 1999.
22. Zakaria MNM, Islam MW, Radhakrishnan R, Chen HB, Kamil M, Al-Gifri AN,
Chan K, Al-Attas A: Antinociceptive and anti-inflammatory properties of
Caralluma arabica. J Ethnopharm 76:155-158. 2001.
23. Ramesh M, Rao YN, Kumar MR, Rao AV, Prabhakar MC Reddy BM:
Antinocicetive and anti-inflammatory activity of carumbelloside-I isolated from
Caralluma umbellata. J Ethnopharmacol 15:349-352, 1999.
24. Zakaria MNM, Islam MW, Radhakrishman R, Liu XM, Ismail A, Kamil M, Chan
K, Al-Attas A: Anti-gastric ulcer and cytoprotective properties of Caralluma
arabica. Pharmaceutical Biology 40:225-230, 2002.

7
 Safety and Efficacy Reviewed by :
• I would like to introduce a revolutionary, new (to Americans) plant-based remedy,
Caralluma Fimbriata, an outstanding weapon against overeating, the accumulation
of body fat, and the loss of muscle mass.”

- Nicholas Perricone, MD
7 secrets of beauty, Health and Longevity

• “I believe that Caralluma Fimbriata is safe to consume at the recommended dosage.”

- Harry Preuss, MD
The Natural Fat Loss Pharmacy

Epidemiology, Pathophysiology, and Prevention

Dr. Bagchi & Dr. Preuss

 A New Appetite Suppressant Ingredient

FIRST CLINICAL TRIAL

(Published Study)

By Dr. A. V. Kurpad

St. John’s Medical College

Bangalore, India

© Copyright by Gencor Pacific, Inc. 2004

 This article was originally published in a journal published by
Elsevier, and the attached copy is provided by Elsevier for the
author’s benefit and for the benefit of the author’s institution, for
non-commercial research and educational use including without
limitation use in instruction at your institution, sending it to specific
colleagues that you know, and providing a copy to your institution’s
administrator.
All other uses, reproduction and distribution, including without
limitation commercial reprints, selling or licensing copies or access,
or posting on open internet sites, your personal or institution’s
website or repository, are prohibited. For exceptions, permission
may be sought for such use through Elsevier’s permissions site at:

http://www.elsevier.com/locate/permissionusematerial
 ARTICLE IN PRESS

Appetite 48 (2007) 338–344

www.elsevier.com/locate/appet

Research report

Effect of Caralluma Fimbriata extract on appetite, food intake and

py
anthropometry in adult Indian men and women
Rebecca Kuriyana,, Tony Raja, S.K. Srinivasb, Mario Vaza, R. Rajendranc,

co
Anura V. Kurpada
a
Division of Nutrition, Institute of Population Health and Clinical Research, St John’s National Academy of Health Sciences, Bangalore 560034, India
b
Gencor Pacific Group, USA
c
Green Chem Limited, Domlur, Bangalore, India
Received 24 June 2006; received in revised form 11 September 2006; accepted 28 September 2006

Abstract

al
on
Caralluma fimbriata is an edible cactus, used by tribal Indians to suppress hunger and enhance endurance. The effect of Caralluma
extract was assessed in overweight individuals by a placebo controlled randomized trial. Fifty adult men and women (25–60 years) with a
body mass index (BMI) greater than 25 kg/m2 were randomly assigned into a placebo or experimental group; the latter received 1 g of
Caralluma extract per day for 60 days. All subjects were given standard advice regarding a weight reducing diet and physical activity. At
rs

the end of 30 and 60 days of intervention, blood glucose and lipids, anthropometric measurements, dietary intake and assessment of
appetite was performed. Waist circumference and hunger levels over the observation period showed a significant decline in the
experimental group when compared to the placebo group. While there was a trend towards a greater decrease in body weight, body mass
pe

index, hip circumference, body fat and energy intake between assessment time points in the experimental group, these were not
significantly different between experimental and placebo groups. Caralluma extract appears to suppress appetite, and reduce waist
circumference when compared to placebo over a 2 month period.
r 2006 Elsevier Ltd. All rights reserved.

Keywords: Caralluma; Appetite; Anthropometry; Food intake

r's

Introduction physical activity on the reduction of risk for many chronic

disorders associated with obesity. However, overweight
Obesity is a major global health problem and a risk subjects often under-report their food intake (Lissner,
factor for several chronic disorders such as diabetes, 2002; Lissner, Heitmann, & Bengtsson, 2000), and carefully
o

hyperlipidemia, hypertension and cardiovascular disease. conducted objective measurements have shown that EI is in
Weight gain and obesity are a result of positive energy fact increased in obese subjects (Lichtman et al., 1992;
th

balance due to a mismatch between energy intake (EI) and Schoeller, 1990). The complex process of appetite is
energy expenditure (EE). The EI in turn is subject to a wide controlled by several neural, humoral and psychological
range of influences, including appetite, gastro-intestinal factors (Bray, 2000), and strategies that suppress appetite
Au

signals such as distension of the stomach, chemical signals
to the gastric mucosa and blood-borne metabolites such as
glucose and fatty acids. Strategies to reduce a positive
energy balance have often focused on increasing EE since it
was thought that the EI of obese individuals was normal or
low and additionally, because of the independent effects of
Corresponding author. Tel./fax: 91 80 25532037.
E-mail address: rebecca@iphcr.res.in (R. Kuriyan).
are likely to be useful in weight loss and control. Appetite
suppressant medications, while effective often have side
effects (Haller & Benowitz, 2000).
Traditional health care systems, including herbal med-
icine are widespread in developing countries (WHO, 2002).
Certain herbs, used by native people have also been studied
for their appetite suppressing effects. This includes Hoodia
gordonii, which is a succulent from the Kalahari desert of
South Africa (MacLean & Luo, 2004). In India, Caralluma

0195-6663/$ - see front matter r 2006 Elsevier Ltd. All rights reserved.
doi:10.1016/j.appet.2006.09.013
 ARTICLE IN PRESS
R. Kuriyan et al. / Appetite 48 (2007) 338–344
fimbriata, an edible succulent cactus that belongs to the
family Asclepiadaceae is also well known as a famine food,
appetite suppressant and thirst quencher among tribal
populations. It grows wild all over India and is also planted
as a roadside shrub and boundary marker in gardens.
Native Indian diets over many centuries have included
these edible wild succulent cacti, with claims in folklore
about its appetite suppressant activity. There has been no
previous controlled study on the appetite suppressing
effects of Caralluma and this is the first study to examine
the effects of Caralluma experimentally. The aim of the
present study was to evaluate the effectiveness of Carallu-
ma fimbriata extract on appetite suppression, food choice
and anthropometry in overweight and obese individuals
who wished to lose weight.
Methods
Subjects
The study was a double blind, placebo controlled,
randomized trial. Sixty two healthy volunteers (23 male
on
and 39 female subjects) in the age group of 25–60 years,
with a body mass index (BMI) greater than 25 kg/m2 were
recruited into the study. Exclusion criteria were the
presence of any chronic disease and the use of any
rs
medication for weight loss. The subjects included
staff and individuals who visited the Nutrition Clinic of
St. John’s Medical College Hospital, Bangalore, in order to
pe
lose weight. After recruitment, the subjects were randomly
assigned into the placebo or experimental group. Twelve
subjects dropped out during the study (equal numbers in
both groups with no gender bias) and 50 subjects
completed the study, 25 subjects each in the placebo and
the experimental group. The study was approved by the
institutional ethical review committee of St. John’s Medical
r's
College and an informed consent was obtained from the
subjects.
Experimental protocol
o
The Caralluma extract was made from the aerial parts of
th
the plant with aqueous alcohol which was 40% aqueous
(40 parts of alcohol and 60 parts of water). About 12 kg of
dried herb was obtained from 100 kg of the fresh plant,
Au
which gave a final yield of 1 kg of the extract. It was then
purified, granulated and filled in capsules to deliver 500 mg
of the extract. Maltodextrin capsules (500 mg) were used as
placebo, and both capsules were prepared by Green Chem
Limited, Bangalore, India. Prior to the intervention, the
subjects underwent baseline investigations which included
anthropometric, biochemical, dietary and appetite assess-
ment. The extract was administered as two 500 mg capsules
daily (1 g/day) for 60 days, during which the subjects
reported weekly to the Nutrition Clinic to record their
body weight, collect their weekly capsule supply and report
adverse events, if any. The compliance of the subjects to the
339
ingestion of capsules was measured every week when they
reported to the Nutrition Clinic. The subjects were
provided with a capsule calendar in which they were
required to tick mark boxes relating to the daily intake of
capsules and also to note down any missed capsule. The
calendar and the ‘missed’ pill count were monitored every
week.
py
Anthropometric measurements
Anthropometric measurements included body weight,
height, skinfold thickness and mid-arm, waist and hip
co
circumferences. All the measurements were standardized
(Harrison et al., 1988). Skinfold measurements in tripli-
cates were carried out using Holtain skinfold calipers, at
four sites (i.e.) biceps, triceps, subscapular and suprailiac.
The average sum of four skinfold measurements were used
to compute body density using the age and gender specific
equations (Durnin & Womersley, 1974) and percent body
al
fat was derived from body density (Siri, 1961). These
equations were previously validated in a group of Indian
men and women (Kuriyan, Petracchi, Ferro-Luzzi, Shetty,
& Kurpad, 1998). The corrected arm muscle area (CAMA)
was calculated using the mid-arm circumference and tricep
skinfold (Heymsfield, McManus, Smith, Stevens, & Nixon,
1982). The measurements were repeated at day 30 and day
60 of the administration period.
Biochemical measurements
Fasting blood glucose and lipid profile were measured at
baseline, day 30 and day 60 of the study period. The blood
glucose, triglyceride, total and HDL cholesterol were
estimated by automated spectrophotometric assays (Dade
Behring Dimension R  L, Newark, USA), while LDL
cholesterol was calculated from primary measurements
using the empirical formula of Friedewald equation
(Friedewald, Levy, & Fredrickson, 1972). All assays were
calibrated by use of Dade Dimension human calibrator
(Dade Behring Inc, Newark, USA). The analytical
coefficient of variation (inter-assay) for total cholesterol,
triglycerides and HDL cholesterol were 4.1%, 4.7% and
4.1%, respectively.
Dietary and physical activity assessment
Dietary assessment was carried out using a modified
food frequency questionnaire with 129 food items which
was developed specifically for the urban south Indian
population (Rastogi et al., 2004). This questionnaire was
administered at the baseline and the end of the study.
A validated physical activity questionnaire (Bharathi,
Sandhya, & Vaz, 2000) was used to assess the daily
integrated physical activity of the patient at baseline, day
30 and day 60 of the study. All the study subjects were
provided with standard health advice on diet and physical
activity targeted to achieve a weight loss of about 5–10%
 ARTICLE IN PRESS
340 R. Kuriyan et al. / Appetite 48 (2007) 338–344

body weight over the study period. The compliance of the
subjects to the prescribed diet and physical activity was
assessed weekly by asking the subjects to rate their
compliance on a scale of 0–100%.
Appetite assessment
The appetite of the subject was assessed at baseline, day
height, BMI, waist, hip circumferences and percent body
fat between the experimental and placebo groups.
The anthropometric parameters of the subjects in the
experimental and placebo groups at various time points of
the study are summarized in Table 2. A significant
interaction effect was observed between time and the
group (repeated measure ANOVA) in the waist circumfer-
ence. There were no significant differences observed in the

30 and day 60 of the study in the fasted state. Four 100 mm
visual analogue scales (VAS, Silverstone, 1981) for
‘hunger’, ‘thoughts of food’, ‘urge to eat’, and ‘fullness of
stomach’ were administered. The scale was administered
py
change of body weight, BMI, hip circumference and
percent body fat over time between the two groups
(repeated measure ANOVA). At the end of the study
period, significant decreases in body weight, BMI, waist

each time, in triplicate. The mean of the three readings was
expressed as a percentage of the scale.
Statistics
The data are presented as Mean7SD. An independent
‘t’ test analysis was performed to ascertain whether
co
and hip circumferences were observed only in the experi-
mental group, when compared to baseline parameters
(po0:01). The weight loss in the experimental group
accounted to 2.5% (2 kg) of the initial body weight. In
contrast the placebo group had a non-significant reduction
of 1.3% (1 kg) during the study period. In the placebo
group, the only significant change observed was in the hip

significant differences existed between the physical char-
acteristics of the subjects in the experimental and placebo
group at baseline. A repeated measure ANOVA with group
on
as a factor was performed to assess the change over time in
the anthropometric, biochemical and visual analog scale
parameters between the two groups. The repeated measure
ANOVA was then used to assess for significant differences
rs
al
circumference which significantly decreased at month 1
when compared to the baseline values.
The data on appetite assessment from the VAS and on
dietary intake assessment are presented in Table 3. The
mean ‘hunger levels’ at baseline of the experimental group
tended to be higher (but not significantly) when compared
to placebo group, while at day 60 the mean ‘hunger levels’

between the various time points in the subjects of both of the experimental group was significantly lower than
groups independently. The paired ‘t’ test analysis was those of the placebo group; this accounts for the significant
carried out to ascertain significant differences in the mid- interaction effect between time and the group (repeated
pe

arm circumference, CAMA and in the food intake of
subjects belonging to both the groups between the time
points. The significance level was set at po0:05.
Results
The physical characteristics of the subjects in the
r's
measure ANOVA). There were no significant differences
observed in the change of ‘thought of food’, ‘feeling of
fullness’ and ‘urge to eat’ over time between the two groups
(repeated measure ANOVA). By the end of the study
period, the experimental group had a 7.2% increase in the
‘feeling of fullness’ (NS), a 9.5% decrease in ‘urge to eat’
(NS) and 19.7% decrease in ‘hunger’ levels (po0:05).

Corresponding changes in the placebo group were 0.8%,

experimental and placebo groups are summarized in Table
1.8%, 1.2% (all NS). Changes in ‘thoughts of food’’ were
1. The age range of the subjects in the experimental group
minimal in both groups (1.3%) in experimental group,
was 28–53 and 28–52 years in the placebo group. There
1.1% in the placebo group and not significant. Significant
were no significant differences in the mean age, weight,
o

reductions (po0:05) in energy and macronutrient intake at

the end of the study period were observed only in the
Table 1
th

Physical characteristics of the subjects experimental group. This amounted to 188 kcal/day (8.2%)
for energy, 20 g (5.2%) for carbohydrate, 4.7 g (8%) for fat
Parameter Experimental Placebo group and 3.6 g (5.7%) for protein. Further, the intake of cereals,
group (n ¼ 25) (n ¼ 25)
Au

roots and tubers, sugars and sweets, egg and meat products
Age (yr) 38.677.8 38.976.1 in the experimental group was significantly lower at the end
Body weight (kg) 79.5716.9 78.279.3 of the study when compared to the baseline, while the
Height (cm) 160.979.1 162.379.4 intake of fruits, vegetables and fish remained the same.
Body mass index (kg/m2) 30.675.5 29.873.9 In the placebo group of subjects, there was no change in
Waist circumference (cm) 96.9711.6 95.179.6
Hip circumference (cm) 106.3711.4 107.377.2
the intake of nutrients, or in food groups at the end of
Percent body fat (%) # 34.675.6 34.275.4 the study.
The biochemical parameters of the subjects belonging
Mean7standard deviation (SD). to both the experimental and the placebo group are
#—Calculated from the sum of four skinfold measurements and applying
the formulae of Durnin and Womersley (1974).
presented in Table 4. There were no significant differences
No significant differences were observed between the physical character- observed in the change of the biochemical parameters
istics of the subjects of the two groups (independent ‘t’ test). over time between the two groups (repeated measure
 ARTICLE IN PRESS
R. Kuriyan et al. / Appetite 48 (2007) 338–344 341

Table 2
Anthropometric parameters of the subjects at baseline, day 30 and day 60 of the study

Parameter Baseline Day 30 Day 60 F value p value

Body weight (kg)

Experimental 79.5716.9 78.3716.5a 77.5716.0a,b 1.9 0.15
Placebo 78.279.3 77.578.9 77.278.6
Body mass index (kg/m2)

py
Experimental 30.675.5 30.275.6a 29.975.6a,b 2.1 0.13
Placebo 29.873.9 29.674.0 29.574.0
Waist circumference(cm)
Experimental 96.9711.6 95.1712.0a 93.9711.3a,b 6.8 o0.001c

co
Placebo 95.179.6 94.479.43 94.379.6
Hip circumference(cm)
Experimental 106.3711.4 105.8711.5 105.0711.6a,b 2.06 0.13
Placebo 107.277.2 106.477.9a 106.477.0
Percent fat (%) #
Experimental 34.675.6 34.275.3 33.475.6a 2.8 0.07
Placebo 34.275.9 34.175.5 34.075.4

al
Mean7SD.
#—Calculated from the sum of two, three or four skinfold measurements and applying the formulae of Durnin and Womersley (1974)
a
Mean value was significantly different from that of baseline (repeated measure ANOVA; po0:05).
b
on
Mean value was significantly different from that of Day 30 (repeated measure ANOVA; po0:05).
c
Significant interaction between time points and group (repeated measure ANOVA with group as between subjects factor).

Table 3
rs

Appetite and food intake assessment

Parameter Study group Baseline (Day 0) Day 30 Day 60 F value p value

pe

Thoughts of food (%) Experimental 34.5724.3 36.2721.6 33.2723.6 1.6 0.21

Placebo 33.1720.3 33.6715.3 32.0717.5

Feeling fullness (%) Experimental 33.3719.3 41.7720.5 40.5721.9 0.84 0.44

Placebo 37.8726.9 36.6717.9 38.6721.2
Urge to eat (%) Experimental 44.0725.3 39.3721.5 34.5721.2 1.78 0.18
Placebo 35.3725.3 35.2717.5 33.5719.7
Hunger (%) Experimental 47.6722.6 39.2721.4 27.9718.8a 6.6 o0.001b
r's

Placebo 41.9724.1 41.6717.3 40.7718.9

Energy intake (kcal/day)c Experimental 2276.57202.3 2088.87183.4d
Placebo 2303.67107.9 2299.07109.0
o

Fat intake (g/day)c Experimental 59.076.4 54.373.9d

Placebo 61.772.8 60.973.9
th

Carbohydrate intake (g/day)c Experimental 360.9726.1 340.5723.7d

Placebo 377.9721.1 376.8721.3
Protein intake (g/day)c Experimental 62.976.3 59.377.2d
Au

Placebo 59.174.5 59.374.8

Mean values7Standard deviation.The appetite assessment was carried using Visual Analog Scales and results were expressed as percentage of the scale.
a
Mean value was significantly different from that of baseline (repeated measure ANOVA; po0:05).
b
Significant interaction between time points and group (repeated measure ANOVA with group as between subjects factor). Significant differences
between time points were assessed using repeated measure ANOVA with post hoc corrections.
c
These parameters were measured twice and no interaction term is available. The food intake assessment was carried using food frequency
questionnaires at baseline and end of the study and significant differences between time points were assessed using paired ‘t’ test.
d
Mean value was significantly different from that of baseline.

ANOVA). There were no significant differences observed The mean compliance of the subjects in the experimental
between the time points in both the experimental and group to prescribed diet was 72% (55–88%) and 70%
placebo group. (53–88%) to prescribed physical activity, while in the
 ARTICLE IN PRESS
342 R. Kuriyan et al. / Appetite 48 (2007) 338–344

Table 4
Biochemical parameters of the subjects at baseline, Day 30 and Day 60 of the study

Parameter Baseline Day 30 Day 60 F value p value

Fasting blood sugar (mg/dl)

Experimental 89.8716.8 89.3710.3 88.9710.4 0.05 0.95
Placebo 90.5714.3 89.0710.9 91.7711.1
Post prandial sugar (mg/dl)

py
Experimental 110.9735.3 108.3725.2 108.6727.2 0.69
Placebo 101.9721.9 106.1718.1 104.3725.0 0.50
Total cholesterol (mg/dl)
Experimental 192.5727.1 191.0725.9 191.8727.0

co
Placebo 195.1736.3 194.8739.2 196.2737.3 0.01 0.99
HDL cholesterol (mg/dl)
Experimental 65.9711.0 63.6710.0 64.17 9.95 0.53 0.59
Placebo 56.3710.8 55.6713.1 56.1711.0
LDL cholesterol (mg/dl)
Experimental 120.0739.8 118.0727.9 115.7730.3
Placebo 124.3738.2 126.3746.4 128.9754.6 0.71 0.50

al
Serum triglycerides (mg/dl)
Experimental 111.9752.0 112.1755.0 110.3751.5 0.19 0.82
Placebo 101.8744.3 102.3737.9 101.3738.4
on
Mean7SD.
No significant differences in the biochemical parameters at various time points. Significant interaction between time points and group were assessed using
repeated measure ANOVA with group as between subjects factor Significant differences between time points were assessed using repeated measure
ANOVA with post hoc corrections.
rs

placebo group it was 67% (50–87%) to prescribed diet and nutrients (Beckman et al., 2005). Appetite therefore plays
72% (53–88%) to prescribed physical activity. The physical an important role in weight regulation, and obese
pe

activity level (PAL) of both the experimental and placebo
group did not change significantly during the study. The
PAL of the experimental group was 1.5970.03 at the start
of the study and 1.5870.08 at the end of the study period,
while in the placebo group, it was 1.5970.03 at the start of
the study and 1.6070.02 at the end of the study period.
There were no serious adverse events reported by the
r's
individuals have been shown to have an increased appetite
and eating disorders such as binge eating, night eating or
compulsive overeating disorders (Keefe, Wyshogrod,
Weinberger, & Agras, 1984; Spitzer et al., 1991). Thus
measures to reduce appetite of overweight and obese
individuals could help in preventing further weight gain
and in enhancing weight reduction.

subjects of the present study. The observed adverse events
were minor and limited to initial mild symptoms of the
gastrointestinal tract such as abdominal distention, flatu-
lence, constipation and gastritis. Six (24%) of the subjects
o
Herbs contain a wide variety of active phytochemicals,
such as flavanoids, terpenoids, lignans, polyphenols,
saponins, plant sterols and cartenoids, and there is now a
lot of interest in herbs that possess hypolipidemic,

from the experimental group and five (20%) of the subjects antiplatelet, anti-tumour and immune stimulating proper-
from the placebo group experienced these minor adverse ties (Craig, 1999). Caralluma fimbriata, which grows
th

effects. These symptoms were present in both the experi- widely in India, is associated with folklore of appetite
mental and placebo group of subjects. The symptoms reduction, and it is of interest to verify this effect through
subsided within a week in all subjects. An animal study controlled studies. There are several varieties of Caralluma
Au

(Kurpad et al., unpublished) conducted to determine the
LD50 of the extract did not reveal any toxicity and the
LD50 was greater than 5g/kg.
Discussion
Food consumption in humans is regulated through a
number of complex biological mechanisms which ensures
that body weight is relatively constant over long periods.
Appetite regulates the body’s desire for food through a
complex biological process designed to satisfy the body’s
need for energy, protein, fat, carbohydrates and other
that grow in India although these species are botanically
and phytochemically similar. The key phytochemical
ingredients in Caralluma are pregnane glycosides, flavone
glycosides, megastigmane glycosides, bitter principles,
saponins and various other flavonoids (Bader, Braca, De
Tommasi, & Morelli, 2003). The appetite suppressing
action of Caralluma could be attributed to the pregnane
glycosides, which are particularly rich in plants belonging
to the Asclepiadaceae family (Christiane, Klaus, &
Eberhard, 1993). It is unclear as to how pregnane glyco-
sides or its related molecules may suppress appetite, and it
is thought that they amplify the signaling of the energy
 ARTICLE IN PRESS
R. Kuriyan et al. / Appetite 48 (2007) 338–344
sensing function in the basal hypothalamus (MacLean &
Luo, 2004). A similar appetite suppressing action has been
observed in the South African cactus-like plant Hoodia, in
which a steroidal glycoside was isolated, which demon-
strated anorectic activity in animals (MacLean & Luo,
2004).
In the present study, the hunger levels of the subjects
decreased by 20% after the administration period and this
could account for the 8% decrease in the EI of the
experimental group of subject. However, it should be
remembered that food intake could tend to be under/over
estimated and there could also be individual variations.
The 8% significant calorie deficit (amounting to about
187 kcal/day), if lost as purely fat, would account for a
weight loss of about 1.25 kg over the study period. The
actual weight loss would have been more if some lean tissue
(protein has a lower heat equivalent) was also lost. The
observed weight loss in the experimental group of subjects
was about 2 kg, while the loss of fat mass was 1.5 kg after 2
months of intervention. This weight loss can therefore be
explained by the EI deficit. It seems unlikely that significant
amounts of muscle mass may have been lost, since, first,
on
there was a significant decrease of about 3 cm in the waist
circumference, second, the mid-arm circumference (which
admittedly is measure of both muscle and fat) of the
experimental group did not change (32.1+2.1 cm vs.
rs
32.2+2.1 cm, day 0 and day 60, respectively, P ¼ 0:87).
The CAMA also did not change (56.5+7.2 cm2 vs.
56.7+7.3 cm2 between day 0 and day 60, respectively,
pe
P ¼ 0:84) and third, the subjects in general followed their
physical activity advice with a compliance of about 70%.
The decline in waist circumference (3 cm in 2 months) is
important since waist circumference is reflective of intra-
abdominal fat which is strongly associated with risks of
metabolic and cardiovascular disease and risk of other
chronic non communicable diseases (Despres, 2006;
r's
Despres et al., 1990; Reeder et al., 1997). Abdominal
adiposity is also associated with insulin resistance (Carey,
Jenkins, Campbell, Freund, & Chisholm, 1996; Kissebah
et al., 1982). The waist circumference is a convenient
o
measure of intra-abdominal adipose tissue (Han, van
Leer, Seidell, & Lean, 1995; Pouliot et al., 1994), and has
th
been described as a risk factor independent of BMI
for cardiovascular disease (Rexrode et al., 1998). It is
particularly important in Indians who seem to have a
Au
predilection for accumulation of fat in this region (Anjana
et al., 2004; Raji, Seely, Arky, & Simonson, 2001;
Ramachandran et al., 2001). It is not clear why the waist
circumference specifically declined in this study indepen-
dent of body weight. While one possibility is that this was
simply an early indicator over the relatively short inter-
vention, the other possibility is that fat in different depots
of the body have different rates of lipolysis during negative
energy balance or fasting (Monzon, Basile, Heneghan,
Udupi, & Green, 2002), if it can be assumed that there
was a negative energy balance induced by the intake
of Caralluma extract. Even under lipolytic stimuli like
343
noradrenaline stimulation for instance, subcutaneous
fat in the anterior abdominal wall has a different rates of
lipolysis when compared with whole body lipolytic rates
(Kurpad et al., 1994).
An additional intriguing feature observed in the experi-
mental group of subjects was a significant reduction in the
intake of refined sugars, sweets, cholesterol and saturated
fats at the end of the study, while the intake of fruits,
py
vegetables and fish remained unchanged. The consumption
of foods such as whole grains, fruits and vegetables has
been found to be directly associated with reduction in
hunger and increased satiety levels, which could lead to
co
lowered voluntary energy intake (Roberts & Heyman,
2000). Similarly, the reduction in fat intake as a means to
reduce EI results in weight loss (Bray & Popkin, 1998). The
subjects in the experimental group seemed to have made
healthy food choices in their diet after 2 months of the
administration period, compared to the placebo group.
This interesting aspect of the effect of Caralluma needs
al
more study. We were unable however to explain the lack of
any change in the lipid values of the experimental group,
despite the reduction in the intake of cholesterol and
saturated fats.
The results of the present study suggest that Caralluma
fimbriata has a potential appetite suppressing action. This
concurs with the anecdotal evidence provided by tribal
populations in India. While there was no significant effect
of Caralluma on body weight, there was a significant
reduction in waist circumference. The effect of appetite
suppression translated into a net effect of a reduction in
energy and fat intake and was accompanied by a reduction
in intake of less desirable food groups, while the intake of
desirable (healthy) food groups remained unchanged.
Acknowledgements
This study was supported by Gencor Pacific Group,
USA. We thank Ms. Tinku Thomas, statistician, Institute
of Population Health and Clinical Research, St. John’s
National Academy for Health Sciences for her help in the
statistical analysis.
References
Anjana, M., Sandeep, S., Deepa, R., Vimaleswaran, K. S., Farooq, S., &
Mohan, V. (2004). Visceral and central abdominal fat and anthro-
pometry in relation to diabetes in Asian Indians. Diabetes Care, 27,
2948–2953.
Bader, A., Braca, A., De Tommasi, N., & Morelli, I. (2003). Further
constituents from Caralluma negevensis. Phytochemistry, 62,
1277–1281.
Beckman, T., Shi, Q., & Billington, C. (2005). The brain and the biology of
obesity. Minnesota Medicine, 88(9), 58–61.
Bharathi, A. V., Sandhya, N., & Vaz, M. (2000). The development and
characteristics of a physical activity questionnaire for epidemiological
studies in urban middle class Indians. Indian Journal of Medical
Research, 111, 95–102.
Bray, G. A., & Popkin, B. M. (1998). Dietary fat intake does affect
obesity. American Journal of Clinical Nutrition, 68, 1157–1173.
 ARTICLE IN PRESS
344 R. Kuriyan et al. / Appetite 48 (2007) 338–344
Carey, D. G., Jenkins, A. B., Campbell, L. V., Freund, J., & Chisholm, D.
J. (1996). Abdominal fat and insulin resistance in normal and
overweight women: Direct measurements reveal a strong relationship
in subjects at both low and high risk of NIDDM. Diabetes, 45,
633–638.
Christiane, S., Klaus, R., & Eberhard, B. (1993). Liebigs Annual
Chemistry, 10, 1057.
Craig, W. J. (1999). Health promoting properties of common herbs.
American Journal of Clinical Nutrition, 70, 491S–499S.
Despres, J. P. (2006). Intra-abdominal obesity: An untreated risk factor
for Type 2 diabetes and cardiovascular disease. Journal of Endocrino-
logical Investigation, 29(3 Suppl), 77–82.
Despres, J. P., Moorjani, S., Lupien, P. J., Tremblay, A., Nadeau, A., &
Bouchard, C. (1990). Regional distribution of body fat, plasma
lipoproteins, and cardiovascular disease. Arteriosclerosis, 10, 497–511.
Durnin, J. V. G. A., & Womersley, J. (1974). Body fat assessed by total
body density and its estimation from skinfold thickness: Measurements
on 481 men and women aged 16–72 years. British Journal of Nutrition,
32, 77–97.
Friedewald, W. T., Levy, R. I., & Fredrickson, D. S. (1972). Estimation of
the concentration of low-density lipoprotein cholesterol in plasma,
without use of the preparative ultracentrifuge. Clinical Chemistry, 18,
499–502.
Haller, C. A., & Benowitz, N. L. (2000). Adverse cardiovascular and
central nervous system events associated with dietary supplements
containing ephedra alkaloids. New England Journal of Medicine,
343(25), 1833–1838.
Han, T. S., van Leer, E. M., Seidell, J. C., & Lean, M. E. (1995). Waist
circumference action levels in the identification of cardiovascular risk
factors: Prevalence study in a random sample. British Medical Journal,
25, 1401–1405.
rs
Harrison, G. G., Buskirk, E. R., ECarter, L., Johnston, F. E., Lohman, T.
G., Pollock, M. L., et al. (1988). Skinfold thicknesses and measurement
technique. In T. G. Lohman, A. F. Roche, & R. Martorell (Eds.),
Anthropometric standardization reference manual (pp. 55–71). Illinois:
pe
Human Kinetics Books.
Heymsfield, S. B., McManus, C., Smith, J., Stevens, V., & Nixon, D. W.
(1982). Anthropometric measurement of muscle mass: Revised
equations for calculating bone-free arm muscle area. American Journal
of Clinical Nutrition, 36, 680–690.
Keefe, P. H., Wyshogrod, D., Weinberger, E., & Agras, W. S. (1984).
Binge eating and outcome of behavioral treatment of obesity: A
preliminary report. Behavioral Research Therapy, 22, 319–321.
r's
Kissebah, A. H., Vydelingum, N., Murray, R., Evans, D. J., Hartz, A. J.,
Kalkhoff, R. K., et al. (1982). Relation of body fat distribution to
metabolic complications of obesity. Journal of Clinical Endocrinology
and Metabolism, 54, 254–260.
Kuriyan, R., Petracchi, C., Ferro-Luzzi, A., Shetty, P. S., & Kurpad, A. V.
o
(1998). Validation of expedient methods for measuring body composi-
tion in Indian adults. Indian Journal of Medical Research, 107, 37–45.
th
Kurpad, A., Khan, K., Calder, A. G., Coppack, S., Frayn, K.,
Macdonald, I., et al. (1994). Effect of noradrenaline on glycerol
turnover and lipolysis in the whole body and subcutaneous adipose
tissue in humans in vivo. Clinical Science(London), 86, 177–184.
Au
Lichtman, S. W., Pisarska, K., Raynes Berman, E. R., Pestone, M.,
Dowling, H., Offenbacher, E., et al. (1992). Discreptancy between
self-reported and actual caloric intake and exercise in obese subjects.
New England Journal of Medicine, 327, 1893–1898.
Lissner, L. (2002). Measuring food intake in studies of obesity. Public
Health Nutrition, 5(6A), 889–892.
Lissner, L., Heitmann, B. L., & Bengtsson, C. (2000). Population studies
of diet and obesity. British Journal of Nutrition, 83(Suppl 1), S21–S24.
MacLean, D. B., & Luo, L. G. (2004). Increased ATP content/production
in the hypothalamus may be a signal for energy-sensing of satiety:
Studies of the anorectic mechanism of a plant steroidal glycoside.
Brain Research, 1020, 1–11.
py
Monzon, J. R., Basile, R., Heneghan, S., Udupi, V., & Green, A. (2002).
Lipolysis in adipocytes isolated from deep and superficial subcuta-
neous adipose tissue. Obesity Research, 10, 266–269.
Pouliot, M. C., Despres, J. P., Lemieux, S., Moorjani, S., Bouchard, C.,
co
Tremblay, A., et al. (1994). Waist circumference and abdominal
sagittal diameter: Best simple anthropometric indexes of abdominal
visceral adipose tissue accumulation and related cardiovascular risk in
men and women. Amercian Journal of Cardiology, 73, 460–468.
Raji, A., Seely, E. W., Arky, R. A., & Simonson, D. C. (2001). Body fat
distribution and insulin resistance in healthy Asian Indians and
Caucasians. Journal of Clinical Endocrinolgy and Metabolism, 86,
5366–5371.
Ramachandran, A., Snehalatha, C., Kapur, A., Vijay, V., Mohan, V.,
al
Das, A. K., et al. (2001). Diabetes Epidemiology Study Group in India
(DESI). High prevalence of diabetes and impaired glucose tolerance in
India: National Urban Diabetes Survey. Diabetologia, 44, 1094–1101.
on
Rastogi, T., Reddy, K. S., Vaz, M., Spiegelman, D., Prabhakaran, D.,
Willett, W. C., et al. (2004). Diet and risk of ischemic heart disease in
India. American Journal of Clinical Nutrition, 79, 582–592.
Reeder, B. A., Senthilselvan, A., Despres, J. P., Angel, A., Liu, L., Wang,
H., et al. (1997). The association of cardiovascular disease risk factors
with abdominal obesity in Canada. Canadian Heart Health Surveys
Research Group. Candian Medical Association Journal, 1(Suppl 1),
S39–S45.
Rexrode, K. M., Carey, V. J., Hennekens, C. H., Walters, E. E., Colditz,
G. A., Stampfer, M. J., et al. (1998). Abdominal adiposity and
coronary heart disease in women. Journal of American Medical
Association, 280, 1843–1848.
Roberts, S. T., & Heyman, M. B. (2000). Dietary composition and
obesity: Do we need to look beyond dietary fat? Journal of Nutrition,
130, 267S.
Schoeller, D. A. (1990). How accurate is self-reported dietary energy
intake? Nutrition Review, 48, 373–379.
Silverstone, T. (1981). Techniques for evaluating antiobesity drugs in man.
In P. Bjorntorp, M. Cairella, & A. N. Howard (Eds.), Recent advances
in obesity research (pp. 173–179). London: John Libbey.
Siri, W. E. (1961). Body composition from the fluid spaces and sensity:
Analysis of methods. In J. Brozek, & A. Henschel (Eds.), Techniques
for measuring body composition (pp. 223–244). Washington: National
Academy of Sciences NRC.
Spitzer, R. L., Stunkard, A., Yanovski, S., Marcus, M. D., Wadden, T., &
Wing, R. etal. (1991). Binge eating disorders: Its further validation
in a multisite study. International Journal of Eating Disorders, 13,
137–153.
WHO. (2002). WHO traditional medicine strategy 2002–2005. Geneva:
World Health Organization.
 SLIMALUMA® First Clinical Study:
Average Reduction

4.50

4.00

3.50

3.00

2.50

2.00

1.50

1.00

0.50

0.00
BMI Weight (lb) Waist (In)
Active 0.78 4.27 1.09
Placebo 0.68 2.48 0.54
Paris Anti-Obesity Therapie 2006 | May 18-19 2006
„ Home Accepted Abstracts:
„ Hot Topics
„ Main Informations
„ Innovation Award
„ Program
„ Accepted Abstracts
„ Registration
„ Place / Hotel
„ Exhibition stands /
Brochures insertion
„ Sponsoring
„ Continuous Medical
Education (CME)
„ Back to ISANH
Scientific Contact :
Dr Sandra Huguenin - SFA
15, rue de la Paix
75002 Paris
FRANCE
Tél : 01.55.04.77.55
Fax : 01.55.04.77.57
anti-obesity2006@wanadoo.fr
http://www.isanh.com/anti-obesity/2006/abstracts.php
Page 1 of 3
z Transgenic rabbits overexpressing human apob mrna editing gene (apobec-1) are obese
Georges Gaudriault*, Bénédicte Fournes, Sandrine Braud, Christelle Mougin, Celine
Viglietta**, Louis- Marie Houdebine** and Itzik Harosh*
* ObeTherapy Biotechnology 4, Evry, France
** Unité de Différenciation Cellulaire – INRA, Jouy-en-Josas, France
z Effect of caralluma fimbriata extract on appetite and weight control
R Raj, SK Srinivas, T Raj, R Rajendran , AV Kurpad
Division of Nutrition - Institute of Population Health and Clinical Research - St. John’s National Media Partners
Academy of Health Sciences, Bangalore, INDIA
z Synergistic acting of mixture of herbs extracts as an adjunct in the dietary treatment of
obesity. Results from a randomized, double blind, placebo controlled study
K. Linke*, J-M. Gaullier**, O. Gudmundsen**, I. Krela-Kazmierczak*, M. Krotkiewski***
* Department of Gastroenterology, Academy of Medicine, Poznan, Poland Cahier de Nutrition et
** Scandinavian Clinical Research AS, Norway Diététique
*** Department of Clinical Neuroscience, The Sahlgrenska Academy at Göteborg University, (Société Française de
Sweden Nutrition)
z INOS gene disruption potentiates the anti-diabetic effects of rosiglitazone in obese mice:
role of the adiponectin-ampk pathway
P. Dallaire*, Mathieu Laplante**, Patrice Penfornis*, Maria Trujillo***, Philipp E. Scherer***,
Yves Deshaies** and André Marette*
* Lipid research Unit, CHUL Research Centerr, Laval University, Québec, Québec,Canada European Journal of
** Laval Hospital Research Center, Laval University, Québec, Québec,Canada Nutrition
*** Departments of Cell Biology, Albert Einstein College of Medicine, Bronx, New York, USA
z Effect of different treatments on weight reduction among selected adult obese women
Vijayalakshmi Purushothaman and R.Parimala
Avinashilingam Deemed University, Coimbatore, Tamil Nadu, India
z Effect of remedial measures on selected adult obese women
Vijayalakshmi Purushothaman and R.Parimala
Avinashilingam Deemed University, Coimbatore, Tamil Nadu, India Journal of
Endocrinological
z Physiological characterization of monosodium glutamate and diet-induced obesity in inbred Investigation
and outbred mice
L. Maletínská*, R. Shamas Toma*, J. Maixnerová*, J. Slaninová*, Z. Pirnik***, A. Kiss***, and
B. Železná**
* Institute of Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic,
Prague, Czech Republic
** Institute of Molecular Genetics, Academy of Sciences of the Czech Republic, Prague, Czech
Republic Obesity and Metabolism
*** Institute of Experimental Endocrinology, Slovak Academy of Sciences, Bratislava, Slovakia
z Proinflammatory cytokine polymorphisms and the risk of obesity
F Pereira*, AC Santos**, JC Machado*, H Barros** Obesity reviews
* IPATIMUP - Institute of Molecular Pathology and Immunology of the University of Porto, Portugal.
** Serviço de Higiene e Epidemiologia, Faculty of Medicine of the University of Porto, Portugal.
z Obesity prevention in pediatrics: A Pilot Resident Curriculum Intervention
Jose Gonzalez
z Activation of nuclear hormone receptors by Guggulipids and its component commipheric
Info veille biotech
acid
C. Cornick*, B. Strongitharn**, J. Rogers**, G. Sassano**, C. Rawlins**, A. Mayes, M.A.
Cawthorne*, L. Brown**, J.R.S. Arch*
* Clore Laboratory, University of Buckingham, UK
** Unilever Research, Colworth House, UK
z The effect of an extract of cissus quadrangularis (cylaris™) on weight and serum lipids in
obese patients in cameroon: a randomized double blind clinical trial
J. Oben, D. Mandob, G. Fomekong, G. Agbor and C. Momo
Laboratory of Nutrition and Nutritional Biochemistry, Department of Biochemistry, B.P. 812,
University of Yaounde I, Yaounde, Cameroon.
Santor
z Serotonin and noradrenaline reuptake inhibitors significantly decrease body weight of diet-
induced obese rats
J.J. Marshall, A. Claringbold, H. Sale and S. Westbrook,
Pfizer Global Research and Development, Ramsgate Road, Sandwich, Kent CT13 9NJ
z Omental adipose tissue ZFP36 mRNA abundance is correlated with fasting insulin, insulin
resistance (HOMA-ir) index and plasma adiponectin levels in women
Bouchard L (1,2,3), Vohl MC (1,2,3), Deshaies Y (4,5), Dupont P (6), Daris M (6) and Tchernof
A (2,3,7). Diabetes, Nutrition and
1 Lipid Research Center, CHUQ pavilion CHUL; Metabolism
2 Institute of Nutraceuticals and Functional Foods, Laval University;
3 Departement of Food Science and Nutrition, Laval University;
4 Laval Hospital Research Center;
5 Department of Anatomy and Physiology; Laval University;
6 Gynecology Unit, CHUQ pavilion CHUL;
7 Molecular Endocrinology and Oncology Research Center, CHUQ pavilion CHUL;
Annals of Nutrition and
Québec, Québec, Canada.
Metabolism
12/14/2006
 A New Appetite Suppressant Ingredient

SECOND CLINICAL TRIAL

By Dr. Ronald Lawrence

Western Geriatric Research Institute

Los Angeles, CA, USA

© Copyright by Gencor Pacific, Inc. 2004

 CARALLUMA FIMBRIATA IN THE TREATMENT OF OBESITY

Ronald M. Lawrence and Suneeta Choudhary

Western Geriatric Research Institute, Los Angeles, California, United States

ABSTRACT

This study consisted of 26 overweight patients, 19 on the active compound,

Caralluma fimbriata, and 7 on placebo, who were followed for four weeks.
Caralluma fimbriata has been used in Indian folklore medicine for centuries as an
appetite suppressant that leads to long-term weight loss. The substance is well
known in Ayurvedic medicine. It has shown a long safety record with little, if any,
side effects. The substance showed a statistically significant reduction in
bodyweight and was well tolerated.

INTRODUCTION

Obesity is a global problem which is serious enough to warrant medical

intervention. It is a direct causal contributor to the pathophysiology of many diseases and
exacerbates numerous others. Among these are five of the leading causes of death in the
industrialized world: stroke, atherosclerosis, cardiovascular disease, diabetes, and
cancer1[1].
According to the World Health Organization (WHO), obesity accounts for tens of
billions of dollars in direct health care costs worldwide. A panel of experts convened by
WHO stated on June 12, 1997 that “obesity’s impact is so diverse and extreme that it
should now be regarded as one of the greatest neglected health problems of our time. It
has an impact on health which may well prove to be as great as that of smoking.”2[2]
Conventional medicine offers limited pharmaceutical options for the management
of obesity. These include lipase inhibitors, appetite suppressants, and central nervous
system stimulants. Unacceptable side effects occur as a consequence of altered
transmitter function. These include increased heart rate, hypertension, anxiety, mood
alterations, diaphoresis, dizziness, swelling of the extremities, dryness of mouth,
constipation, and insomnia.3[3]
Clearly, conventional pharmaceutical drugs are limited in the benefits they can
offer to obese patients. They would be contraindicated in several clinical settings. For
example, an obese patient with hypertension cannot be prescribed such drugs. Similarly,
coronary artery disease, cardiomegaly, and chronic G.I. ailments like irritable bowel
syndrome are clear contraindications for the use of conventional drugs for obesity
management. Since such disease conditions are usually concomitant with obesity, there
remains a large segment of obese patients who cannot benefit from conventional
pharmaceutical intervention.4[4]
The Caralluma species of succulents is known to possess several therapeutic
properties, one of them being appetite suppression leading to clinically significant weight
loss. Caralluma fimbriata extract is a new dietary ingredient for appetite suppression
which can lead to weight loss, based upon its long history of use in India, and published
reports in scientific literature.

DESCRIPTION

This large group of succulents grows wild in Africa, the Canary Islands, India,
Arabia, Southern Europe, Ceylon, and Afghanistan. The plants of this group have been
used in India for centuries. Today, as in the past, it is used as an appetite suppressant
leading to long-term weight loss, which has earned it the name of “famine food” in
India.5[5] It is commonly used as a vegetable in India’s semi-arid regions. C. fimbriata is
eaten raw or cooked with spices, and it is also used in pickles and chutneys.6[6] Indian
tribal people are known to chew chunks of C. fimbriata to suppress hunger when on a
day’s hunt. The cactus is used among the labor class in South India to suppress appetite
and enhance endurance.7[7]
A double-blind study was conducted in the Division of Nutrition of St. John’s
Medical College and Hospital in Bangalore, India (Unpublished). This study was
conducted on 62 obese patients. There was a statistically significant decrease in body
weight in the active group between all time points. This study was conducted over a two-
month period. The only adverse effects noted were gastrointestinal in nature and were
reported by both active and placebo groups. These included increased acidity (moderate),
constipation (mild), and flatulence (mild to moderate), and subsided within a week after
commencement. No adverse effects were noted on any systemic functions. No changes
in electrocardiographs were noted. No sympathomimetic effects were noted. No adverse
effects were noted, therefore, on systemic blood pressure, which was tested in all
individuals.

MATERIALS AND METHODS

The Caralluma fimbriata extract was prepared by Green Chem, a recognized

manufacturer of herbal extracts and formulations located in Bangalore, India. The
substance was prepared from plants grown under controlled conditions and harvested
from a hygienic farm in Bangalore. The substance was subjected to ether fractionation of
the defatted ethanol extract of the aerial parts of the plant. This substance was
encapsulated in a standard gelatin capsule at 500 mg. per capsule.
 Our subjects were taken from two active practices in the Los Angeles area. The
subjects were randomly assigned to either the active group or a placebo group. The trial
was carried out on 26 patients, 9 of whom were males. They ranged in age from 31
through 73. One patient from each category did not show up for the final visit (dropouts).
All patients signed an informed consent. The substance was administered as one capsule
to be taken 30 minutes before each meal. Each subject was weighed (pounds) before and
after completion of the study, height was ascertained at each visit, and the waist was
measured in inches as well as the hips. The hips were measured at the widest girth while
the waist was measured at the umbilicus. In addition, the blood pressure was measured in
a standard fashion at the brachial artery in the left upper extremity. From the weight and
height measurements, we ascertained the body mass index (BMI) of each subject.
This study was continued for four weeks. Patients were instructed not to change
their daily activity pattern (exercise), or their food intake. They were told not to change
their diet in any way from the preceding four weeks before they began taking the
substance.
Note is made that an extensive LD50 safety pharmacological study was
performed at St. John’s Medical College in Bangalore, India. The test was conducted
according to the OECD Guidelines for testing of chemicals (Acute Oral toxicity – Fixed
Dose method). No mortality was observed in rats following the administration of
CIE/2003 (Carulluma fimbriata) at a very high dose of 5 grams per kilogram of body
weight.

RESULTS AND SUMMARY

The study was conducted with 26 patients. Nineteen patients were on the active
compound and 7 were on placebo. One patient from each category did not show up for
the final visit. Almost every patient taking the active ingredient lost significant weight.
There was almost no weight loss observed in patients on placebo.
Out of 18 patients, 15 patients (83.33%) lost weight. Eleven patients (61.11%)
lost about six pounds. The highest loss was nine pounds. Four patients lost one to two
pounds, and two patients maintained their starting weight. One patient gained 17 pounds.
This patient was found not to comply with the regimen that was requested, and indeed
increased caloric consumption over the four weeks.
It is significant that patients with a higher BMI lost more weight. Thirteen out of
18 patients (72.22%) reduced their waist by 0.5 inches to 3 inches. Five out of 18
patients (27.77%) felt an increase in energy while on the active substance. Three out of
six placebo patients (50%) gained one pound and one placebo patients lost one pound.
The only adverse effects that occurred were in two patients (a husband and wife),
one of whom was on active substance and the other (male) on placebo. They complained
of acidity and a bloating sensation soon after starting the capsules. Both of them stopped
taking the capsules, then started again and claimed they developed the same symptoms.
Therefore, they both discontinued taking the capsules altogether.
 CONCLUSIONS

From this preliminary American study of the herb, Carulluma fimbriata, used in a
weight reduction program (with no change in daily activity patterns or change in diet),
resulted in a statistically significant weight loss over a period of only four weeks. Further
studies of this interesting succulent are recommended, since there are few, if any, over-
the-counter (non-prescription), natural substances which can produce such an effect at
this time. Of great significance is the lack of toxicity and the lack of side effects
produced by Carulluma fimbriata. This was noted on the original Indian study of 62
patients and is verified by us at the time of this study.

REFERENCES

1. National Task Force on the Prevention and Treatment of Obesity.

Overweight, obesity, and health risk. Arch Intern Med. 2000;1 60:898-
904.
2. Must A, Spadano J, Coakley E. et al. The disease burden associated
with overweight and obesity. JAMA. 1999;282:1523-1529.
3. Allison DB, Fontaine KR, Manson JE, et al. Annual deaths attributable
to obesity in the United States. JAMA. 1999;282:1530-1538.
4. Cummings S, Parham ES, Strain GW. Position of the American
Dietetic Association: Weight management. J Am Diet Assoc.
2002;102:1145-1155.
5. Wealth of India, Volume 3, (Ca-Ci), pg 266/267.
6. Caralluma http://www.botany.com/index.html
7. Famine Foods
http://www.hort.purdue.edu/newcrop/FamineFoods/ff_home. html
 SLIMALUMA® Second Clinical Study:
Average Reduction

4.0

3.5

3.0

2.5

2.0

1.5

1.0

0.5

0.0

-0.5
BMI Weight (lb) Waist (In)
Active 0.56 3.47 0.91
Placebo -0.04 0.2 0
 SLIMALUMA® Second Clinical Study:
Average Reduction in Waist Circumference

43.00

42.50

42.00

41.50

41.00
Inches

40.50

40.00

39.50

39.00

38.50
Slimaluma Placebo
Before 42.74 40.14
After 41.83 40.14
 Why ?
• Unique standardized Appetite Suppressant and Fat Reducer

• Efficacy proven by two Human Clinical Trials

• Proven safe by 6 Safety Studies

• Convenient dosage of 500 mg twice a day

• 99% Water Soluble and stable at 250ºF

• GRAS (Generally Recognized As Safe)

• US Patents 7,060,308 and 7,390,516

• Kosher and Halal certified

• Certified Organic

• Meets DSHEA requirement under section 413(a)(1)

• Consistent quality and supply directly from originators: GENCOR