effect of a product on ambulatory blood pressure (ABP), in 60 individuals with pre-hypertension (or alternatively, mild hypertension). Population 60 pre-hypertensive adults Inclusion criteria: To be determined during protocol development Male or female age 30-75 Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result Healthy otherwise as determined by laboratory results and medical history Systolic blood pressure 120-140 mmHg at screening and baseline Diastolic blood pressure 80-90 mmHg at screening and baseline Has given voluntary, written, informed consent to participate in the study Exclusion criteria: To be determined during protocol development Woman who is pregnant, breastfeeding, or planning to become pregnant during the course of the trial Alcohol use >2 standard alcoholic drinks per day Significant cardiac history defined as a history of myocardial infarction (MI); coronary angioplasty or bypass graft(s); valvular disease or repair; unstable angina pectoris; transient ischemic attack (TIA); cerebrovascular accidents (CVA); congestive heart failure; or coronary artery disease (CAD) Uncontrolled hypertension defined as untreated systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg and/or taking medication for the treatment of hypertension Diabetes (Type I or Type II) History of renal and/or liver disease History of alcohol or drug abuse within the past year Unstable psychiatric disorder Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV) Participation in a clinical research trial within 30 days prior to randomization Use of natural health products other than vitamins or minerals within 4 weeks prior to randomization and during the course of the study Significant abnormal liver function as defined as AST and/or ALT > 2 x the upper limit of normal (ULN), and/or bilirubin > 2 x the ULN Serum creatinine > 130 umol/L for males and > 125 umol/L for females
2 Anemia of any etiology defined as hemoglobin < 120 g/L for males and < 110 g/L for females Uncontrolled and/or untreated thyroid disorder Use of anticoagulants, statins, or any other medication for the treatment of hypercholesterolemia Use of prescribed medication or over the counter supplements for weight loss Allergy or sensitivity to study supplement ingredients Individuals who are cognitively impaired and/or who are unable to give informed consent. Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject Test Products Test Product Placebo Design This will be 12-week intervention period. The screening process will consist of determining eligibility based on the inclusion and exclusion criteria. At screening (visit 1,day-7), fasting peripheral blood will be taken to determine CBC count, electrolytes (Na, K, Cl), glucose, insulin, BUN, creatinine, cystatin-C, AST, ALT, GGT, bilirubin, total cholesterol, HDL, LDL, and triglycerides. Medical history and concomitant therapies will be reviewed; height, weight, heart rate, and resting blood pressure will be measured. Eligible subjects will be given an ambulatory blood pressure monitor for 24-hour blood pressure monitoring to be returned at each visit. A 3-day food record and daily activity dairy will be dispensed. At visit 2 (day 0), eligible subjects will be randomized in two groups of 30. One group will be taking the product and the other group will be taking placebo for 12 weeks period. Fasting blood will be collected and food records and activity diary will be reviewed; 24hour blood pressure data will be collected; concomitant therapies will be reviewed; weight, heart rate, and resting blood pressure will be measured. Subjects retain the ambulatory blood pressure monitor to be used throughout the study. Subjects will return for clinic at visits 3(day7), 4 (day 14), 5(day 21). Food records and activity diary will be reviewed; 24-hour blood pressure data will be collected; concomitant therapies and adverse events will be reviewed; weight, heart rate, and resting blood pressure will be measured. At visit 6 (day 28), fasting blood will be collected to determine final CBC count, electrolytes (Na, K, Cl), glucose, insulin, BUN, creatinine, cystatin-C, AST, ALT, GGT, bilirubin, total cholesterol, HDL, LDL, and triglycerides. Food records and activity diary will be reviewed; 24-hour blood pressure data will be collected; concomitant therapies and adverse events will be reviewed; weight, heart rate, and resting blood pressure will be measured. Study Proposal Prepared for Arlen Nutraceuticals June 7, 2010 Confidential
Total number of subjects 60 (parallel design 30 subject taking the product and 30 on placebo) Duration of the Study Each subject will be followed for a study period of 12 weeks. Primary Endpoints Blood Pressure Secondary variables Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Confidential
Schedule of Procedures
Procedure/assessment Informed consent Review inclusion/exclusion criteria Review medical history Review concomitant therapies Height*, weight, heart rate, blood pressure *Height will only be measured at visit 1 Dispense 3-day food records and activity diary Review 3-day food records and activity diary Dispense ambulatory blood pressure monitor Collect ambulatory blood pressure monitor Urine pregnancy test Laboratory tests: CBC count, electrolytes (Na, K, Cl), glucose, insulin, BUN, creatinine, AST, ALT, GGT, bilirubin, cystatin-C, total cholesterol, HDL, LDL, triglycerides, Randomization Dispense test product Collect test product
Visit 3 Day 7
Visit 4 Day 14
Visit 5 Day 21
Visit 6 Day 28 X X X
X X X X X X X
X X X X X X X
X X X X X X X
X X
X X X X
X X
X X Confidential
Confidential
N= 60
Study Preparation Fees: Protocol Development & REB Approval Upfront Project Management: Total: Interim Study Fees: Subject Recruiting Total: Per Subject Fee: Subject Conduct Fee Total: $936 $56,200 $4,000 $4,000 $8,000 $3,000 $11,000
$10,000 $81,200
1,624 82,824
Budget Details N=30 Per Subject Fee: Evaluations Physician Technical Personnel Blood chemistry and hematology Subject Reimbursement Clinical Trial Insurance Subtotal
Screen 30.00
Visit 3 30.00
Visit 4 30.00
Visit 5 30.00
50.00 25.00
725 + 75 = 800
$ 50.00 $ 25.00