Human Consent Form

The Effect of Diet on Indicators of Metabolic Syndrome

Libby Terrell (Student Researcher)

I am asking for your voluntary participation in my science fair project. Please read the following information about
the project. If you would like to participate, please sign in the appropriate area below.

Introduction
The purpose of this study is to investigate the effect of replacing carbohydrate with saturated fatty acids,
monounsaturated fatty acids, and omega-3 polyunsaturated fatty acids. Triglycerides and body mass index will be
measured as indicators of risk of developing diseases associated with Metabolic Syndrome.

Participant Expectations
All participants will undergo two testing sessions and complete a total of five 24-hour dietary recall surveys. Testing
will involve measuring body mass index and fasting whole-blood triglyceride levels, the latter of which requires a
fingerstick. Each testing session will take around ten minutes to complete. Participants will also be asked to
complete a demographics survey. Dietary recall surveys will be completed using ASA-24 software provided by the
National Cancer Institute. Each recall survey will take between 10-15 minutes to complete.
Participants in the experimental group will be asked to adopt a low-carbohydrate diet for 28 days.

Potential Risks
The diet being tested does not follow the 2015-2020 Dietary Guidelines for Americans. Epidemiological evidence
has shown association of dietary saturated fat with heart disease; therefore, it is possible that increased saturated fat
intake could increase risk of developing heart disease. However, the causative role of saturated fat on heart disease
has not been proven through clinical trials.
The Cardiochek PA Analyzer uses a fingerstick to measure whole blood triglyceride levels. The device has been
declared substantially equivalent by the FDA for multi-patient use. The fingerstick may be a source of discomfort
for participants. The registered school nurse will be performing the procedure; standard medical procedures will be
followed to reduce risks associated with fingersticking.

Benefits
Participants adopting the diet are hypothesized to see reductions in triglyceride levels and/or body mass index
indicating reduced risk of developing diseases associated with Metabolic Syndrome.
Data collected in this study will contribute to nutritional research.

Confidentiality
Triglyceride and body mass index measurements, as well as dietary recall survey data, will be recorded under
participants’ identification numbers; identification numbers will not be reported in the final publication.

Voluntary Participation:
Participation in this study is completely voluntary. If you decide not to participate there will not be any negative
consequences. Please be aware that if you decide to participate, you may stop participating at any time and you may
decide not to answer any specific question.

If you have any questions about this study, feel free to contact:
Researcher: Libby Terrell Phone/email: (434)326-7111 egtn6@k12albemarle.org
Adult Sponsor/QS/DS: Carol Stutzman Phone/email: (434)882-4248 cstutzman@k12albemarle.org
By signing this form, I agree with the following statements.

I have read and understand the information above and I freely give my consent/assent to participate.

I do not have cardiovascular disease, diabetes, prediabetes, hypertension, cancer, endothelial dysfunction,
or any other disease that would put me at risk when dieting.

I do not take statins, blood pressure medication, endothelial function medication, or any other medication
that would interfere with my triglyceride or weight measurements.

I am not pregnant or lactating.

I am aware that fingersticking before and after the 28-day experimental period is necessary to take part in
this study.

Date Reviewed & Signed:___________________________

________________________________________________ __________________________________________
Research Participant Printed Name Signature