Metabolic Syndrome Clinical Trial
Official title:
The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and plasma glucose in individuals classified with metabolic syndrome.
This is double blind cross over randomized clinical trial. The supplement and placebo will
be provided by TA Science, Inc. and prepared as described below. Subjects will be randomly
allocated to consume either a daily serving of TA-65 (two capsules per day of 8 mg each)
(please see attached label) or a placebo for 12 weeks. Randomization will be done in a
sequential manner; the first subject will be allocated to supplement A and the next one to
supplement B and so on. After a 3-week washout, they will be allocated to the alternate
treatment for additional 12 weeks. Supplements (TA-65 or placebo) will be taken twice daily
with a meal.
Participants will be advised not to change their diet or exercise protocols during the 27
week intervention. Volunteers will be required to provide a 5-day dietary record before
starting the study, at the end of each supplement period (TA-65 or placebo) and at the end
of the washout period. Subjects will have to fill an exercise questionnaire during the same
times to ensure that there are no changes in physical activity. Participants will be asked
to report to the department every 4 weeks for checking compliance on supplement intake and
to assess weight and blood pressure.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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