NCT01753674

The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Connecticut · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and plasma glucose in individuals classified with metabolic syndrome.

Detailed description

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.

Conditions

• Metabolic Syndrome
• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	TA-65	TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
DIETARY_SUPPLEMENT	Placebo	Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2012-12-20
• Last updated: 2015-05-28

Locations

1 site across 1 country: United States