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.

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome; Insulin Resistance
• Intervention / Treatment: Dietary supplement: TA-65; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The inclusion criteria are:

men and women (40-70 y) with metabolic syndrome which means having at least 3 of the following characteristics:

• Blood pressure > 130/85 mm Hg
• plasma glucose > 100 mg/dL
• plasma triglycerides > 150 mg/dL
• HDL cholesterol < 40 mg/dL (men) and < 50 mg/dL (women)
• waist circumference >102 cm (men) and ≥ 88 cm (women)
• Women of childbearing age should be using contraception

Exclusion Criteria:

Exclusion criteria will be

• self-reported diabetes mellitus
• coronary heart disease
• triglycerides greater than 400 mg/dL
• Fasting glucose greater than 126 mg/dL
• Blood pressure greater than 140/100 mmg Hg
• history of stroke
• Use of alcohol at an elevated rate (more than two drinks per day)
• Renal problems
• liver disease
• cancer
• pregnancy and lactation
• severe infectious diseases
• autoimmune disease currently under treatment
• current hormone therapy
• previous treatment with TA-65.
• Intake of glucose-lowering prescriptions
• Use of immunosuppressants, lithium or supplements such as Sulphonylureas (Glucotrol, Amaryl), Thiazolidinedione (Avandia, ACTOS,), Meglitinides (Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose, Glyset), dipeptidyl peptidase (DPP)-4 inhibitors (Januvia, Onglyza)
• high dose chromium or cinnamon supplements
• Consistent intake of vitamin, mineral, or multivitamin supplements prior to recruitment may be admitted into the study if they plan on maintaining their current supplement program.

However, subjects may not participate if they begin taking a new supplement during the 27-wk study period.

-Subjects will also be asked to refrain from taking any additional supplements, including fish oil, herb and concentrated antioxidant sources.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TA-65; TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each	Dietary supplement: TA-65; TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
Placebo Comparator: Placebo; Placebo will be provided to volunteers for 12 weeks, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma insulin levels	The supplement is anticipated to decrease insulin resistance in individuals with metabolic syndrome. The investigators will measure plasma insulin and plasma glucose as outcomes measures	27 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasma HDL cholesterol	It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome	27 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	It is expected that the supplement will decrease blood pressure, another outcome of metabolic syndrome	27 weeks

Collaborators and Investigators

• Sponsor: University of Connecticut
• Investigators: Principal Investigator: Maria-Luz Fernandez, Ph.D., University of Connecticut

Publications and helpful links

General Publications

• Maubaret CG, Salpea KD, Jain A, Cooper JA, Hamsten A, Sanders J, Montgomery H, Neil A, Nair D, Humphries SE; HIFMECH consortium, Simon Broome Research Group. Telomeres are shorter in myocardial infarction patients compared to healthy subjects: correlation with environmental risk factors. J Mol Med (Berl). 2010 Aug;88(8):785-94. doi: 10.1007/s00109-010-0624-3. Epub 2010 Apr 11.

Helpful Links

• Sponsor Company

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: metabolic syndrome, insulin resistance, HDL cholesterol,
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Hyperinsulinism; Syndrome; Inflammation; Metabolic Syndrome; Insulin Resistance
• Other Study ID Numbers: H12-256; TAS-12-035 (Other Grant/Funding Number: TA Sciences Inc)