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

NCT ID: NCT01753674

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TA-65

TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each

Group Type: EXPERIMENTAL

TA-65

Intervention Type: DIETARY_SUPPLEMENT

TA-65 will be provided to volunteers, 2 pills per day of 8 mg each

Placebo

Placebo will be provided to volunteers for 12 weeks, 2 pills per day of 8 mg each.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each

Interventions

TA-65

TA-65 will be provided to volunteers, 2 pills per day of 8 mg each

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria-Luz Fernandez, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20383691 (View on PubMed)

Related Links

http://www.tasciences.com/

Sponsor Company

Other Identifiers

TAS-12-035

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H12-256

Identifier Type: -

Identifier Source: org_study_id