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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01753674
• Other study ID #: H12-256
• Secondary ID: TAS-12-035
• Status: Terminated
• Phase: Phase 1
• First received: December 17, 2012
• Last updated: May 27, 2015
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: University of Connecticut
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• TA-65
TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
• Placebo
Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each

Locations

Country	Name	City	State
United States	University of Connecticut	Storrs	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	blood pressure	It is expected that the supplement will decrease blood pressure, another outcome of metabolic syndrome	27 weeks	No
Primary	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	No
Secondary	plasma HDL cholesterol	It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome	27 weeks	No

External Links

•   Sponsor Company