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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01753674
Recruitment Status : Terminated (non-compliance issues)
First Posted : December 20, 2012
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
University of Connecticut

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Insulin Resistance Dietary Supplement: TA-65 Dietary Supplement: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
Study Start Date : January 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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

Primary Outcome Measures :
  1. Plasma insulin levels [ Time Frame: 27 weeks ]
    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

Secondary Outcome Measures :
  1. plasma HDL cholesterol [ Time Frame: 27 weeks ]
    It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome

Other Outcome Measures:
  1. blood pressure [ Time Frame: 27 weeks ]
    It is expected that the supplement will decrease blood pressure, another outcome of metabolic syndrome

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01753674

United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
Sponsors and Collaborators
University of Connecticut
Principal Investigator: Maria-Luz Fernandez, Ph.D. University of Connecticut

Additional Information:
Responsible Party: University of Connecticut Identifier: NCT01753674     History of Changes
Other Study ID Numbers: H12-256
TAS-12-035 ( Other Grant/Funding Number: TA Sciences Inc )
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by University of Connecticut:
metabolic syndrome, insulin resistance, HDL cholesterol,

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs