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

This study is currently recruiting participants.
Verified February 2014 by University of Connecticut
Sponsor:
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01753674
First received: December 17, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Metabolic Syndrome
Insulin Resistance
Dietary Supplement: TA-65
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • Plasma insulin levels [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    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:
  • plasma HDL cholesterol [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome


Other Outcome Measures:
  • blood pressure [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
    It is expected that the supplement will decrease blood pressure, another outcome of metabolic syndrome


Estimated Enrollment: 45
Study Start Date: January 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: TA-65
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

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753674

Locations
United States, Connecticut
University of Connecticut Recruiting
Storrs, Connecticut, United States, 06269
Contact: Maria-Luz Fernandez, Phd    860-486-5547    maria-luz.fernandez@uconn.edu   
Contact: Jeff Volek, PhD    860-486-6712    jeff.volek@uconn.edu   
Principal Investigator: Maria Luz Fernandez, PhD         
Sub-Investigator: Ock Chun, PhD         
Sub-Investigator: Jeff S Volek, PhD, RD         
Sponsors and Collaborators
University of Connecticut
Investigators
Principal Investigator: Maria-Luz Fernandez, Ph.D. University of Connecticut
  More Information

Additional Information:
Publications:
Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT01753674     History of Changes
Other Study ID Numbers: H12-256, TAS-12-035
Study First Received: December 17, 2012
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 17, 2014