The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
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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 |
- 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
- 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
- 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: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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), Thiazolidenediones (Avandia, ACTOS,), Meglitinides (Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose, Glyset), 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| United States, Connecticut | |
| University of Connecticut | Not yet 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 | |
| Principal Investigator: | Maria-Luz Fernandez, Ph.D. | University of Connecticut |
More Information
Additional Information:
No publications provided
| 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: | January 15, 2013 |
| 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 May 16, 2013