The Effects of the Telomerase Activator TA-65 on Insulin Resistance, Inflammation, and Metabolic Syndrome
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Metabolic Syndrome, Insulin Resistance
In brief
Our hypothesis is that TA-65, a dietary supplement will help to reduce insulin resistance and plasma glucose in individuals classified with metabolic syndrome.
Key facts
- Study ID
- NCT01753674
- Run by
- University of Connecticut
- People needed
- 13
- Starts
- 2013-01-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2015-05-28
Who can join
Age: 35 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Connecticut — Storrs, Connecticut, United States
Full record on ClinicalTrials.gov
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