Insulin Resistance, Metabolic Syndrome
Conditions
Keywords
metabolic syndrome, insulin resistance, HDL cholesterol,
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.
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.
Interventions
DIETARY_SUPPLEMENTTA-65
TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
DIETARY_SUPPLEMENTPlacebo
Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each
Sponsors
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma insulin levels | 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
| Measure | Time frame | Description |
|---|---|---|
| plasma HDL cholesterol | 27 weeks | It is expected that the TA-65 supplement will increase plasma HDL, another characteristic of metabolic syndrome |
Other
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | 27 weeks | It is expected that the supplement will decrease blood pressure, another outcome of metabolic syndrome |
Countries
United States
Outcome results
None listed