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This study is being conducted to evaluate the efficacy of TA-65, a purified extract of Astragalus root, on insulin resistance, oxidative stress, and inflammation in individuals classified with metabolic syndrome.
Short telomeres are strongly linked to increased risk of cardiovascular disease and diabetes, indications where tissue aging and senescence play significant roles. Shorter leukocyte telomere length has been linked to impaired glucose tolerance, Type 2 Diabetes, and coronary heart disease. Telomere length and telomerase activity have been shown to be significantly lower in CAD patients. Telomere length may play an important role in predicting cardiovascular disease and diabetes. TA-65 may not only ameliorate the symptoms associated with these disease states, but be a preventive measure as well.
In this study, the researchers will investigate whether telomerase activator (TA)-65 can also improve the metabolic dysregulations associated with metabolic syndrome including oxidative stress, inflammation, high blood pressure and dyslipidemias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TA-65 | Experimental | TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each |
|
| Placebo | Placebo Comparator | Placebo will be provided to volunteers for 12 weeks, two pills per day of 8 mg each |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TA-65 | Dietary Supplement | 2 pills of TA-65 or placebo daily for 12 weeks. Subjects will be monitored weekly for side effects and every 4 weeks for compliance and safety monitoring. The whole intervention is a randomized double blind study for a duration of 27 weeks; 12 weeks for TA-65 or placebo allocated randomly and after a 3 week washout period, allocation to the alternate supplement TA-65 or placebo. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma insulin | The supplement is expected to decrease insulin resistance in metabolic syndrome patients | 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma HDL cholesterol | The supplement is expected to increase plasma HDL cholesterol | 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | The supplement is expected to decrease blood pressure | 27 weeks |
Inclusion Criteria:
Age 32 to 70 years
Men and women
Proficiency in English
Postmenopausal women, or women of childbearing age (premenopausal) must be using some form of contraception or have had a hysterectomy
Classification of metabolic syndrome according to the Adult treatment panel (ATP) III criteria, meaning that individuals have 3 or more of the following characteristics:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Luz Fernandez, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20383691 | Result | Maubaret CG, Salpea KD, Jain A, Cooper JA, Hamsten A, Sanders J, Montgomery H, Neil A, Nair D, Humphries SE; HIFMECH consortium, Simon Broome Research Group. Telomeres are shorter in myocardial infarction patients compared to healthy subjects: correlation with environmental risk factors. J Mol Med (Berl). 2010 Aug;88(8):785-94. doi: 10.1007/s00109-010-0624-3. Epub 2010 Apr 11. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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|
| D009750 |
| Nutritional and Metabolic Diseases |