Effects of TA-65, a Telomerase Activator on Metabolic Syndrome

Not Applicable

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Dietary Supplement: TA-65

• Registration Number: NCT02531334
• Lead Sponsor: University of Connecticut

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-21
• Study First Posted: 2015-08-24
• Primary Completion: 2017-12
• Study Completion: 2018-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 32 to 70 years

2. Men and women

3. Proficiency in English

4. Postmenopausal women, or women of childbearing age (premenopausal) must be using some form of contraception or have had a hysterectomy

5. Classification of metabolic syndrome according to the Adult treatment panel (ATP) III criteria, meaning that individuals have 3 or more of the following characteristics:

   • Waist circumference >102 cm for men or > 88 cm for women
   • Triglycerides > 150 mg/d L
   • HDL cholesterol < 40 mg/dL for men or < 50 mg/dL for women
   • Blood pressure > 130/85 mm Hg or systolic ≥ 130 or diastolic ≥ 85*
   • Fasting blood glucose > 100 mg/dL *Or taking blood pressure medications

Exclusion Criteria

1. Participants who do not fulfill the classification of metabolic syndrome, which means that they do not have 3 or more of the 5 characteristics previously mentioned
2. Participants with a body mass index (BMI) > 40 kg/m2
3. Current or past diagnosis of liver disease, renal disease, diabetes, cancer, stroke, heart disease, severe infectious disease, or autoimmune diseases (including but not limited to multiple sclerosis, lupus, and rheumatoid arthritis)
4. Women who are pregnant, lactating, or planning to become pregnant
5. Use of any glucose-lowering prescriptions or supplements, such as Sulfonylureas (Glucotrol, Amaryl, chlorpropamide, gliclazide, glimepiride, glipizide, glyburide), Thiazolidinediones (Avandia, ACTOS, rosiglitazone, pioglitazone), Meglitinides (Prandin, Starlix), Biguanides (Metformin), Alpha-glucosidase inhibitors (Precose, Glyset, acarbose, miglitol), Dipeptidyl peptidase (DPP)-4 inhibitors (Januvia, Onglyza, alogliptin, linagliptin, saxagliptin, sitagliptin), Glucagon-like peptide (GLP-1) antagonists (exenatide, liraglutide), Meglitinides (nateglinide, repaglinide), sodium glucose cotransporter (SGLT)-2 inhibitors (canagliflozin) or high dose chromium or cinnamon supplements
6. Use of immunosuppressants, including azathioprine, cyclophosphamide, basiliximab, cyclosporine, everolimus, daclizumab, infliximab, mercaptopurine, methotrexate, muromonab-cluster of differentiation3 (CD3), mycophenolate, pimecrolimus, rituximab, tacrolimus, sirolimus, prednisone, methylprednisone, dexamethasone, hydrocortisone (not topical), or prednisolone
7. Use of anticoagulants, including factor Xa inhibitors (rivaroxaban, apixaban), thrombin inhibitor (dabigatran), vitamin K antagonist (warfarin), heparin, low-molecular weight heparin, fondaparinux, or antiplatelets (aspirin, cilostazol, clopidogrel, dipyridamole, prasugrel, ticagrelor, ticlopidine)
8. Use of other categories of drugs, including methadone, Suboxone, monoamine oxidase (MAO) inhibitors, or lithium.
9. Use of any combination drug product containing any of the individual drugs listed above
10. Participants who have been consistently taking vitamin, mineral, or multivitamin supplements prior to recruitment may be admitted into the study if they plan to maintain their current supplement program. However, subjects may not participate if they begin taking a new supplement during the 27-week study period.
11. Fasting plasma triglycerides ≥ 500 mg/dL, glucose ≥ 126 mg/dL, or blood pressure > 145/100 mm Hg or systolic > 145 mm Hg or diastolic > 100 mm Hg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TA-65	TA-65	TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each
Placebo	TA-65	Placebo will be provided to volunteers for 12 weeks, two pills per day of 8 mg each

Primary Outcome Measures

Name	Time	Method
Plasma insulin	27 weeks	The supplement is expected to decrease insulin resistance in metabolic syndrome patients

Secondary Outcome Measures

Name	Time	Method
Plasma HDL cholesterol	27 weeks	The supplement is expected to increase plasma HDL cholesterol

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States