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

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Syndrome X

Intervention / Treatment
-----------------
* Dietary Supplement: TA-65


Participation Criteria
=================
Eligibility Criteria
-----------------
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: 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: 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 Participants with a body mass index (BMI) > 40 kg/m2 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) Women who are pregnant, lactating, or planning to become pregnant 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 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 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) Use of other categories of drugs, including methadone, Suboxone, monoamine oxidase (MAO) inhibitors, or lithium. Use of any combination drug product containing any of the individual drugs listed above 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. 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

Ages Eligible for Study
-----------------
Minimum Age: 32 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-65<br>TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each | Dietary Supplement: TA-65<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo will be provided to volunteers for 12 weeks, two pills per day of 8 mg each | Dietary Supplement: TA-65<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma insulin | The supplement is expected to decrease insulin resistance in metabolic syndrome patients | 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HDL cholesterol | The supplement is expected to increase plasma HDL cholesterol | 27 weeks |