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

• ClinicalTrials.gov Identifier: NCT02531334
• Recruitment Status: Completed
• First Posted: August 24, 2015
• Last Update Posted: October 10, 2018
• Sponsor: University of Connecticut
• Information provided by (Responsible Party): Maria Luz Fernandez, University of Connecticut

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome X	Dietary Supplement: TA-65	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of TA-65, a Telomerase Activator on Metabolic Syndrome
• Study Start Date: August 2015
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: June 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: TA-65; TA-65 will be provided to volunteers for 12 weeks, two pills per day of 8 mg each	Dietary Supplement: TA-65; 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.
Placebo Comparator: Placebo; Placebo will be provided to volunteers for 12 weeks, two pills per day of 8 mg each	Dietary Supplement: TA-65; 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.

Outcome Measures

Primary Outcome Measures :

1. Plasma insulin [ Time Frame: 27 weeks ]
   The supplement is expected to decrease insulin resistance in metabolic syndrome patients

Secondary Outcome Measures :

1. Plasma HDL cholesterol [ Time Frame: 27 weeks ]
   The supplement is expected to increase plasma HDL cholesterol

Other Outcome Measures:

1. Blood pressure [ Time Frame: 27 weeks ]
   The supplement is expected to decrease blood pressure

Eligibility Criteria

• Ages Eligible for Study: 32 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Connecticut

University of Connecticut

Storrs, Connecticut, United States, 06269

Sponsors and Collaborators

University of Connecticut

Investigators

• Principal Investigator: Maria Luz Fernandez, PhD; University of Connecticut

More Information

Publications of Results:

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.

• Responsible Party: Maria Luz Fernandez, Professor, University of Connecticut
• ClinicalTrials.gov Identifier: NCT02531334
• Other Study ID Numbers: H14-278
• First Posted: August 24, 2015
• Last Update Posted: October 10, 2018
• Last Verified: October 2018

Additional relevant MeSH terms:

Metabolic Syndrome; Syndrome; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases