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

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ClinicalTrials.gov Identifier: NCT02531334

Recruitment Status : Active, not recruiting

First Posted : August 24, 2015

Last Update Posted : February 8, 2018

Sponsor:

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
Estimated Study Completion Date :	June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Metabolic Syndrome

Genetic and Rare Diseases Information Center resources: Abdominal Obesity Metabolic Syndrome

U.S. FDA Resources

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.

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

Information from the National Library of Medicine

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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531334

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 History of Changes
Other Study ID Numbers:	H14-278
First Posted:	August 24, 2015 Key Record Dates
Last Update Posted:	February 8, 2018
Last Verified:	February 2018

Additional relevant MeSH terms:


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

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