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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

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 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


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.




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



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:

  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

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

Publications of Results:
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