TA-65 and Aging Associated Microvascular Dysfunction

Study Overview
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Brief Summary
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The goal of this clinical trial is to test whether activation of telomerase with a dietary supplement (TA-65) improves microvascular function.

Detailed Description
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The purpose of this clinical trial is to examine whether activation of autophagy with TA-65 which activates telomerase, improves microvascular function and blood pressure in an older population

Official Title
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TA-65 and Aging Associated Microvascular Dysfunction

Conditions
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Telomere Shortening, Aging, Vascular Diseases

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Adults 18 - 35 and 65+ years of age Subjects with clinical diagnosis of CAD Exclusion criteria will include: 36-64 years of age without clinical diagnosis of CAD Self-reported habitual vigorous exercise (>20 min, 3 times per week, 1 yr) Major Adverse Cardiovascular Event (MACE) in the last year (heart attack, stroke) Heart Failure Renal Impairment >3 Pre-existing Cardiovascular Risk Factors (healthy groups only) Type 1 or type 2 diabetes Uncontrolled hypertension Current tobacco use or within last 6 months BMI > 35 Hyperlipidemia Hypercholesterolemia Use of anti-coagulant drugs Use of anti-platelet drugs Erectile dysfunction medication in the past 6 months Use of topical/non-topical steroids in last 6 months Hormone replacement therapy (Post-Menopause or Gender Reassignment) History of retinopathy Documented neuromuscular disorders Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity) Pregnancy (young female subjects) Allergy to lidocaine Current diagnosis of cancer with or without active anti-cancer treatment (pharmaceuticals) or treatment within last 12 months Active COVID-19 or within the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-65<br>TA-65 (250 U) taken once per day | Dietary Supplement: TA-65<br>* TA-65 is a purified small molecule extracted from Astragalus root<br>|
| Placebo Comparator: Placebo<br>Placebo taken once per day | Other: Placebo<br>* Inactive formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis | Cutaneous microvascular function measured via laser Doppler flowmetry coupled with intradermal microdialysis of non-specific nitric oxide synthase inhibitor, L-NAME | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic Blood Pressure | Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff | 28 days |