TA-65 and Aging Associated Microvascular Dysfunction

Not Applicable

Not yet recruiting

• Conditions: Aging; Telomere Shortening; Vascular Diseases
• Interventions: Dietary Supplement: TA-65; Other: Placebo

• Registration Number: NCT05598359
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-28
• Study Start: 2026-01-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TA-65	TA-65	TA-65 (250 U) taken once per day
Placebo	Placebo	Placebo taken once per day

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Systemic Blood Pressure	28 days	Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff