TA-65 and Aging Associated Microvascular Dysfunction

Medical College of Wisconsin

Status: Not yet enrolling

Conditions: Aging; Telomere Shortening; Vascular Diseases

Treatments: Other: Placebo; Dietary Supplement: TA-65

Study type: Interventional

Funder types: Other

Identifiers

NCT05598359

TA-65 and Vascular Aging

Details and patient eligibility

About

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

Full 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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

TA-65

Experimental group

Description:

TA-65 (250 U) taken once per day

Treatment:

Dietary Supplement: TA-65

Placebo

Placebo Comparator group

Description:

Placebo taken once per day

Treatment:

Other: Placebo