TA-65 and Aging Associated Microvascular Dysfunction

Aging Clinical Trial

Official title:

TA-65 and Aging Associated Microvascular Dysfunction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05598359
• Other study ID #: TA-65 and Vascular Aging
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2029

Study information

• Verified date: October 2023
• Source: Medical College of Wisconsin
• Contact: Andreas Beyer, Ph.D.
• Phone: 414-955-7514
• Email: abeyer[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Telomere Shortening
• Vascular Diseases

Intervention

Dietary Supplement:
• TA-65
TA-65 is a purified small molecule extracted from Astragalus root

Other:
• Placebo
Inactive formulation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Penn State University, University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Systemic Blood Pressure	Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff	28 days