TA-65 and Aging Associated Microvascular Dysfunction

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

Study Overview

• Status: Not yet recruiting
• Conditions: Vascular Diseases; Aging; Telomere Shortening
• Intervention / Treatment: Dietary supplement: TA-65; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andreas Beyer, Ph.D.; Phone Number: 414-955-7514; Email: abeyer@mcw.edu
• Study Contact Backup: Name: William Hughes, Ph.D.; Phone Number: 414-955-7519; Email: whughes@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Penn State University; University of Louisville
• Investigators: Principal Investigator: Andreas Beyer, Ph.D., Associate Professor

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: TA-65 and Vascular Aging

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data available upon record completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No