TA-65 and Aging Associated Microvascular Dysfunction

Sponsor

Medical College of Wisconsin (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05598359

Collaborator

Andreas Beyer, Ph.D. (Other)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Telomere Shortening Aging Vascular Diseases	Dietary Supplement: TA-65 Other: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

TA-65 and Aging Associated Microvascular Dysfunction

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2029

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Systemic Blood Pressure [28 days]
Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Young Control

Participants must be between 18-55 yrs. of age
Less than 3 cardiovascular risk factors

Older Subjects

Participants must be between 56+ yrs. of age
Less than 3 cardiovascular risk factors

Coronary Artery Disease (CAD) Subjects

Participants must be 18+ yrs. of age
Participants have clinically diagnosed CAD

Exclusion Criteria:

Self-reported habitual vigorous exercise (>20 min, 3 times per week, 1 yr)
Cardiovascular events in the last year (heart attack, stroke, etc)
Heart Failure
Renal Impairment
Cardiovascular Risk Factors (young and older only)
Uncontrolled hypertension
Current Tobacco use or within last 6 months
Body Mass Index > 35
Hyperlipidemia
Hypercholesterolemia
Type 1 or Type 2 Diabetes
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
Documented neuromuscular disorders
Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
Pregnancy (Young Female subjects)
Active anti-cancer treatment or treatment within last 12 months
Active COVID-19 or within the past 3 months
Gender Reassignment Therapy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical College of Wisconsin
Andreas Beyer, Ph.D.

Investigators

Principal Investigator: Andreas Beyer, Ph.D., Associate Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William Hughes, Postdoc Fellow, Medical College of Wisconsin

ClinicalTrials.gov Identifier:

NCT05598359

Other Study ID Numbers:

TA-65 and Vascular Aging

First Posted:

Oct 28, 2022

Last Update Posted:

Oct 28, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Oct 28, 2022