NCT05598359

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Jan 2027

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
4.2 years until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

October 18, 2022

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Systemic Blood Pressure

    28 days

Study Arms (2)

TA-65

EXPERIMENTAL

TA-65 (250 U) taken once per day

Dietary Supplement: TA-65

Placebo

PLACEBO COMPARATOR

Placebo taken once per day

Other: Placebo

Interventions

TA-65DIETARY_SUPPLEMENT

TA-65 is a purified small molecule extracted from Astragalus root

TA-65
PlaceboOTHER

Inactive formulation

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Adults 18 - 35 and 65+ years of age
  • Subjects with clinical diagnosis of CAD

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Andreas Beyer, Ph.D.

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Beyer, Ph.D.

CONTACT

William Hughes, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoc Fellow

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 28, 2022

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data available upon record completion