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TA-65 and Aging Associated Microvascular Dysfunction

Primary Purpose

Telomere Shortening, Aging, Vascular Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TA-65
Placebo
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Telomere Shortening

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    TA-65

    Placebo

    Arm Description

    TA-65 (250 U) taken once per day

    Placebo taken once per day

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 18, 2022
    Last Updated
    March 16, 2023
    Sponsor
    Medical College of Wisconsin
    Collaborators
    University of Louisville, Penn State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05598359
    Brief Title
    TA-65 and Aging Associated Microvascular Dysfunction
    Official Title
    TA-65 and Aging Associated Microvascular Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2028 (Anticipated)
    Study Completion Date
    December 31, 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical College of Wisconsin
    Collaborators
    University of Louisville, Penn State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telomere Shortening, Aging, Vascular Diseases

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TA-65
    Arm Type
    Experimental
    Arm Description
    TA-65 (250 U) taken once per day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo taken once per day
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    TA-65
    Intervention Description
    TA-65 is a purified small molecule extracted from Astragalus root
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Inactive formulation
    Primary Outcome Measure Information:
    Title
    Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis
    Description
    Cutaneous microvascular function measured via laser Doppler flowmetry coupled with intradermal microdialysis of non-specific nitric oxide synthase inhibitor, L-NAME
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    Systemic Blood Pressure
    Description
    Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff
    Time Frame
    28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andreas Beyer, Ph.D.
    Phone
    414-955-7514
    Email
    abeyer@mcw.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    William Hughes, Ph.D.
    Phone
    414-955-7519
    Email
    whughes@mcw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andreas Beyer, Ph.D.
    Organizational Affiliation
    Associate Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    Data available upon record completion

    Learn more about this trial

    TA-65 and Aging Associated Microvascular Dysfunction

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