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Not recruiting
Phase 1
Phase 2

Fisetin

Sponsor:

University of Colorado, Boulder

Code:

NCT06133634

Conditions

Aging

Endothelial Dysfunction

Arterial Stiffness

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

Fisetin

Placebo

Study Details

Brief summary:

This is a pilot clinical trial to test the efficacy of intermittent treatment with the flavonoid compound fisetin for improving vascular endothelial function and reducing aortic stiffness in older adults. This trial will also determine the potential mechanisms by which fisetin may improve vascular function, including by decreasing mitochondrial oxidative stress, cellular senescence and senescence-associated secretory phenotype (SASP) factors in circulation. Lastly, safety, tolerability and adherence of fisetin treatment will be assessed.

Conditions

Aging

Endothelial Dysfunction

Arterial Stiffness

Study ID

NCT06133634

Start date

Sep 25, 2023

Status verified date

Dec, 2024

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 65 years or older
  • Women must be postmenopausal
  • Body mass index (BMI) <40 kg/m2
  • Willing to accept random assignment
  • Weight stable in the prior 2 months (<2 kg weight change) and willing to remain weight stable throughout the study
  • Ability to understand study procedures and to comply with them for the entire length of the study
  • No blood donation within 8 weeks prior to baseline testing; willingness to abstain from blood donation during the study and for 8 weeks after study completion
  • Absence of established, serious, unstable, chronic clinical disease (e.g., unstable CVD) as determined by study physician of record based on subject medical history, physical examination, resting ECG and standard clinical blood chemistries

Exclusion Criteria:

  • Inability to refrain from alcohol for 24 hours prior to outcome assessment
  • Individuals taking fisetin, quercetin, luteolin, Dasatinib, piperlongumine or Navitoclax (supplements or drugs with established senolytic effects) within 6 months prior to baseline testing; should new research reveal other dietary supplements or drugs with potential senolytic effects, their use will be evaluated, and their use may lead to exclusion of the subject by the PI
  • New use of regular cardiovascular-acting medication which, in the opinion of the PI, affects the outcomes of the study within 3 months prior to starting baseline testing as reported during medication review during screening (these individuals could be enrolled after 3 months of regular use)
  • Chronic use of a dietary supplement which, in the opinion of the PI, affects the outcomes of the study, within 1 month prior to starting baseline testing as reported during medication review during screening (these individuals could be enrolled after 1 month of regular use)
  • Active malignancy (including myeloma) or malignancy that was active within 5 years prior to baseline testing
  • Inability or unwillingness of individual to give written informed consent
  • Current or past participation within 3 months in another clinical trial that, in the opinion of the PI, would affect the outcomes of the study
  • Known hypersensitivity or allergy to fisetin
  • Blood donation within 2 months prior to baseline testing
  • Resting blood pressure >160 mmHg systolic or >110 mmHg diastolic
  • Regular vigorous aerobic/endurance exercise

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Fisetin

Fisetin will be administered in an intermittent manner with two, three-day dosing periods at a dose of 2 mg/kg/day separated by two weeks.

placebo comparator: Placebo

Placebo capsules identical in appearance to fistin capsules will be administered in an intermittent manner with two, three-day dosing periods separated by two weeks.

Interventions

Fisetin

Fisetin dietary supplement

Placebo

Placebo capsules identical in appearance to fisetin capsules

Primary outcome measure

  • Change from baseline in endothelial function at 1 month [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Sarah Haydu, MA

303-735-6410fisetinstudy@colorado.edu

Locations

University of Colorado Boulder

Recruiting

Boulder, Colorado, United States, 80305

Contacts

Sarah Haydu, MA

303-735-6410fisetinstudy@colorado.edu

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Mar 27, 2025

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2025-03-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.