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Not yet recruitingNCT07871162Updated Oct 15, 2026

Fisetin for Improving Vascular Function in Older Adults: A Phase II Clinical Trial

A Phase 2 interventional study of Fisetin and Placebo in Aging, Endothelial Dysfunction and Cellular Senescence, sponsored by University of Colorado, Boulder. Not yet recruiting at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by University of Colorado, Boulder · Phase 2, Interventional, and Treatment

Updated Oct 15, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Aging is associated with the development of vascular dysfunction, which increases the risk for cardiovascular disease. This clinical trial will assess if supplementation with the natural compound fisetin can improve vascular endothelial function in older adults. The clinical trial will also assess if any effects of fisetin on endothelial function are associated with reduced cellular senescence. The study will also evaluate safety, tolerability and adherence with fisetin treatment.

02

Conditions studied

  • Aging
  • Endothelial Dysfunction
  • Cellular Senescence
03

In context

Lead sponsor

University of Colorado, Boulder is the lead sponsor of 88 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Absence of established, serious, unstable, chronic clinical disease (e.g., unstable cardiovascular disease) that would make it unsafe for the individual to participate in the trial as determined by trial physician of record.

Exclusion criteria

Exclusion Criteria:

  • Inability to refrain from alcohol for 24 hours prior to outcome assessment, alcohol dependence or abuse
  • Individuals taking fisetin, quercetin, luteolin, Dasatinib, piperlongumine or Navitoclax (supplements or drugs with possible senolytic effects) within 6 months prior to baseline testing as reported during medication review during screening. 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 participant by the principal investigator (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 as reported during Medical History and Physical and/or on study screening forms
  • 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
  • Blood donation within 8 weeks prior to baseline testing; unwillingness to abstain from blood donation during the study and for 8 weeks after study completion
  • Resting blood pressure >160 mmHg systolic or >100 mmHg diastolic.
  • Regular vigorous aerobic/endurance exercise (>6 bouts/week at a moderate-high intensity)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
136 participants (estimated)

Study arms

  • Experimental
    Fisetin

    Dietary Supplement: Fisetin

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • Dietary supplementFisetin

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

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change from baseline in endothelial function at 3 months

    Brachial artery flow-mediated dilation

    Time frame: 3 months

Other outcomes

  1. Change from baseline in suppression of endothelial function by mitochondrial oxidative stress at 3 months

    Change in brachial artery flow-mediated dilation with acute, supratherapeutic MitoQ (160mg)

    Time frame: 3 months

  2. Change from baseline in the effects of circulating factors on endothelial cell nitric oxide (NO) and total and mitochondrial reactive oxygen species (mitoROS) production at 3 months

    Effects of changes circulating factors on endothelial cell nitric oxide (NO) and total and mitochondrial reactive oxygen species (mitoROS) production using human aortic endothelial cells in culture

    Time frame: 3 months

  3. Change from baseline in cerebrovascular function at 3 months

    Change in middle cerebral artery reactivity and/or internal carotid artery dilation to hypercapnia, and/or middle cerebral artery pulsatility index, and/or total cerebral blood flow at 3 months

    Time frame: 3 months

  4. Change from baseline in endothelial cell markers of cellular senescence at 3 months

    Endothelial cell expression of p16, p21 and markers of cell senescence

    Time frame: 3 months

  5. Change from baseline in markers of cellular senescence and the senescence-associated secretory phenotype (SASP) in circulation at 3 months

    Time frame: 3 months

  6. Change from baseline in large elastic artery stiffness at 3 months

    Change in aortic stiffness via carotid-femoral pulse wave velocity and/or carotid artery stiffness by carotid artery compliance

    Time frame: 3 months

  7. Change from baseline in cognitive function at 3 months

    Change in NIH Toolbox measures of cognitive function and/or assessed with the Trail Making Tests from baseline to 3 months

    Time frame: 3 months

07

Study locations

1 site
  • University of Colorado Boulder
    Boulder, Colorado 80309, United States
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Mar 2031, 52 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Nov 2026
Primary completionEst.
Mar 2031
CompletionEst.
Jun 2031
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
eligibility
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 15, 2026
    Eligibility Criteria revised
    + 1 other change: secondary outcomes
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07871162
Lead sponsor
University of Colorado, Boulder
Responsible party
Matthew Rossman (Assistant Professor, University of Colorado, Boulder) — Principal investigator
First posted
Oct 13, 2026
Start date
Nov 2026 (estimated)
Primary completion
Mar 2031 (estimated)
Completion
Jun 2031 (estimated)
Last update
Oct 15, 2026

Study contacts

Sarah Haydu
Contact
fisetintrial@colorado.edu
303-735-6410
Matthew J Rossman, PhD
principal investigator · University of Colorado, Boulder

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fisetin

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