Fisetin to Improve Vascular Function in Older Adults

NCT06133634 | Active Not Recruiting Phase 1

• 1 other identifier: 23-0288
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in endothelial function at 1 month

  Brachial artery flow-mediated dilation

  1 month

Secondary Outcomes (1)

• Change from baseline in aortic stiffness at 1 month

  1 month

Other Outcomes (4)

• Change from baseline in suppression of endothelial function by mitochondrial oxidative stress at 1 month

  1 month

• Change from baseline in endothelial cell markers of cellular senescence at 1 month

  1 month

• Change from baseline in blood cell markers of cellular senescence at 1 month

  1 month

Study Arms (2)

Fisetin

ACTIVE COMPARATOR

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.

Dietary Supplement: Fisetin

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Fisetin DIETARY_SUPPLEMENT

Fisetin dietary supplement

Fisetin

Placebo OTHER

Placebo capsules identical in appearance to fisetin capsules

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to refrain from alcohol for 24 hours prior to outcome assessment
• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• American Heart Association: collaborator

Study Sites (1)

University of Colorado Boulder

Boulder, Colorado, 80305, United States

Location

MeSH Terms

Interventions

fisetin

Study Officials

• Matthew J Rossman, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: Randomized, double-blind, placebo-controlled, parallel group design clinical trial.

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: September 25, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)