AgingPhase 1/2NCT06133634
Fisetin to Improve Vascular Function in Older Adults
A Phase 1/2 study testing Fisetin in people with Aging and Endothelial Dysfunction, run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Endothelial Dysfunction, Arterial Stiffness
- What is being tested?
- Fisetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to 31 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80305
About this study
Official title: Clinical Translation of Senolytic Therapy With Fisetin to Improve Vascular Function in Older Adults
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.
Read the detailed description
Cellular senescence increases with aging and contributes to physiological dysfunction. Studies in animal models show that the flavonoid compound fisetin is an effective treatment for reducing cellular senescence and improving vascular function with aging. No published studies have used fisetin to target cellular senescence in older adults to improve vascular function. In addition, the biological reasons (mechanisms) by which fistin may improve vascular function in older adults has not been assessed. This study will evaluate if intermittent treatment with fisetin in older adults improves vascular function, reduces biological markers of cellular senescence, oxidative stress and inflammatory factors produced by senescent cells (i.e., senescence-associated secretory phenotype factors). The study will also evaluate safety, tolerability and adherence with fisetin treatment.
- Conditions
- Aging, Endothelial Dysfunction, Arterial Stiffness
- Being tested
- Fisetin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FisetinDietary supplement
Fisetin dietary supplement
PlaceboOther
Placebo capsules identical in appearance to fisetin capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in endothelial function at 1 month
Brachial artery flow-mediated dilation
Measured: 1 month
Secondary outcomes (1)
Change from baseline in aortic stiffness at 1 month
Carotid-femoral pulse wave velocity
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start25 Sep 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel group design clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Matthew Rossman, University of Colorado, Boulder
- Investigators
- Matthew J Rossman, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133634
- Sponsor's protocol ID
- 23-0288
- Status last verified
- Sep 2026
- First submitted
- 10 Nov 2023
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Translation of Senolytic Therapy With Fisetin to Improve Vascular Function in Older Adults
- ClinicalTrials.gov ID
- NCT06133634
- Acronym / sponsor ID
- 23-0288
- Conditions
- Aging, Endothelial Dysfunction, Arterial Stiffness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cellular senescence increases with aging and contributes to physiological dysfunction. Studies in animal models show that the flavonoid compound fisetin is an effective treatment for reducing cellular senescence and improving vascular function with aging. No published studies have used fisetin to target cellular senescence in older adults to improve vascular function. In addition, the biological reasons (mechanisms) by which fistin may improve vascular function in older adults has not been assessed. This study will evaluate if intermittent treatment with fisetin in older adults improves vascular function, reduces biological markers of cellular senescence, oxidative stress and inflammatory factors produced by senescent cells (i.e., senescence-associated secretory phenotype factors). The study will also evaluate safety, tolerability and adherence with fisetin treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel group design clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Fisetin | Active comparator | Dietary Supplement: FisetinFisetin 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 | Placebo comparator | Other: PlaceboPlacebo capsules identical in appearance to fistin capsules will be administered in an intermittent manner with two, three-day dosing periods separated by two weeks. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FisetinFisetin dietary supplement | Dietary supplement | Fisetin |
| PlaceboPlacebo capsules identical in appearance to fisetin capsules | Other | Placebo |
Primary outcome
Change from baseline in endothelial function at 1 month
Time frame: 1 month
Brachial artery flow-mediated dilation
1 secondary outcome
Change from baseline in aortic stiffness at 1 month
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
Related trials for Aging
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Recruiting
Feasibility of A Smartphone Application Intervention in Community Settings: A Pretest-Posttest Pilot Study
Aging, Dementia
Recruiting
Fatty Acid Modulation of Brain Function in Older Adults
Aging
Recruiting
Effects of Breathing Exercises on Cognition in Older Adults
Older Adults (65 Years and Older), Cognition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J Rossman, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fisetin in people with Aging and Endothelial Dysfunction, run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in endothelial function at 1 month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.