RECRUITING

Fisetin to Improve Vascular Function in Older Adults

Conditions

Aging Endothelial Dysfunction Arterial Stiffness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Translation of Senolytic Therapy With Fisetin to Improve Vascular Function in Older Adults

Quick Facts

Study Start:2023-09-25

Study Completion:2027-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06133634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Sarah Haydu, MA

CONTACT

303-735-6410

fisetinstudy@colorado.edu

Principal Investigator

Matthew J Rossman, PhD

PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Study Locations (Sites)

University of Colorado Boulder

Boulder, Colorado, 80305

United States

Collaborators and Investigators

Sponsor: University of Colorado, Boulder

Matthew J Rossman, PhD, PRINCIPAL_INVESTIGATOR, University of Colorado, Boulder

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-25

Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-09-25

Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

Aging
Endothelial Dysfunction
Arterial Stiffness