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

ConditionsAgingEndothelial DysfunctionCellular Senescence
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Colorado, Boulder

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 65 years or older

Women must be postmenopausal

Body mass index (BMI) <40 kg/m2

Willing to accept random assignment

Disqualifiers

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 established 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 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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fisetin

    Dietary supplement

    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.

  • Placebo

    Other intervention

    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.

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: FisetinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in endothelial function at 3 months

Brachial artery flow-mediated dilation

Time frame
3 months

Secondary outcomes

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 \[ICA\] dilation to hypercapnia, and/or MCA 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Boulder

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: