What side effects are associated with this type of intervention?

Treatments for arterial stiffness that target mitochondrial oxidative stress, cellular senescence, and SASP factors, such as antioxidants and senolytics, can have side effects including gastrointestinal discomfort, fatigue, headaches, and nausea. These treatments are generally well-tolerated, but it is essential to consult with a healthcare provider to understand the specific risks and benefits.

What prior FDA approvals exist?

There is limited specific information on FDA-approved treatments for arterial stiffness that directly align with the mechanisms of fisetin, such as decreasing mitochondrial oxidative stress, cellular senescence, and SASP factors. However, treatments that improve vascular function and reduce oxidative stress, such as certain antioxidants and anti-inflammatory agents, may offer some benefits. For example, drugs that enhance endothelial function or reduce oxidative stress, like statins, have been used to manage related cardiovascular conditions. Further research and clinical trials are necessary to confirm the efficacy of such treatments specifically for arterial stiffness.

What other types of research exist?

Promising alternatives to Fisetin for treating arterial stiffness include: 1) Resveratrol, which has been shown to improve endothelial function and reduce oxidative stress. 2) Metformin, known for its anti-aging properties and ability to reduce cellular senescence. 3) Senolytics like Dasatinib and Quercetin, which target and eliminate senescent cells, thereby reducing SASP factors. These alternatives have shown potential in clinical studies for improving vascular health and reducing arterial stiffness.

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Flavonoid

Fisetin for Improved Vascular Function in Aging

Phase 1 & 2

Recruiting

Led By Matthew J Rossman, PhD

Research Sponsored by University of Colorado, Boulder

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 65 years or older

Women must be postmenopausal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Summary

This trial tests if fisetin, a natural substance from fruits and vegetables, can improve blood vessel health and reduce artery stiffness in older adults. It works by making old cells act younger, reducing cell stress, and lowering inflammation. The study will also check if fisetin is safe and well-tolerated. Fisetin is a natural flavonoid found in various fruits and vegetables, known for its antioxidant, anti-inflammatory, and anti-carcinogenic properties.

Who is the study for?

This trial is for people aged 65 or older, specifically postmenopausal women and men with a BMI under 40. Participants should not have had significant weight changes recently, must be free of serious chronic diseases like unstable heart conditions, and agree to not donate blood during the study.

What is being tested?

The trial is testing fisetin, a flavonoid compound thought to improve blood vessel function and reduce stiffness in arteries among older adults. It will compare fisetin's effects against a placebo while exploring how it might work by affecting oxidative stress and other aging-related factors.

What are the potential side effects?

While specific side effects are not listed here, the trial will monitor how well participants can tolerate fisetin and any adverse reactions they experience. This includes checking for any discomfort or health issues that arise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I have gone through menopause.

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My weight has been stable for the last 2 months and I can keep it stable during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in endothelial function at 1 month

Secondary study objectives

Change from baseline in aortic stiffness at 1 month

Other study objectives

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

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

Change from baseline in plasma markers of the senescence-associated secretory phenotype

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: FisetinActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for arterial stiffness, such as those being studied with fisetin, work by decreasing mitochondrial oxidative stress, cellular senescence, and SASP factors. These mechanisms are crucial because they target the root causes of arterial stiffness. Reducing oxidative stress minimizes cellular damage and improves endothelial function. Addressing cellular senescence helps maintain the regenerative capacity of vascular tissues, and lowering SASP factors reduces inflammation and tissue degradation. Together, these effects enhance vascular health and reduce arterial stiffness, which is vital for patients to prevent complications and improve overall cardiovascular function.