Fisetin for Lung Health in Older Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II randomized, double-blind, placebo-controlled pilot study will give participants a brief, two-day course of fisetin (approx. 20 mg/kg/day for two consecutive days, on days 1–2 and 8–9) or placebo to see if it favorably affects lung function and cellular aging markers in older adults with varying smoking histories. The trial will assess pulmonary performance, adverse events, and biomarker changes related to cellular senescence over a two-week period. By including both former smokers and never-smokers, the study aims to understand whether intermittent senolytic therapy can influence aging-related pulmonary decline. Results will inform the design of larger trials evaluating senolytics for lung health in aging populations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 60 years and older who are physically capable of participating in study procedures;
* Willing to be randomized to fisetin or placebo; weight stable within the previous 2 months (\<5-pound change);
* No blood donation within 2 months before screening; absence of unstable chronic disease;
* Willing to maintain baseline activity level throughout the study;
* Body mass index \<30 kg/m²;
* Either a history of at least 10 pack-years of cigarette smoking or never-smoking status.

Exclusion Criteria:

* Electrocardiogram (ECG) abnormalities, including prolonged QTc.
* Use of fisetin, other flavonoid supplements, or known senolytic compounds within 6 months prior to screening.
* Resting systolic blood pressure \>160 mmHg or diastolic blood pressure \>110 mmHg.
* Known allergy or hypersensitivity to fisetin or any component of the study product.
* Active malignancy, except non-melanoma skin cancer.
* Clinically significant hepatic, renal, cardiovascular, endocrine, immunologic, metabolic, or other uncontrolled medical conditions that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
* Clinically significant laboratory abnormalities, including severe anemia, leukopenia, thrombocytopenia, uncontrolled diabetes, advanced kidney disease, significant liver dysfunction, or evidence of systemic inflammation.
* Human immunodeficiency virus (HIV) infection, active hepatitis B or hepatitis C infection, or invasive fungal infection.
* History of diverticulitis or diverticulosis with gastrointestinal bleeding.
* Current use of systemic corticosteroids.
* Current use of warfarin.
* Current use of medications with significant interaction potential with fisetin, including selected CYP450 or transporter substrates, inhibitors, or inducers, unless such medications can be safely withheld according to protocol requirements.
* Recent medication, supplement, or lifestyle changes that may affect study outcomes, in the opinion of the investigator.
* Inability to perform required study procedures, including pulmonary function testing, exercise testing, or other protocol assessments.
* Unwillingness or inability to provide informed consent.
* Pregnancy or breastfeeding.
* Any other condition that, in the opinion of the investigator, would make participation unsafe or compromise study integrity.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Samuel Cohen, MD
• Email: samuel.cohen@csmc.edu
• Phone: 424-315-0685

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.