💬In plain words
What the trial is, and whether it could suit you
This Phase II, randomized, double-blind, placebo-controlled pilot study will evaluate the effects of fisetin, a senolytic flavonoid compound, on lung function and biomarkers of cellular senescence in older adults aged 60 years and older. Participants will include individuals with a history of at least 10 pack-years of smoking as well as age-matched never-smokers. Forty participants will be randomized to receive either fisetin or placebo using a short-course "hit-and-run" dosing strategy (approximately 20 mg/kg/day orally for 2 consecutive days on Days 1-2 and Days 8-9).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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