Ongoing Lung Decline With Age Intensified Response
ConditionAge-Related Lung Function Decline
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorCedars-Sinai Medical Center
About this trial
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).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Fisetin
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov