An interventional study of Fisetin and Placebo in Healthy, sponsored by Ove Andersen. Recruiting at 1 site in Denmark. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Ove Andersen · Not applicable, Interventional, and Treatment
There is growing interest among the general population in preventive health interventions that can help mitigate age-related decline, reduce the risk of chronic diseases, and promote healthy aging. The use of nutritional supplements has been increasing and is especially high in older adults and healthier individuals. In response to this demand, a growing number of nutritional supplements are being advertised for their "anti-aging" properties, claiming to target molecular and cellular "hallmarks of aging", such as chronic inflammation, oxidative stress, and cellular senescence. However, the overwhelming majority of these claims stem from preclinical studies in animal models (e.g., C. elegans, mice), and there is extremely limited evidence for beneficial effects, effective doses, or safety profiles of these supplements in humans. Moreover, the lack of strict regulations in the nutritional supplement industry leads to wide differences in the quality and in the actual content of active substances between supplements, which could impact both their efficacy and safety.
The investigators will conduct a clinical trial in healthy volunteers, who will receive supplementation with fisetin (100 mg) or placebo daily for 7 weeks. Participants will be examined at regular intervals during the study period. The investigators will then investigate whether fisetin supplementation is safe and evaluate its effect on measures of chronic inflammation, cellular senescence, aging, and general health.
The goal of this study is to assess the anti-inflammatory effects, overall health benefits, and the safety of a daily low dose (100 mg) of fisetin in relatively healthy middle-aged and older adults.
The study is a 2-arm triple-blind randomized placebo-controlled trial, in which middle-aged and older adults (n=120) will receive either:
Exclusion Criteria:
Fisetin daily for 7 weeks
Dietary Supplement: Fisetin
Placebo daily for 7 weeks
Dietary Supplement: Placebo
One capsule (100 mg) daily
One capsule daily
Soluble urokinase plasminogen activator receptor (suPAR)
The difference between groups in the change in plasma levels of suPAR
Time frame: Baseline to Week 7
Side effects
Differences between groups in the type and frequency of side effects
Time frame: Baseline to Week 7
SASP factors and inflammation markers
Differences between groups in the change in plasma concentrations (pg/mL) of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors).
Time frame: Baseline to Week 7
Cellular senescence
Differences between groups in the change in the percentage of immune cells positive for expression of senescence markers (e.g., p16INK4a, p21CIP1/WAF1, SA-B-gal) .
Time frame: Baseline to Week 7
Aging biomarkers
Differences between groups in the change in plasma concentrations (pg/mL) of aging markers (e.g., α-klotho, growth differentiation factor 15, fibroblast growth factor 21).
Time frame: Baseline to Week 7
Frailty
Differences between groups in the change in frailty status calculated as Frailty Index OutRef (FI-OutRef) based on the values of 17 routine biochemistry biomarkers. The score ranges from 0-17, with higher scores indicating greater frailty.
Time frame: Baseline to Week 7
Clinical biomarkers
Differences between groups in the change in levels of routine biochemistry markers (e.g., alanine aminotransferase, albumin, alkaline phosphatase, bilirubin, blood urea nitrogen, coagulation factors II, VII and X, CRP, creatinine, hemoglobin, lactate dehydrogenase, mean corpuscular hemoglobin concentration, mean corpuscular volume, neutrophils, potassium, sodium, thrombocytes, white blood cell count, cystatin C, cholesterol (total, low-density lipoproteins, high-density lipoproteins), triglycerides, and hemoglobin A1c).
Time frame: Baseline to Week 7
Physical function
Differences between groups in the change in gait speed (m/s).
Time frame: Baseline to Week 7
Physical function
Differences between groups in the change in hand grip strength (kg).
Time frame: Baseline to Week 7
Physical function
Differences between groups in the change in chair stand test score (number of repetitions).
Time frame: Baseline to Week 7
Physical function
Differences between groups in the change in balance score (0-4 points, with higher scores indicating poorer balance).
Time frame: Baseline to Week 7
Cognitive function
Differences between groups in the change in cognitive function assessed using the Montreal Cognitive Assessment (MoCA) score (0-30, with higher values indicating better cognitive function).
Time frame: Baseline to Week 7
Cognitive function
Differences between groups in the change in cognitive function assessed using the Digit Symbol Substitution Test (DSST), with higher scores indicating better cognitive function.
Time frame: Baseline to Week 7
Health-related quality of life
Differences between groups in the change in quality of life assessed using the EuroQol-5D-5L. The score ranges from 1 to -0.757, which higher values indicating better quality of life.
Time frame: Baseline to Week 7
Self-rated health
Differences between groups in the change in self-rated health, classified as excellent, very good, good, fair, or poor.
Time frame: Baseline to Week 7
CYP3A4 activity
Differences between groups in the change in CYP3A4 activity assessed using the concentration of the endogenous marker 4β-hydroxycholesterol measured in plasma samples using LC-MS/MS.
Time frame: Baseline to Week 7
Plan to share: Undecided
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Ove Andersen