About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Middle-aged or older adult (≥50 years),
Able to cooperate cognitively,
Able to read and understand Danish,
Disqualifiers
Inability or unwillingness to take oral supplements,
Chronic or recent (within 30 days) use of other anti-aging supplements,
Chronic or recent (within 30 days) treatment with medications having anti-aging effects (e.g., metformin, rapamycin, semaglutide),
Chronic or recent (within 30 days) treatment with anti-inflammatory medications,
Trial design
Parallel
Treatments tested in this trial
Fisetin
Dietary supplementOne capsule (100 mg) daily
Placebo
Dietary supplementOne capsule daily
Treatment groups
Trial outcomes
Primary outcomes
Soluble urokinase plasminogen activator receptor (suPAR)
The difference between groups in the change in plasma levels of suPAR
Secondary outcomes
Side effects
Differences between groups in the type and frequency of side effects
Other outcomes
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).
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) .
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).
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.
Sponsors and contacts
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Ove Andersen
Lead sponsor
Hvidovre University Hospital
Sponsor institution