Fisetin Supplementation for Healthy Aging

ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorOve Andersen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Fisetin

    Dietary supplement

    One capsule (100 mg) daily

  • Placebo

    Dietary supplement

    One capsule daily

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Soluble urokinase plasminogen activator receptor (suPAR)

The difference between groups in the change in plasma levels of suPAR

Time frame
Baseline to Week 7

Secondary outcomes

1

Side effects

Differences between groups in the type and frequency of side effects

Time frame
Baseline to Week 7

Other outcomes

1

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
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ove Andersen

Lead sponsor

Hvidovre University Hospital

Sponsor institution