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NCT Number: NCT07195318

Fisetin Supplementation for Healthy Aging

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.

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Key information

Conditions

Healthy

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre

Hvidovre, 2650, Denmark

Location status: Recruiting

Location contact

Juliette Tavenier

CONTACT

[email protected]

+4538620958

About this study

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:

  • One capsule (100 mg) fisetin daily for 7 weeks (intervention group), or
  • One capsule placebo daily for 7 weeks (control group).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Middle-aged or older adult (≥50 years),
  • Able to cooperate cognitively,
  • Able to read and understand Danish,

Exclusion criteria

  • 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,
  • Chronic or recent (within 30 days) treatment with the medications that can interact negatively with fisetin,
  • Recent (within 14 days) vaccination,
  • Treatment with another investigational drug or other intervention within 1 year,
  • Active cancer or current cancer treatment,
  • Unstable or uncontrolled major disorders, e.g., cardiovascular, renal, endocrine, immunological, hepatic disorder, or cancer, requiring regular monitoring at the hospital
  • Planned medical and surgical procedures during the study period,
  • Known hypersensitivity or allergy to fisetin or excipients in the placebo capsules,
  • Presence of any condition that the investigator believes would put the participant at risk or would preclude the participant from successfully completing all aspects of the study

Treatment and study plan

Fisetin

Dietary Supplement

One capsule (100 mg) daily

Placebo

Dietary Supplement

One capsule daily

Primary outcomes

  1. Soluble urokinase plasminogen activator receptor (suPAR)

    Time frame: Baseline to Week 7

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

Secondary outcomes

  1. Side effects

    Time frame: Baseline to Week 7

    Differences between groups in the type and frequency of side effects

Other outcomes

  1. SASP factors and inflammation markers

    Time frame: Baseline to Week 7

    Differences between groups in the change in plasma concentrations (pg/mL) of SASP factors and inflammation markers (e.g., cytokines, chemokines, proteases, growth factors).

  2. Cellular senescence

    Time frame: Baseline to Week 7

    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) .

  3. Aging biomarkers

    Time frame: Baseline to Week 7

    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).

  4. Frailty

    Time frame: Baseline to Week 7

    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.

  5. Clinical biomarkers

    Time frame: Baseline to Week 7

    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).

  6. Physical function

    Time frame: Baseline to Week 7

    Differences between groups in the change in gait speed (m/s).

  7. Physical function

    Time frame: Baseline to Week 7

    Differences between groups in the change in hand grip strength (kg).

  8. Physical function

    Time frame: Baseline to Week 7

    Differences between groups in the change in chair stand test score (number of repetitions).

  9. Physical function

    Time frame: Baseline to Week 7

    Differences between groups in the change in balance score (0-4 points, with higher scores indicating poorer balance).

  10. Cognitive function

    Time frame: Baseline to Week 7

    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).

  11. Cognitive function

    Time frame: Baseline to Week 7

    Differences between groups in the change in cognitive function assessed using the Digit Symbol Substitution Test (DSST), with higher scores indicating better cognitive function.

  12. Health-related quality of life

    Time frame: Baseline to Week 7

    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.

  13. Self-rated health

    Time frame: Baseline to Week 7

    Differences between groups in the change in self-rated health, classified as excellent, very good, good, fair, or poor.

  14. CYP3A4 activity

    Time frame: Baseline to Week 7

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juliette Tavenier

CONTACT

[email protected]

+45 38620958

Line Jee Hartmann Rasmussen

CONTACT

[email protected]

+45 38620640

Sponsors and collaborators

Lead sponsor

Ove Andersen

Other

Registry information

Official study title

Low-dose Fisetin Supplementation for Healthy Aging - a Triple-blind, Randomized, Placebo-controlled Trial

Acronym: Fisetin LOW

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 26, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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