Fisetin Supplementation for Healthy Aging

NCT07195318 | Recruiting

• 1 other identifier: H-25043857
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Chronic inflammation; Cellular senescence; Senotherapeutics

Outcome Measures

Primary Outcomes (1)

• Soluble urokinase plasminogen activator receptor (suPAR)

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

  Baseline to Week 7

Secondary Outcomes (1)

• Side effects

  Baseline to Week 7

Other Outcomes (14)

• SASP factors and inflammation markers

  Baseline to Week 7

• Cellular senescence

  Baseline to Week 7

• Aging biomarkers

  Baseline to Week 7

Study Arms (2)

Treatment group

EXPERIMENTAL

Fisetin daily for 7 weeks

Dietary Supplement: Fisetin

Placebo group

PLACEBO COMPARATOR

Placebo daily for 7 weeks

Dietary Supplement: Placebo

Interventions

Fisetin DIETARY_SUPPLEMENT

One capsule (100 mg) daily

Treatment group

Placebo DIETARY_SUPPLEMENT

One capsule daily

Placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ove Andersen: lead

Study Sites (1)

Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Interventions

fisetin

Study Officials

• Juliette Tavenier

  Copenhagen University Hospital, Amager and Hvidovre

  STUDY CHAIR

• Line Jee Hartmann Rasmussen

  Copenhagen University Hospital, Amager and Hvidovre

  STUDY CHAIR

• Morten B Houlind

  Copenhagen University Hospital, Amager and Hvidovre

  STUDY CHAIR

• Magnus Berglind

  Copenhagen University Hospital, Amager and Hvidovre

  STUDY CHAIR

• Line Fleischer Hach

  Copenhagen University Hospital, Amager and Hvidovre

  STUDY CHAIR

Central Study Contacts

Juliette Tavenier

CONTACT

+45 38620958; juliette.tavenier@regionh.dk

Line Jee Hartmann Rasmussen

CONTACT

+45 38620640; line.jee.hartmann.rasmussen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research, Clinical Professor, Principal Investigator

Model Details: The study is a 2-arm triple-blind randomized placebo-controlled trial, in which middle-aged and older adults will receive either: * 100 mg fisetin daily for 7 weeks (intervention group), or * placebo daily for 7 weeks (control group).

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 26, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): September 20, 2035
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

DK (1)