Menu
Recruiting NCT07195318

Fisetin Supplementation for Healthy Aging

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fisetin, Placebo.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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).

Interventions

  • Dietary supplement Fisetin
    One capsule (100 mg) daily
  • Dietary supplement Placebo
    One capsule daily

Primary outcome measures

  • Soluble urokinase plasminogen activator receptor (suPAR) [Time frame: Baseline to Week 7]
Secondary outcome measures (1)
  • Side effects [Time frame: Baseline to Week 7]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Department of Clinical Research, Copenhagen University Hospital Amager & Hvidovre — Hvidovre

Identifiers

NCT: NCT07195318 · H-25043857

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗