跳至主要内容
临床试验/NCT07195318
NCT07195318招募中不适用

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

Ove Andersen2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月24日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
2
主要终点
Soluble urokinase plasminogen activator receptor (suPAR)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Placebo group

Placebo Comparator

Placebo daily for 7 weeks

干预措施: Placebo (Dietary Supplement)

Treatment group

Experimental

Fisetin daily for 7 weeks

干预措施: Fisetin (Dietary Supplement)

结局指标

主要结局

Soluble urokinase plasminogen activator receptor (suPAR)

时间窗: Baseline to Week 7

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

次要结局

  • Side effects(Baseline to Week 7)

研究者

发起方
Ove Andersen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ove Andersen

Head of Research, Clinical Professor, Principal Investigator

Hvidovre University Hospital

研究点 (2)

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