Low-Dose Fisetin Supplementation and Its Association With Chronic Inflammation in Middle-Aged and Older Adults: Study Protocol for a Triple-Blind, Randomised, Placebo-Controlled Trial

Juliette Tavenier, Magnus Berglind, Line Fleischer Hach, Louise Westberg Strejby Christensen, Jan Olof Nehlin, Morten Baltzer Houlind, Ove Andersen, Line Jee Hartmann Rasmussen

1. 01

   Design: triple-blind, randomised, placebo-controlled; adults aged 50 and over

2. 02

   Intervention: 100 mg oral fisetin once daily for 7 weeks vs placebo - continuous low dose, not intermittent high-dose senolytic pulsing

3. 03

   Primary outcome: between-group change in plasma suPAR from baseline to week 7

4. 04

   Secondary outcome: occurrence and severity of adverse events

5. 05

   Exploratory: other inflammation, aging and cellular-senescence biomarkers, frailty, physical and cognitive function

6. 06

   Endpoint choice implicitly concedes that senescent-cell quantification in humans remains unreliable

Study Design

clinical_trial_protocol

Sample Size

Not reported

Study Duration

7 weeks

Methodology

Triple-blind randomised placebo-controlled trial protocol; generally healthy community-dwelling adults aged 50+; 7-week intervention; plasma suPAR as primary biomarker endpoint.

Limitations

This is a study PROTOCOL: no efficacy or safety results have been reported. The primary endpoint is a biomarker (suPAR), not a clinical outcome, and not a measure of senescent-cell burden. Duration is short (7 weeks), the population is generally healthy, and the dose is low and continuous, so results will not generalise to the high-dose intermittent regimens used in most clinics. Fisetin still has no positive controlled human outcome trial.