Tier 4 — mechanistic

REVITALiSE: Randomised Evaluation Platform — Interventions to Treat Older People With Sarcopenia

Miles Witham, Philippa Watts
ISRCTN trial registry record 2025

Bibliography

Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Funded by the NIHR Newcastle Biomedical Research Centre; sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust.
Competing interests
No manuscript-level competing-interest statement is available for this registry protocol.

Study snapshot

DesignSingle-centre open-label platform trial with independently randomized parallel subtrials; the initial subtrial compares fisetin with usual care.
ModelAdults aged 65 years and older with low grip strength or impaired sit-to-stand performance consistent with sarcopenia.
SampleApproximately 36 participants planned for the fisetin subtrial; the platform protocol states roughly 30-40 per subtrial.
InterventionFisetin 400 mg capsules once daily for three consecutive days every two weeks for 12 weeks. Weight-based daily dose: 800 mg at ≤50 kg, 1,200 mg at 50-69.9 kg, 1,600 mg at 70-89.9 kg, and 2,000 mg at ≥90 kg. Comparator: usual care.
Duration12 weeks.
EndpointsPrimary: 4-metre walk speed; Grip strength; Physical activity and digital mobility outcomes; Short Physical Performance Battery; Adherence; Adverse events; Muscle biopsy and mechanistic outcomes

What the study showed, in plain terms

REVITALiSE is a UK platform trial designed to rapidly test candidate treatments for sarcopenia. The initial subtrial directly compares intermittent weight-based fisetin with usual care over 12 weeks.

The study is recruiting and no results are available. It is important because it uses functional mobility endpoints and muscle biopsies in older adults, but the dosing schedule remains experimental rather than an established treatment for sarcopenia.

Key findings

  • The fisetin subtrial uses three consecutive treatment days every two weeks for 12 weeks.
  • Daily dose ranges from 800 to 2,000 mg according to body weight.
  • Primary outcome is 4-metre walk speed, with grip strength, physical activity and mechanistic muscle measures as secondary outcomes.

What this study can and cannot tell us

  • No results available.
  • Open-label design can influence subjective and behavioral outcomes.
  • Small proof-of-concept subtrial rather than definitive efficacy trial.
  • Weight-based research schedule should not be treated as a personal dosing recommendation.

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