Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults

NCT06556706 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-05-28

No results posted yet for this study

Summary

The study is a single-center, randomized, placebo-control double-blind study in frail older adults over 65yrs. to investigate the impact of Mitopure (Urolithin A) supplementation on muscle mitochondrial quality in frail older adults after 8-weeks of supplementation

Conditions

Interventions

DIETARY_SUPPLEMENT

Mitopure (Urolithin A)

UA is produced by the gut microbiome following the digestion of dietary precursors (polyphenols such as ellagitannins and punicalagins) present in fruits and nuts such as pomegranate, nuts and berries. In mouse models of aging and muscle dystrophy, UA was shown to induce mitophagy and mitochondrial function in the skeletal muscle. This was associated with improved muscle strength and endurance (Nat. Med, 2016; Sci Tran Med, 2021). In humans, UA was shown to be safe and bioavailable in multiple clinical studies (Nat. Met, 2019; Cell Rep Med, 2022; JAMA Network Open, 2022).

DIETARY_SUPPLEMENT

Placebo

Placebo containing excipients other than Urolithin A (Mitopure)

Sponsors & Collaborators

  • Université du Québec a Montréal

    collaborator OTHER
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER
  • Amazentis SA

    lead INDUSTRY

Principal Investigators

  • José Morais · McGill University Health Centre/Research Institute of the McGill University Health Centre

  • Gilles Gouspillou, PhD · UQAM (University of Quebec at Montreal)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2025-04-25
Completion
2025-04-25

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06556706 on ClinicalTrials.gov