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

NCT06556706 | Completed

• 1 other identifier: 2024-10182
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Frailty; Sarcopenia; Aging; Muscle Atrophy

Keywords

mitophagy; Urolithin A

Outcome Measures

Primary Outcomes (2)

• Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy

  8-weeks

• Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy

  8-weeks

Secondary Outcomes (16)

• change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabilized myofibers

  8-weeks

• change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium

  8-weeks

• mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR

  8-weeks

• Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass

  8-weeks

• Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue

  8-weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Mitopure (Urolithin A)

ACTIVE COMPARATOR

Dietary Supplement: Mitopure (Urolithin A)

Interventions

Mitopure (Urolithin A) DIETARY_SUPPLEMENT

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).

Mitopure (Urolithin A)

Placebo DIETARY_SUPPLEMENT

Placebo containing excipients other than Urolithin A (Mitopure)

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Frail (as defined by the Fried frailty criteria)nonsmoking participants in the age group of 65 to 85 years old, both male and female.
• A body mass index between 18 to 35 kg/m2.
• Not on any medications/living with medical conditions that would compromise the study outcome or the safety of the research participant.
• Able to participate and willing to give written informed consent and to comply with the study restrictions.
• Willing to be assigned randomly either to the UA or the control group.

You may not qualify if:

• Participants must not have:
• Participated in a clinical trial within 90 days of screening or more than 4 times in the previous year.
• A history (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol).
• A history or presence of allergy to 5-aminolevulinic acid or porphyrins.
• A history or presence of allergy to lidocaine.
• Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
• Unwillingness or inability to refrain from consuming alcohol within 48 hours before each visit until the end of said visit.
• Unwillingness or inability to refrain from consuming 8 or more units of xanthine containing beverages and foods per day during the entire study.
• Unwillingness to not consume other mitochondrial supplements during the course of the study (such as CoQ10, reseveratrol, NR, NMN etc.) and pomegranate juice
• unwillingness to not change diet or physical activity levels during the course of the study
• Unwillingness or inability to undergo a muscle biopsy.
• Underlying chronic disease, which in the opinion of the investigator, would interfere with study participation or the validity of the measurements.
• Unintentional weight loss ≤5% of regular body weight during the last 6 months.
• Medication requirements that may interfere with the interpretation of the results.
• Loss or donation of blood over 500mL three months prior (male subjects) or four months prior (female subjects) to participating in the study.

Sponsors & Collaborators

• Amazentis SA: lead
• Université du Québec a Montréal: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

McGill University Health Center

Montreal, Canada

Location

MeSH Terms

Conditions

Frailty; Sarcopenia; Muscular Atrophy

Interventions

3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• José Morais

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Gilles Gouspillou, PhD

  UQAM (University of Quebec at Montreal)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 16, 2024
• Study Start: August 15, 2024
• Primary Completion: April 25, 2025
• Study Completion: April 25, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)