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

NCT ID: NCT06556706

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-04-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo containing excipients other than Urolithin A (Mitopure)

Mitopure (Urolithin A)

Group Type: ACTIVE_COMPARATOR

Mitopure (Urolithin A)

Intervention Type: 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).

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo containing excipients other than Urolithin A (Mitopure)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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.
• Smoked (tobacco and/or marijuana mixed with tobacco (THC)) within 6 months prior to the start of the study;
• Abused drugs, medicine or alcohol within up to 30 days prior to the start of the study (Alcohol: more than 10 drinks a week, with more than 2 drinks a day most days; Drugs: THC, cocaine, opiates, amphetamines/methamphetamines, benzodiazepines, barbiturates, Buprenorphine, Creatin, Methadone metabolite, oxycodone, phencyclidine);
• A positive COVID-19 test taken 1 week to 24h before study start date.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université du Québec a Montréal

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Amazentis SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Morais

Role: PRINCIPAL_INVESTIGATOR

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

Gilles Gouspillou, PhD

Role: PRINCIPAL_INVESTIGATOR

UQAM (University of Quebec at Montreal)

Locations

McGill University Health Center

Montreal, , Canada

Countries

Canada

Other Identifiers

2024-10182

Identifier Type: -

Identifier Source: org_study_id