Status:
COMPLETED
Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults
Lead Sponsor:
Amazentis SA
Collaborating Sponsors:
Université du Québec a Montréal
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Frailty
Sarcopenia
Eligibility:
All Genders
65-85 years
Phase:
NA
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 mitochondri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06556706
Start Date
August 15 2024
End Date
April 25 2025
Last Update
May 28 2025
Active Locations (1)
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1
McGill University Health Center
Montreal, Canada