Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults (NCT06556706) | Clinical Trial Compass
CompletedNot Applicable
Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults
Canada26 participantsStarted 2024-08-15
Plain-language 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
Who can participate
Age range
65 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, N…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy
Timeframe: 8-weeks
2
Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy