Impact of Urolithin A (Mitopure) on Mitochondrial Quality in Muscle of Frail Older Adults
Not Applicable
Recruiting
- Conditions
- FrailtyMuscle AtrophySarcopeniaAging
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Mitopure (Urolithin A)
- Registration Number
- NCT06556706
- Lead Sponsor
- Amazentis SA
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 26
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Mitopure (Urolithin A) Mitopure (Urolithin A) -
- Primary Outcome Measures
Name Time Method Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy 8-weeks Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy 8-weeks
- Secondary Outcome Measures
Name Time Method Changes in distance walked during the six-minute walk test 8-weeks Changes in knee extension strength measured by a hand dynamometer 8-weeks change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium 8-weeks Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass 8-weeks Changes in grip strength measured by a hand dynamometer 8-weeks mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR 8-weeks Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue 8-weeks Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining) 8-weeks change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabilized myofibers 8-weeks Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floor 8-weeks Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling 8-weeks Changes in the timed up and go test (time needed to stand from an armchair, walk a distance of 3 meters, turn around and sit back down in the chair) 8-weeks Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task 8-weeks Changes in the 30-second stand test: Participant will stand as many times as s/he can from a seated position for 30-seconds. 8-weeks Changes in Unipedal stance test (UPST): First a ball will be kicked to determine dominant leg, then participant will be asked to stand on one leg (barefoot) with eyes open and again with eyes closed 8-weeks Recording of adverse events 8-weeks
Trial Locations
- Locations (1)
McGill University Health Center
🇨🇦Montréal, Canada