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

Not Applicable
Recruiting
Conditions
Frailty
Muscle Atrophy
Sarcopenia
Aging
Interventions
Dietary Supplement: Placebo
Dietary 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
GroupInterventionDescription
PlaceboPlacebo-
Mitopure (Urolithin A)Mitopure (Urolithin A)-
Primary Outcome Measures
NameTimeMethod
Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy8-weeks
Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy8-weeks
Secondary Outcome Measures
NameTimeMethod
Changes in distance walked during the six-minute walk test8-weeks
Changes in knee extension strength measured by a hand dynamometer8-weeks
change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium8-weeks
Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass8-weeks
Changes in grip strength measured by a hand dynamometer8-weeks
mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR8-weeks
Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue8-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 myofibers8-weeks
Changes in Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floor8-weeks
Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling8-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 task8-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 closed8-weeks
Recording of adverse events8-weeks

Trial Locations

Locations (1)

McGill University Health Center

🇨🇦

Montréal, Canada

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