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| Name | Class |
|---|---|
| Université du Québec a Montréal | OTHER |
| McGill University Health Centre/Research Institute of the McGill University Health Centre | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Mitopure (Urolithin A) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure (Urolithin A) | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mitochondrial area between placebo and active treated groups assessed via Electron Microscopy | 8-weeks | |
| Change in mitochondrial cristae density between placebo and active treated groups assessed via Electron Microscopy | 8-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change between groups on the following: maximal mitochondrial O2 consumption assessed via via respirometry on permeabilized myofibers | 8-weeks | |
| change between groups in mitochondrial calcium retention capacity measured by mitochondrial permeability transition pore (mPTP) sensitivity to calcium |
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Inclusion Criteria:
Exclusion Criteria:
Participants must not have:
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| Name | Affiliation | Role |
|---|---|---|
| José Morais | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Gilles Gouspillou, PhD | UQAM (University of Quebec at Montreal) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Center | Montreal | Canada |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| C026423 | 3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one |
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|
| Placebo | Dietary Supplement | Placebo containing excipients other than Urolithin A (Mitopure) |
|
| 8-weeks |
| mitochondrial DNA (mtDNA) over nuclear DNA ratio (mtDNA/nDNA) via qPCR | 8-weeks |
| Changes in body composition via Dual X-ray Absorptiometry (DXA) scan of total and appendicular lean mass | 8-weeks |
| Changes in composition via Peripheral quantitative computed tomography (pQCT) of muscle tissue | 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 grip strength measured by a hand dynamometer | 8-weeks |
| Changes in Berg balance test: Participant will be asked to maintain a given position or perform a task | 8-weeks |
| Changes in distance walked during the six-minute walk test | 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 Four-square step test: To assess balance, participant will step over small sticks placed in an X on the floor | 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 |
| Quantification of muscle fiber type (type I/II) via Myosin Heavy Chain immunolabeling | 8-weeks |
| Analysis of markers of neuromuscular junction integrity (NCAM biomarker staining) | 8-weeks |
| Changes in knee extension strength measured by a hand dynamometer | 8-weeks |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |