Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1178231 | Other Identifier | WIRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Washington | OTHER |
| Synteract, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, single-center, placebo-controlled Phase 2 trial enrolling 66 healthy elderly subjects (33 placebo and 33 AMAZ-02 administration) who are ≥65 and ≤ 90 years of age with evidence of low mitochondrial function. AMAZ-02 or placebo will be orally administered for 4 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitopure | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure | Dietary Supplement | Mitopure (Urolithin A) containing softgels |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute walking distance (6MWD) at the end of study intervention compared to baseline | 4 months | |
| Percent change from baseline in ATP max (maximal ATP synthesis rate) in hand skeletal muscle (via Magnetic Resonance Spectroscopy) | 2, 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in contraction number during a hand muscle fatigue test | 2, 4 months | |
| Percent change from baseline in ATP max (maximum ATP synthesis rate) in leg skeletal muscle (via MRS) | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Marcinek, PhD | University of Washington | Principal Investigator |
| Jose Garcia, MD | VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35050355 | Result | Liu S, D'Amico D, Shankland E, Bhayana S, Garcia JM, Aebischer P, Rinsch C, Singh A, Marcinek DJ. Effect of Urolithin A Supplementation on Muscle Endurance and Mitochondrial Health in Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2144279. doi: 10.1001/jamanetworkopen.2021.44279. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
Placebo containing softgels |
|
| Percent change from baseline in contraction number during a leg muscle fatigue test | 4 months |
| Change in Short Physical Performance Battery (SPPB) scores at the end of study intervention compared to baseline | 4 months |
| Change in exercise tolerance compared to baseline (via cycle ergometry) | 4 months |
| Change in hand grip strength at the end of study intervention compared to baseline | 4 months |
| Change in leg muscle strength (1-RM and 10-RM) at the end of study intervention compared to baseline | 4 months |
| Change in muscle size (cross-sectional area of the muscles) at the end of study intervention compared to baseline | 4 months |
| Change in mitochondrial function on muscle biopsy samples at the end of study intervention compared to baseline (via respirometry) | 4 months |
| Effect of AMAZ-02 on mitochondrial gene and protein expression in muscle tissue | 4 months |
| Effect of AMAZ-02 on plasma acylcarnitines | 4 months |
| Effect of AMAZ-02 on quality of life questionnaire (SF36) | 4 months |
| Change from baseline in plasma lipid profile | 4 months |
| Change from baseline in plasma for circulating biomarkers (myostatin, follistatin) | 4 months |