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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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This is a Phase 2 randomized, double-blind, placebo-controlled study enrolling 90 healthy, overweight, middle aged subjects (30 placebo, 30 low dose and 30 high dose AMAZ-02 intervention), 40-65 years of age, who are otherwise healthy. AMAZ-02, a food derived ingredient, will be given as a daily oral dose for 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mitopure 500mg | Active Comparator |
| |
| Mitopure 1000mg | Active Comparator |
| |
| Placebo | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure 500mg | Dietary Supplement | Mitopure containing softgels |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 120 between AMAZ-02 groups and placebo | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise tolerance as assessed by power output on the cycle ergometer from baseline to day 60 between AMAZ-02 groups and placebo | 2 months | |
| Change in exercise tolerance as assessed by time to fatigue on the cycle ergometer from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo |
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Inclusion Criteria:
Healthy males and females 40 to 65 years of age, inclusive
Subjects who have not participated within the last 1 year in clinical trials focused on improving muscle function and physical performance
Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or,
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Body mass index (BMI) between 25.0 and 34.9 kg/m2, inclusive
Agree to avoid exercising 24 hours prior to study visits and maintain low physical activity status for the duration of the trial
Agree to refrain from consumption of pomegranate juice and walnuts from 2 weeks prior to baseline and through the study period
Agree to limit consumption of raspberries, strawberries and cloudberries from 2 weeks prior to baseline and through the study period
Agree to refrain from using NSAIDs for 7-days prior to and following muscle sample collection
Good general health to perform exercise testing safely, as determined by the Qualified Investigator based on medical history, physical examination, ECG and laboratory results
Low VO2max defined as <35 ml/kg/min for males and <31 ml/kg/min for females as assessed by a submaximal cycle ergometer test
Comprehension of the nature and purpose of the study including possible risks and side effects, and ability to communicate in person and by telephone in a manner that allows all protocol procedures to be carried out safely and reliably in the opinion of the investigative site staff
Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mal Evans, PhD | KGK Science Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Synergize Inc. | London | Ontario | N6A 5R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35584623 | Background | Singh A, D'Amico D, Andreux PA, Fouassier AM, Blanco-Bose W, Evans M, Aebischer P, Auwerx J, Rinsch C. Urolithin A improves muscle strength, exercise performance, and biomarkers of mitochondrial health in a randomized trial in middle-aged adults. Cell Rep Med. 2022 May 17;3(5):100633. doi: 10.1016/j.xcrm.2022.100633. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Mitopure 1000mg |
| Dietary Supplement |
Mitopure containing softgels |
|
| Placebo | Dietary Supplement | Placebo containing softgels |
|
| 2, 4 months |
| Change in handgrip strength of the non-dominant hand as assessed by Jamar dynamometry from baseline to day 120 between AMAZ-02 groups and placebo | 4 months |
| Change in isokinetic lower body muscle strength as assessed by the Biodex isokinetic dynamometer from baseline to day 120 between AMAZ-02 groups and placebo | 4 months |
| Change in physical performance on the cycle ergometry defined as the time to reach 85% of maximum heart rate from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo | 2, 4 months |
| Change in distance walked in the 6-minute walk test as a measure of aerobic endurance from baseline to day 120 between AMAZ-02 groups and placebo | 4 months |
| Change in gait speed from baseline to day 120 between AMAZ-02 groups and placebo as derived from the 6-minute walk test | 4 months |
| Change in the 30-second chair stand test from baseline to day 120 between AMAZ-02 groups and placebo | 4 months |
| Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's quality of life as assessed by the 36-item short form (SF-36) questionnaire | 4 months |
| Change from baseline to days 60 and from baseline to day 120 between AMAZ-02 groups and placebo in participant's perceived exertion during exercise testing as assessed by the Borg Rating of Perceived Exertion Scale (Scale from 6-20) | 2, 4 months |
| Change from baseline to days 60 and 120 between AMAZ-02 groups and placebo in participant' resting energy expenditure in Kcal/ day via the Cardiocoach CO2 system | 2, 4 months |
| Change in 3-day food records reviewed at baseline and days 60 and 120 | 2, 4 months |
| Change from baseline to day 60 and from baseline to day 120 in serum lipid profile, insulin, and HbA1C between AMAZ-02 groups and placebo | 2, 4 months |
| Change in lean body mass as assessed by dual X-ray absorptiometry (DXA) from baseline to day 120 between AMAZ-02 groups and placebo | 4 months |
| Change in acylcarnitine profile in plasma via Metabolomics assessments from baseline to day 60, and from baseline to day 120 between AMAZ-02 groups and placebo | 2, 4 months |
| Change in plasma muscle function biomarkers (myostatin, follistatin, inflammatory cytokines and mitokines) from baseline to day 60 and from baseline to day 120 between AMAZ-02 groups and placebo | 2, 4 months |
| Change in in vivo mitochondrial gene expression from baseline to day 120 between AMAZ-02 groups and placebo as assessed via microarray performed on muscle biopsy | 4 months |
| Change in the gut microbial diversity at baseline and at day 120 between AMAZ-02 groups and placebo assessed via 16s RNA sequencing performed on fecal samples | 4 months |
| The change in the international physical activity questionnaire score (IPAQ) from baseline to day 120 between AMAZ-02 500mg/d and 1000mg/d and placebo. | 4 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |