Muscle strength in healthy middle-aged adults. Other
Conditions
Interventions
Participants will be randomized with a list generated by a statistician not involved in the conduct of the study to consume a daily dose of either:
1. Mitopure (Urolithin A dose: 500 mg), or
2. Mitopu
Sponsors
Amazentis (Switzerland)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Be able to give written informed consent 2. Be between 40 to 65 years of age, inclusive 3. Has a BMI between 25.0 and 34.9 kg/m² 4. Low physical activity levels as assessed by the International Physical Activity Questionnaire (IPAQ) 5. Participants with low VO2 peak (defined as <35 mL/kg/min via the ergometer prior to baseline) 6. Willing to avoid exercising 48 hours prior to study visits and maintain low physical activity status for the duration of the study 7. Willing to avoid caffeine and other stimulants (e.g., energy drinks) 12 hours before exercise as per study guidelines 8. Willing to consume the Study Product daily for the duration of the study
Exclusion criteria
Exclusion criteria: 1. Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding 2. Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below: 2.1 Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely 2.2 Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant 2.3 Sexual partner(s) is/are exclusively female 2.4 Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study 2.5 Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study 3. Participants with history of drug and/or alcohol abuse at the time of enrolment (drinks more than nationally recommended units per week: >11 units for women; >17 units for men; alcohol/substance abuse disorder) 4. Participants consuming large quantities of pomegranate juice or walnuts or frequent consumers of raspberries, strawberries or cloudberries (2-week washout) 5. Chronic nicotine use 6. Participants who are unable to swallow capsules 7. Is hypersensitive to or has dietary restrictions for any of the components of the Study Product e.g., gelatine 8. Unstable body weight or recent participation in a weight loss program (within 12 weeks prior to screening) 9. Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include: 9.1 Major illness/surgery in the 12 weeks prior to screening 9.2 Diagnosed cardiovascular disease (NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmia, uncontrolled hypertension) 9.3 Diagnosed liver disease (cirrhosis, end stage liver disease) 9.4 Diagnosed kidney disease (stage 3b or 4 chronic kidney disease, or kidney failure) 9.5 Diagnosed gastrointestinal disease (IBS/IBD, diarrhoea, acid reflux) 9.6 Uncontrolled thyroid conditions 9.7 Uncontrolled diabetes 9.8 Metallic implants 9.9 Conditions requiring chemotherapy or immunotherapy 10. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include: 10.1 Statins or other medications known to impair mitochondrial function 10.2 Anxiolytics, antidepressants, sedative hypnotics (in the 8 weeks prior to Visit 1) 10.3 Antipsychotics, monoamine oxidase inhibitors (in the 8 weeks prior to Visit 1) 10.4 Oral anti-infectives (antibiotics, antivirals, antifunga
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum isokinetic knee flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum isokinetic knee flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline and 4 months. 2. Maximum isokinetic knee extension strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 3. Maximum isometric knee flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 4. Maximum isometric knee extension strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 5. Maximum shoulder flexion strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 6. Maximum shoulder extension strength will be measured by Biodex dynamometry (unit: Nm) at baseline, 4, and 6 months. 7. Body composition (lean mass) will be measured by dual-energy X-ray absorptiometry (unit: kg) at baseline, 4, and 6 months. 8. Physical performance (vertical jump) will be measured by maximum vertical jump height (unit: cm) at baseline, 4, and 6 months. Other Pre-Specified (Tertiary) Outcome Measures 9. Cardiovascular fitness (VO2max) will be measured by a graded exercise test (unit: mL/kg/min) at baseline, 4, and 6 months. 10. Physical capacity (time to exhaustion) will be measured by time to exhaustion during the graded exercise test (unit: minutes) at baseline, 4, and 6 months. 11. Physical capacity (maximum cycling distance) will be measured by maximum cycling distance during the graded exercise test (unit: meters) at baseline, 4, and 6 months. 12. Physical performance (30-second chair stand) will be measured by the 30-second chair stand test (unit: repetitions) at baseline, 4, and 6 months. 13. Physical performance (6-minute walk test) will be measured by the 6-minute walk test (unit: meters) at baseline, 4, and 6 months. 14. Physical performance (timed up-and-go) will be measured by the timed up-and-go test (unit: seconds) at baseline, 4, and 6 months. 15. Blood acylcarnitine level will be measured using blood sample analysis a | — |
Countries
Ireland
Contacts
Public ContactBrad Currier
Outcome results
None listed