NCT07231783招募中不适用
A Confirmatory, Randomised, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Effects of a Dietary Supplement Containing Urolithin A (Mitopure®) on Muscle Strength and Performance in Healthy Middle-Aged Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Amazentis SA
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Maximum isokinetic knee flexion strength
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, parallel study to assess the effects of Urolithin A (Mitopure®) supplementation on muscle strength and performance in healthy middle-aged adults. Participants will be randomized to consume Mitopure® (500 mg), Mitopure® (1000 mg), or placebo once daily for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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/m
- •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-h 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-h before exercise as per study guidelines.
- •8. Willing to consume the Study Product daily for the duration of the study.
排除标准
- •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:
- •a. 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. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
- •b. Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- •c. Sexual partner(s) is/are exclusively female.
- •d. 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.
- •e. 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:
- •a. Major illness/surgery in the 12-weeks prior to screening
- •b. Diagnosed cardiovascular disease (NHYA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmia, uncontrolled hypertension)
- •c. Diagnosed liver disease (cirrhosis, end stage liver disease)
- •d. Diagnosed kidney disease (stage 3b or 4 chronic kidney disease, or kidney failure)
- •e. Diagnosed gastrointestinal disease (IBS/IBD, diarrhoea, Acid Reflux)
- •f. Uncontrolled thyroid conditions
- •g. Uncontrolled diabetes
- •h. Metallic implants
- •i. 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:
- •a. Statins or other medications known to impair mitochondrial function.
- •b. Anxiolytics, antidepressants, sedative hypnotics (in the 8 weeks prior to visit 1)
- •c. Antipsychotics, monoamine Oxidase Inhibitors (in the 8 weeks prior to visit 1)
- •d. Oral anti- infective (antibiotics, antivirals, antifungals) for acute infections (in the 12-weeks prior to visit 1)
- •e. Proton pump inhibitors (PPIs) (in the 4 weeks prior to visit 1)
- •f. Corticosteroids (> 5mg per day in the past 4 weeks prior to visit 1)
- •g. GLP-1 agonists (in the 8 weeks prior to visit 1)
- •11. Current or recent (in the past 6-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements 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 supplements include:
- •a. Mitopure® containing supplements
- •b. Supplements for muscle strengthening/building or mitochondrial boosting supplements (e.g. high protein, Vitamin B3 [and precursors], L-carnitine, CoQ10, NAD+, resveratrol)
- •12. Blood donation in the 8-weeks prior to screening.
- •13. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- •14. Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study (physical or muscle performance), the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
结局指标
主要结局
Maximum isokinetic knee flexion strength
时间窗: 6 months
Change in maximum isokinetic knee flexion strength between Mitopure® groups and placebo measured by Biodex dynamometry (unit: Nm)
次要结局
- Maximum isokinetic knee flexion strength(4 months)
- Maximum isokinetic knee extension strength(4, 6 months)
- Maximum isometric knee flexion strength(4, 6 months)
- Maximum isometric knee extension strength(4, 6 months)
- Maximum shoulder flexion strength(4, 6 months)
- Maximum shoulder extension strength(4, 6 months)
- Physical performance (vertical jump)(4, 6 months)
- Body composition (lean mass)(4, 6 months)
研究者
研究点 (2)
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