NCT04664361已完成不适用
Randomized, Double-blind, Placebo-controlled Clinical Trial of Nicotinamide Mononucleotide on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Seneque SA
- 入组人数
- 131
- 试验地点
- 2
- 主要终点
- Evolution of muscle recovery
研究概览
简要总结
The purpose of this study is to evaluate the effect of NMN supplementation (250 and 500 mg/day over 38 days) compared to placebo in healthy volunteers with moderate physical activity on muscle recovery, physical capacity, cardiorespiratory recovery, the perception of the arduousness of the effort, the variation in blood lactate levels before and after physical exercise, the perception of the intensity of post-exercise muscle pain (cramps), the body composition and Nicotinamide-Adenine Mononucleotide (NAD+) level in blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index ranging from 20 to 28 kg/m2(bounds included);
- •Body weight between of 70 kg to 100 kg (including limits);
- •Able to provide written informed consent to participate;
- •Having a moderate level of physical activity according to the Global Physical Activity Questionnaire (GPAQ);
- •Having a sport practice involving endurance or split races (including collective or individual sports) or cycling.
- •Agreeing not to change their physical activity habits throughout the study;
排除标准
- •Having a mental state that does not allow them to give free and informed consent to participate in the study;
- •Being taking regularly or have taken within the last month any medication or dietary supplement that may increase endurance, recovery, or physical capacity. In particular, the following drugs are strictly prohibited: beta-2 agonists such as salbutamol (Ventolin®), terbutaline (Bricanyl®), fenoterol (Berotec®), salmeterol (Serevent®) and formoterol (Foradil®) as well as corticosteroids;
- •Having history of a recent (less than 3 months) lower extremity muscle injury;
- •Presenting a depressive syndrome;
- •Presenting, in the opinion of the investigator, any symptomatology, pathology or cardiovascular risk factors that are incompatible with the conduct of the study or with the performance of a stress test or that could influence the results of the study, and in particular: 1) an abnormal resting and/or stress ECG at the inclusion visit according to the investigator; 2) presence of abnormalities in the lipid balance (Total Cholesterol, Triglycerides, HDL, LDL), blood glucose, and/or hemodynamic parameters;
- •Presenting an abnormal biological balance (Creatinine, Uric acid, Troponin, Alanine aminotransferase / Aspartate aminotransferase, Lactate dehydrogenase, Creatine Kinase, C-reactive protein, Transferrin, Bilirubin, Gamma Glutamyl transpeptidase, Cholesterol (EAL), Glycemia, Ionogram, Alkaline phosphatase );
- •Being not be compliant with the constraints imposed by the protocol;
- •Having an allergy or a contraindication to the components of the studied products;
- •Being already involved in another clinical trial or being in the exclusion period of a previous clinical trial;
- •Being unable to understand, speak and read French fluently;
- •Being not affiliated with a health insurance company;
- •Being vulnerable persons or persons deprived of liberty by a judicial or administrative decision;
- •Consuming illegal psychotropic substances or having an alcohol consumption of more than 2 glasses of alcohol/wine per day.
结局指标
主要结局
Evolution of muscle recovery
时间窗: before and after 21 and 38 days of treatment
Wingate Anaerobic Test (WANT) preformed post-endurance test (at 85% maximum aerobic speed)
次要结局
- Changes in physical capacity(before and after 21 and 38 days of treatment)
- Changes in cardiorespiratory recovery(before and after 21 and 38 days of treatment)
- Changes in the body composition(before and after 21 and 38 days of treatment)
- Changes blood NAD+ levels(before and after 21 and 38 days of treatment)
- Changes in the perception of the arduousness of the effort(before and after 21 and 38 days of treatment)
- Changes in the perception of the intensity of post-exercise muscle pain (cramps)(before and after 21 and 38 days of treatment)
- Changes in blood lactate levels before and after physical exercise(before and after 21 and 38 days of treatment)
研究者
研究点 (2)
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