Controlled, Randomized, Parallel, Double-blind Study of the Effect of NUTRALYS® Pea Protein Supplementation Versus Whey Protein and Placebo on the Muscle Mass and Strength of Volunteers Engaged in Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Biceps brachial thickness measured using ultrasonography
研究概览
简要总结
this clinical trial would try to confirm whether NUTRALYS®, a fast pea protein with an intermediate profile, rich in leucines and other essential amino acids, can significantly enhance muscle mass gain during strength training. This study will compare the efficacy of NUTRALYS® to a reference product. If the results of the study demonstrate a significant improvement in relation to the placebo, not inferior to that of whey, NUTRALYS® could be considered as an alternative to sports nutrition products, to which many people are intolerant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects from 18 to 35 years of age:
- •engaged in moderate or occasional sports activity;
- •having given their written informed consent;
- •in gainful employment or a student;
- •in possession of a medical certificate of fitness for sports
排除标准
- •Subject already engaged in regular sports or training increasing muscle strength or volume in the upper limbs and particularly the biceps brachial;
- •Subject engaged or having engaged in the last 6 months in weight training more than once a week;
- •Subject having had a muscle injury in the 3 months prior to the study;
- •Asthmatic subject liable to be administered corticosteroids;
- •Subject taking part in another trial;
- •Subject with a known hypersensitivity to whey or pea proteins;
- •Subject deprived of their freedom for administrative, medical or legal reasons or not in possession of the legal or ethical capacity to enter into a contract due to cognitive function impairment;
- •Subject liable not to comply with the constraints required by the protocol;
- •Subject not covered by health insurance;
- •Subject having taken in the previous month or currently taking: medication, a dietary supplement, sports drink, food for particular nutritional uses or functional foods, of any kind, liable or described as liable to increase physical performance and notably to increase muscle mass;
- •Subject taking anabolic protein or corticosteroid treatment;
- •Subject on a high-protein diet.
结局指标
主要结局
Biceps brachial thickness measured using ultrasonography
时间窗: 12 weeks after first ingestion
biceps muscle thickness measured in millimeter using images from ultrasonography
次要结局
- Elbow flexor strength(12 weeks after first ingestion)
- Biceps circumference(12 weeks after first ingestion)
- body weight(12 weeks after first ingestion)
- tolerance(12 weeks after first ingestion)
- muscle force(12 weeks after first ingestion)
研究者
Nicolas Babault
Scientific and sports coordinators
University of Burgundy