Effects of Dietary Supplementation With ReWin(d) on the Recovery of Young Athletes Suffering From Delayed-Onset Muscle Soreness Induced by Acute Exercice: A Pilot Randomized, Double-blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effects of ReWin(d) on muscle recovery induced by physical exercise
研究概览
简要总结
The study will assess the recovery and performance of young athletes suffering from muscle damage induced by physical exercise. Model by comparing the safety and efficacy of ReWin(d) supplemention during 4 weeks to placebo over 72 hours post exercice.
详细描述
Double-blind, randomized, placebo controlled, parallel group, pilot safety and efficacy study.
40 healthy young male athetes were randomly assigned to the ReWin(d) or Placebo group. After 4 weeks supplementation (either 2 g daily of ReWin(d) capsules or placebo capsules). the participants were subjected to a 1 hour plyometric exercise session to induce DOMS. At 0 hours, 24 hours, 48 hours and 72 hours post exercise, the volunteers have been assessed to determine: (i) pain perception, (ii) fatigue rate, (iii) sport performance (effectiveness of a jump) and (iv) muscle damage and inflammation by I-R thermography and biomarkers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •> 18 years old
- •Young athletes
- •Training at least 3 times per week
- •Agree not to initiate any new exercise or diet programs during the entire study period
- •Agree not to change their current diet or exercise program during the entire study period
- •Agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment for the duration of the trial.
排除标准
- •Previous history of upper extremity injury or knee joint pain
- •Use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study
- •Daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
- •Antibiotic use in past 3 months
- •Chronic disease
研究组 & 干预措施
ReWin(d)
Subjects have to take ReWin(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks + 3 days after acute exercice
干预措施: Polyherbal supplement: ReWin(d) vs Placebo (Dietary Supplement)
placebo
Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks + 3 days after acute exercice
干预措施: Polyherbal supplement: ReWin(d) vs Placebo (Dietary Supplement)
结局指标
主要结局
Effects of ReWin(d) on muscle recovery induced by physical exercise
时间窗: Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS
Sport performance (effectiveness of a jump) after exercise-induced muscle damage
次要结局
- Effects of ReWin(d) on pain perception induced by physical exercise(Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session)
- Effects of ReWin(d) on fatigue rate induced by physical exercise(Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session)
- Effects of ReWin(d) on Gut Microbiota(Change from baseline dose after 4 weeks of intervention)
- Effects of ReWin(d) on muscle damage induced by physical exercise(Change from baseline at 0 hours, 24 hours, 48 hours and 72 hours post plyometric exercises session to induce DOMS)
研究者
Margarita Pérez Ruiz
Principal Investigator. Full Profesor in Physical Activity and Sport. Exercise physiology.
European University of Madrid