Cocoa Intake for the Prevention of Gastrointestinal Problems in Athletes: Effects on Oxidative Stress, Inflammation, Microbiota and Sports Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Measurement of fat mass
研究概览
简要总结
Athletes consume an extra of nutritional supplements every day with the purpose of improving their athletic performance, sometimes without being aware of their health. Cocoa could be a good nutritional supplement for athletes without causing them adverse effects. One of the most common health concerns in athletes are gastrointestinal problems. The cause of these problems seem to be a compendium of physiological and mechanical causes that are altered due to nutritional factors. Currently, there is no assay in which a nutritional intervention study has been proposed over time of training, in order to improve the gastrointestinal problems associated with the performance of physical exercise.
详细描述
The objective of this project is to investigate the benefits of daily consumption of cocoa in endurance athletes in:
A) Gastrointestinal problems associated with exercise. B) Reinforcement of the gastrointestinal barrier. C) Parameters of inflammation and oxidative stress. D) Sports performance. E) Body composition
The starting hypothesis of this project is based on the fact that daily cocoa consumption could improve the gastrointestinal symptoms associated with resistance exercise. Cocoa decreases the symptoms associated with splenic hypovolemia and strengthens the gastrointestinal epithelial barrier increasing the presence of Lactobacillus spp. and Bifidobacterium spp. in the intestinal microbiota.
A randomized, blinded, parallel placebo controlled intervention study will be carried out in endurance athletes who train in the sports facilities of the European University of Madrid. The number of male athletes for the study will be 56 (28 in each experimental group), all of them aimed at competition with an age between 18 and 40 years and an aerobic power consumption of oxygen greater than or equal to 55 mL / kg / min). The calculation of the sample size has been made selecting with a significance level alpha = 0.05 and a power (beta) of 0.90 for a 2-tailed analysis, taking into account we want to detect a difference of at least 15% in the improvement of the gastrointestinal symptoms, that the standard detected deviation in the questionnaire to be used, in previous studies, is 1.5 points out of 9 and that the expected proportion of losses is 15%.
Before and after the intervention, the athletes will do a test in which we will measure their maximum aerobic capacity. This will be done in the facilities of Europea University of Madrid where there is available a rolling belt. Also, they will do a second test in which we will measure the time they spend running a kilometer at the maximum speed. Body composition will be evaluated by dual-energy X-ray absorptiometry (DEXA). Blood, urine and feces samples will be required before and after the physical tests. Blood and urine samples will be collected in the morning while the feces samples will be collected the day before. The biological samples will be frozen at -80ºC until analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Cocoa and maltodextrin (placebo) are provided in identical sachets which are identified just with the letters A and B.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years
- •Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min
排除标准
- •Intake of antibiotics (3 months before the trial) or any chronical medication.
- •Intake of probiotics, prebiotics or any type of food or ergogenic supplements.
- •To be vegetarian or vegan
- •Have documented gastrointestinal diseases (ulcers, irritable bowel, ulcerative colitis, Crohn's disease, etc.).
- •Previous gastrointestinal surgeries or any disease diagnosed at the time of inclusion in the study
结局指标
主要结局
Measurement of fat mass
时间窗: Fat mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention
Energy X-ray absorptiometry (DEXA ).
次要结局
- Indicators of gastrointestinal barrier.(Plasmatic LPS will be analyzed at the beginning and at the end of the 10-week intervention.)
- Sport performance test.(Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention)
- Change in eating habits.(Lifestyle will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention.)
- Measurement of the parameters of inflammation.(Plasma cytokines will be analyzed at the beginning and at the end of the 10-week intervention.)
- Measurement of lean mass(Lean mass will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention)
- Sport performance test 2.(Sport performance will be analyzed at the beginning (baseline dose) and after 10 weeks of intervention)
- Change in Gut Microbiota(Gut microbiota will be analyzed at the beginning (basiline dose) and after 10 weeks of intervention.)
- Modification from baseline of gastrointestinal symptoms at 10 weeks(The questionnaire for the evaluation of gastrointestinal symptoms will be given to the athletes at the beginning and at the end of the 10-week intervention.)
- Change from baseline of oxidative stress parameters .(Nitric oxide will be analyzed at the beginning and at the end of the 10-week intervention.)
研究者
Mar Larrosa
Tenure Professor
Universidad Europea de Madrid