Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Gastrointestinal symptoms during training and competition
研究概览
简要总结
This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete.
Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event.
Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition.
Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84).
The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.
详细描述
The study will recruit ironman triathletes who have qualified for the Kona ironman World-championships in Hawaii. Participants will be allocated into either probiotic (Lab4 Probiotics, Cultech, Port Talbot, Wales, UK) or placebo (Maltodextrin) groups, in a double-blind fashion (Blinded by supplement supplier).
Those recruited into the study will have their training load and gut symptoms monitored for 8-weeks prior to competition via the completion of online questionnaires (previously validated).
Four-weeks prior to competition participants will provide a stool sample for microbiome analysis, they will then proceed to supplement with probiotic or placebo for 4-weeks. 24-h prior to competition they will provide a stool sample as well as providing a sample from the first bowel movement post-race, which will be used for microbiome analysis.
Data will be collected for pre-race and raceday nutrition, as well as outcome measures for raceday performance and gastroitestinal symptoms experienced, again via online questionnaire.
Stool samples will be analysed by an independent laboratory that specialises in microbiome analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study has been blinded by an impartial third party from the company that has provided both the probiotic supplements and the placebo capsules.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-85
- •Qualification for the Kona Ironman World-championships in Hawaii
排除标准
- •Have a current musculoskeletal injury.
- •Currently unwell with cold or flu
- •Have been told they have liver disease
- •Have gastric Ulcer or other gastric/stomach problems
- •Have a condition/disease of the Gut/bowel.
- •Have diagnosed uncontrolled asthma
- •Have kidney problems
- •Have a chronic connective tissue disorder
- •Have suffered cerebrovascular disease such as a stroke
- •Are taking balcofen, methotrexate, tacrolimus and voriconazole, beta-blockers or diuretics drugs
结局指标
主要结局
Gastrointestinal symptoms during training and competition
时间窗: 8-weeks
This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire
Composition of the gut microbiome
时间窗: 4-weeks
This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing
次要结局
- Training volume and intensity(8-weeks)
- Perceived stress(8-weeks)
- Quality of sleep(8-weeks)