The Effect of a Potato Based Low-osmolaric Glucose Polymer Drink on Gastric Distress and Running Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Perceived degree of gastric complaints after consumption of sports drink and running exercise
研究概览
简要总结
The objective of this study is to investigate whether two newly developed sports drink will affect gastric distress (GD) and running performance (RP) compared to an iso-caloric control drink both in a short and longer distance run. Furthermore, the effect of the newly developed sports drinks on gastric emptying will be investigated.
The study will consist of 3 parts. Firstly, a randomized cross-over design is used for the short distance run and the effects on GD and RP. Secondly, a parallel design is used to study the effects of the drinks on GD and RP during a longer distance run. Thirdly, the gastric emptying tests will be performed in a randomized cross-over design. Participants will be asked to fill in questionnaire on the gastric distress they experience. 40 participants will be enrolled to participate in part 1 and part 2. 10 out of 40 will participate in part 3 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 35 years
- •A BMI between 18.5 and 25 kg*m-2
- •Intermediate level runners with at least 1 year of running experience, performing moderate to intensive running exercise consistently (two or more times per week for a minimum of 30 minutes each time)
排除标准
- •Pregnancy
- •Having diseases, such as diabetes, kidney, liver, lung, or bowel disease, cardiovascular disease, or mental illness
- •Abuse of alcohol (>20 alcoholic consumptions per week)
- •Use of medication and/or drugs
- •Smoking/having smoked in the last six months
- •Participating in any scientific intervention providing a treatment potentially interfering with this study's treatment (to be decided by the researchers)
- •Allergic to one of the components present in the drinks, including milk (incl. lactose), soy and gluten
结局指标
主要结局
Perceived degree of gastric complaints after consumption of sports drink and running exercise
时间窗: Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
Quantified as the score for the perceived degree of experiencing 7 different gastric complaints on a VAS. The total score for gastric distress and the scores for each different gastric complaint will be analysed separately for the three different time points (before, during and after exercise). The total score is the sum of the scores on the separate complaints.
Finishing time during 10 km running event
时间窗: Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.
次要结局
- Rate of gastric emptying(1 hour after ingestion of sports drink)
- Blood glucose levels(During 1 hour after ingestion of sports drink)
研究者
Jeroen Wouters
Dr. Ir.
InnoSportNL