A Low-osmolaric Glucose Polymer Drink for Gastric Distress and Running Performance

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of a Potato Based Low-osmolaric Glucose Polymer Drink on Gastric Distress and Running Performance

Conditions
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Gastric Distress, Running Performance

Intervention / Treatment
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* Other: Sports drink 1
* Other: Sports drink 2
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Sports drink containing maltodextrin | Other: Placebo<br>* iso-caloric sports drink with maltodextrin as CHO source<br>|
| Active Comparator: Sports drink 1<br>Sports drink with a specific source of carbohydrates (CHO). | Other: Sports drink 1<br>* Sports drink with a specific source of CHO.<br>|
| Active Comparator: Sports drink 2<br>Sports drink with a specific source of CHO. | Other: Sports drink 2<br>* Sports drink with a specific source of CHO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived degree of gastric complaints after consumption of sports drink and running exercise | 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. | Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km. | 
| Finishing time during 10 km running event |  | Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of gastric emptying | During 1 hour after ingestion of the sports drink, subjects will breath into a specific bag which will be analysed for the presence of C13 on specific time points. The decrease of C13 in the exhaled air is a measurement for gastric emptying time. | 1 hour after ingestion of sports drink | 
| Blood glucose levels | On specific time points within 1 hour after ingestion of the sports drink, blood glucose levels will be determined to calculate area under the curve for the different sport drinks. | During 1 hour after ingestion of sports drink |