Clinical trial NCT02401152: A Low-osmolaric Glucose Polymer Drink for Gastric Distress and Running Performance
Official title: The Effect of a Potato Based Low-osmolaric Glucose Polymer Drink on Gastric Distress and Running Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Distress
Running Performance
Lead sponsor: InnoSportNL
Sponsor class: OTHER
Collaborators: name: Avebe U.A.
First posted: 2015-03-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Perceived degree of gastric complaints after consumption of sports drink and running exercise
timeFrame: Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
measure: Finishing time during 10 km running event
timeFrame: Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.
Secondary outcomes:
measure: Rate of gastric emptying
timeFrame: 1 hour after ingestion of sports drink
measure: Blood glucose levels
timeFrame: During 1 hour after ingestion of sports drink
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: InnoSportlab Papendal
state: Gelderland
Study officials:
name: Jeroen Wouters, Dr. Ir.
role: PRINCIPAL_INVESTIGATOR
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