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Completed

NCT Number: NCT02401152

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

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.

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Key information

Conditions

Gastric Distress Running Performance

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

InnoSportlab Papendal

Arnhem, Gelderland, 6816VD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sports drink 1

Other

Sports drink with a specific source of CHO.

Sports drink 2

Other

Sports drink with a specific source of CHO

Placebo

Other

iso-caloric sports drink with maltodextrin as CHO source

Primary outcomes

  1. Perceived degree of gastric complaints after consumption of sports drink and running exercise

    Time frame: 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.

  2. Finishing time during 10 km running event

    Time frame: Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.

Secondary outcomes

  1. Rate of gastric emptying

    Time frame: 1 hour after ingestion of sports drink

    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.

  2. Blood glucose levels

    Time frame: During 1 hour after ingestion of sports drink

    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.

Sponsors and collaborators

Lead sponsor

InnoSportNL

Other

Collaborators

  • Avebe U.A.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2015
Registry last updated
Dec 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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