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

December 14, 2015 updated by: Jeroen Wouters, InnoSportNL

The Effect of a Potato Based Low-osmolaric Glucose Polymer Drink on 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6816VD
        • InnoSportLab Papendal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
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.
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
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.
1 hour after ingestion of sports drink
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.
During 1 hour after ingestion of sports drink

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InnoSportNL

Collaborators

Avebe U.A.

Investigators

  • Principal Investigator: Jeroen Wouters, Dr. Ir.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 23, 2015

First Posted (Estimate)

March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

December 15, 2015

Last Update Submitted That Met QC Criteria

December 14, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LOGP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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