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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InnoSportNL

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avebe U.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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