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

I

InnoSportNL

Status

Completed

Conditions

Running Performance
Gastric Distress

Treatments

Other: Sports drink 2
Other: Sports drink 1
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02401152
LOGP-001

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

43 participants in 3 patient groups, including a placebo group

Placebo group
Placebo Comparator group
Description:
Sports drink containing maltodextrin
Treatment:
Other: Placebo
Sports drink 1
Active Comparator group
Description:
Sports drink with a specific source of carbohydrates (CHO).
Treatment:
Other: Sports drink 1
Sports drink 2
Active Comparator group
Description:
Sports drink with a specific source of CHO.
Treatment:
Other: Sports drink 2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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