NCT02401152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

December 15, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

March 9, 2015

Last Update Submit

December 14, 2015

Conditions

Gastric DistressRunning Performance

Outcome Measures

Primary Outcomes (2)

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

    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

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

Secondary Outcomes (2)

  • Rate of gastric emptying

    1 hour after ingestion of sports drink

  • Blood glucose levels

    During 1 hour after ingestion of sports drink

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Sports drink containing maltodextrin

Other: Placebo

Sports drink 1

ACTIVE COMPARATOR

Sports drink with a specific source of carbohydrates (CHO).

Other: Sports drink 1

Sports drink 2

ACTIVE COMPARATOR

Sports drink with a specific source of CHO.

Other: Sports drink 2

Interventions

Sports drink 1OTHER

Sports drink with a specific source of CHO.

Sports drink 1
Sports drink 2OTHER

Sports drink with a specific source of CHO

Sports drink 2
PlaceboOTHER

iso-caloric sports drink with maltodextrin as CHO source

Placebo group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InnoSportlab Papendal

Arnhem, Gelderland, 6816VD, Netherlands

Location

Related Publications (16)

  • Leiper JB, Aulin KP, Soderlund K. Improved gastric emptying rate in humans of a unique glucose polymer with gel-forming properties. Scand J Gastroenterol. 2000 Nov;35(11):1143-9. doi: 10.1080/003655200750056600.

    PMID: 11145284BACKGROUND

  • Takii H, Takii Nagao Y, Kometani T, Nishimura T, Nakae T, Kuriki T, Fushiki T. Fluids containing a highly branched cyclic dextrin influence the gastric emptying rate. Int J Sports Med. 2005 May;26(4):314-9. doi: 10.1055/s-2004-820999.

    PMID: 15900642BACKGROUND

  • Stephens FB, Roig M, Armstrong G, Greenhaff PL. Post-exercise ingestion of a unique, high molecular weight glucose polymer solution improves performance during a subsequent bout of cycling exercise. J Sports Sci. 2008 Jan 15;26(2):149-54. doi: 10.1080/02640410701361548.

    PMID: 17852670BACKGROUND

  • Rehrer NJ, Brouns F, Beckers EJ, ten Hoor F, Saris WH. Gastric emptying with repeated drinking during running and bicycling. Int J Sports Med. 1990 Jun;11(3):238-43. doi: 10.1055/s-2007-1024799.

    PMID: 2373584BACKGROUND

  • Moses FM. The effect of exercise on the gastrointestinal tract. Sports Med. 1990 Mar;9(3):159-72. doi: 10.2165/00007256-199009030-00004.

    PMID: 2180030BACKGROUND

  • de Oliveira EP, Burini RC. Food-dependent, exercise-induced gastrointestinal distress. J Int Soc Sports Nutr. 2011 Sep 28;8:12. doi: 10.1186/1550-2783-8-12.

    PMID: 21955383BACKGROUND

  • Ploutz-Snyder L, Foley J, Ploutz-Snyder R, Kanaley J, Sagendorf K, Meyer R. Gastric gas and fluid emptying assessed by magnetic resonance imaging. Eur J Appl Physiol Occup Physiol. 1999 Feb;79(3):212-20. doi: 10.1007/s004210050498.

    PMID: 10048625BACKGROUND

  • Rodriguez NR, DiMarco NM, Langley S; American Dietetic Association; Dietitians of Canada; American College of Sports Medicine: Nutrition and Athletic Performance. Position of the American Dietetic Association, Dietitians of Canada, and the American College of Sports Medicine: Nutrition and athletic performance. J Am Diet Assoc. 2009 Mar;109(3):509-27. doi: 10.1016/j.jada.2009.01.005.

    PMID: 19278045BACKGROUND

  • American Dietetic Association; Dietitians of Canada; American College of Sports Medicine; Rodriguez NR, Di Marco NM, Langley S. American College of Sports Medicine position stand. Nutrition and athletic performance. Med Sci Sports Exerc. 2009 Mar;41(3):709-31. doi: 10.1249/MSS.0b013e31890eb86.

    PMID: 19225360BACKGROUND

  • Murray R, Bartoli W, Stofan J, Horn M, Eddy D. A comparison of the gastric emptying characteristics of selected sports drinks. Int J Sport Nutr. 1999 Sep;9(3):263-74. doi: 10.1123/ijsn.9.3.263.

    PMID: 10477362BACKGROUND

  • Maughan RJ, Leiper JB. Limitations to fluid replacement during exercise. Can J Appl Physiol. 1999 Apr;24(2):173-87. doi: 10.1139/h99-015.

    PMID: 10198143BACKGROUND

  • Rowlands DS, Wallis GA, Shaw C, Jentjens RL, Jeukendrup AE. Glucose polymer molecular weight does not affect exogenous carbohydrate oxidation. Med Sci Sports Exerc. 2005 Sep;37(9):1510-6. doi: 10.1249/01.mss.0000177586.68399.f5.

    PMID: 16177602BACKGROUND

  • Zhu Y, Hsu WH, Hollis JH. The impact of food viscosity on eating rate, subjective appetite, glycemic response and gastric emptying rate. PLoS One. 2013 Jun 20;8(6):e67482. doi: 10.1371/journal.pone.0067482. Print 2013.

    PMID: 23818981BACKGROUND

  • Siegel JA, Krevsky B, Maurer AH, Charkes ND, Fisher RS, Malmud LS. Scintigraphic evaluation of gastric emptying: are radiolabeled solids necessary? Clin Nucl Med. 1989 Jan;14(1):40-6. doi: 10.1097/00003072-198901000-00011.

    PMID: 2714039BACKGROUND

  • Chang TM, Passaro E Jr, Shain LR, Chen WL. Physical properties of starch meals in vivo and in vitro and their influence on gastric emptying and oral glucose tolerance test. Nutrition. 1991 Nov-Dec;7(6):410-6.

    PMID: 1802230BACKGROUND

  • Mourot J, Thouvenot P, Couet C, Antoine JM, Krobicka A, Debry G. Relationship between the rate of gastric emptying and glucose and insulin responses to starchy foods in young healthy adults. Am J Clin Nutr. 1988 Oct;48(4):1035-40. doi: 10.1093/ajcn/48.4.1035.

    PMID: 3048076BACKGROUND

Study Officials

  • Jeroen Wouters, Dr. Ir.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ir.

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 27, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

December 15, 2015

Record last verified: 2015-12

Locations

NL(1)