A Low-osmolaric Glucose Polymer Drink for Gastric Distress and Running Performance
14. desember 2015 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
43
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Gelderland
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Arnhem, Gelderland, Nederland, 6816VD
- InnoSportLab Papendal
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 35 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo group
Sports drink containing maltodextrin
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iso-caloric sports drink with maltodextrin as CHO source
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Aktiv komparator: Sports drink 1
Sports drink with a specific source of carbohydrates (CHO).
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Sports drink with a specific source of CHO.
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Aktiv komparator: Sports drink 2
Sports drink with a specific source of CHO.
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Sports drink with a specific source of CHO
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived degree of gastric complaints after consumption of sports drink and running exercise
Tidsramme: Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
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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.
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Approximately 10-20 minutes for the 3 km and 40-60 minutes for the 10 km.
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Finishing time during 10 km running event
Tidsramme: Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.
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Depending on the speed of the participant, an average time frame of 40-60 minutes after starting the run is expected.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Rate of gastric emptying
Tidsramme: 1 hour after ingestion of sports drink
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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.
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1 hour after ingestion of sports drink
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Blood glucose levels
Tidsramme: During 1 hour after ingestion of sports drink
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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.
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During 1 hour after ingestion of sports drink
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jeroen Wouters, Dr. Ir.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- Moses FM. The effect of exercise on the gastrointestinal tract. Sports Med. 1990 Mar;9(3):159-72. doi: 10.2165/00007256-199009030-00004.
- 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.
- 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.
- 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. Erratum In: J Am Diet Assoc. 2013 Dec;113(12):1759.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2015
Primær fullføring (Faktiske)
1. september 2015
Studiet fullført (Faktiske)
1. september 2015
Datoer for studieregistrering
Først innsendt
9. mars 2015
Først innsendt som oppfylte QC-kriteriene
23. mars 2015
Først lagt ut (Anslag)
27. mars 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
15. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- LOGP-001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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