Ultra-endurance Athletes With Gastrointestinal Symptoms Clinical Trial
Official title:
Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes
| Verified date | February 2021 |
| Source | Istanbul Medeniyet University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Ultra-endurance athletes have been commonly endured extreme conditions during races and training sessions, resulting in exercise-associated clinical symptoms, including gastrointestinal symptoms, dehydration, and elevated oxidative stress. Although these alterations adversely affect sports performance and well-being, there is no certain treatment or consensus on alleviating the exercise-associated clinical symptoms in ultra-endurance athletes. The objective of this study is to determine the effects of oral rehydration salts supplemented with Lactobacillus Rhamnosus GG on exercise-induced gastrointestinal problems, dehydration and oxidative stress in ultra-endurance athletes. Additionally, we aimed to assess the exercise-induced alterations in oxidative stress determined by applying an acute strenuous exercise protocol ((a cycle ergometer (45 min at 65%VO2max) immediately followed by a treadmill test (75% VO2max to exhaustion)) before and after the supplementation period.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | May 15, 2019 |
| Est. primary completion date | May 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 64 Years |
| Eligibility | Inclusion Criteria: - Participants who train at least 15 h per week, - Participants who do not have any metabolic disease, - Have had at least one gastrointestinal symptom determined by using a Gastrointestinal Symptoms Rating Scale and Bristol Stool Chart Form Scale, - Being a non-smoker, - Have participated in at least one ultra-endurance race/event (lasts > 4 hr), - Taking no vitamins, minerals, dietary supplements, antibiotics, and any medication at least during the three months before the study, - (For women) participants with a regular menstrual cycle of physiological length (24-35 days) Exclusion Criteria: - Regular tobacco use - Inability to adhere to any of the study protocol requirements (i.e. alcohol, caffeine consumption, diet control) - Having consumed any supplements and/or medicines for the preceding 3 months period. - (For women) participants in menopause or using oral contraceptives |
| Country | Name | City | State |
|---|---|---|---|
| Turkey | Centre of Athlete Training and Health Research | Ankara |
| Lead Sponsor | Collaborator |
|---|---|
| Istanbul Medeniyet University |
Turkey,
Hoffman MD, Stellingwerff T, Costa RJS. Considerations for ultra-endurance activities: part 2 - hydration. Res Sports Med. 2019 Apr-Jun;27(2):182-194. doi: 10.1080/15438627.2018.1502189. Epub 2018 Jul 28. Review. — View Citation
Hooper LV, Gordon JI. Commensal host-bacterial relationships in the gut. Science. 2001 May 11;292(5519):1115-8. Review. — View Citation
Kekkonen RA, Vasankari TJ, Vuorimaa T, Haahtela T, Julkunen I, Korpela R. The effect of probiotics on respiratory infections and gastrointestinal symptoms during training in marathon runners. Int J Sport Nutr Exerc Metab. 2007 Aug;17(4):352-63. — View Citation
Krabak BJ, Lipman GS, Waite BL, Rundell SD. Exercise-Associated Hyponatremia, Hypernatremia, and Hydration Status in Multistage Ultramarathons. Wilderness Environ Med. 2017 Dec;28(4):291-298. doi: 10.1016/j.wem.2017.05.008. Epub 2017 Aug 7. — View Citation
Lopez AA, Preziosi JP, Chateau P, Auguste P, Plique O. [Digestive disorders and self medication observed during a competition in endurance athletes. Prospective epidemiological study during a championship of triathlon]. Gastroenterol Clin Biol. 1994;18(4) — View Citation
Mach N, Fuster-Botella D. Endurance exercise and gut microbiota: A review. J Sport Health Sci. 2017 Jun;6(2):179-197. doi: 10.1016/j.jshs.2016.05.001. Epub 2016 May 10. Review. — View Citation
Martarelli D, Verdenelli MC, Scuri S, Cocchioni M, Silvi S, Cecchini C, Pompei P. Effect of a probiotic intake on oxidant and antioxidant parameters in plasma of athletes during intense exercise training. Curr Microbiol. 2011 Jun;62(6):1689-96. doi: 10.10 — View Citation
Maughan RJ, Shirreffs SM. Sports Beverages for Optimizing Physical Performance. In: Wilson T., Temple N. (eds) Beverage Impacts on Health and Nutrition. Nutrition and Health. Humana Press, Cham. 2016.
Nocella C, Cammisotto V, Pigozzi F, Borrione P, Fossati C, D'Amico A, Cangemi R, Peruzzi M, Gobbi G, Ettorre E, Frati G, Cavarretta E, Carnevale R; SMiLe Group. Impairment between Oxidant and Antioxidant Systems: Short- and Long-term Implications for Athl — View Citation
Pyne DB. Exercise-induced muscle damage and inflammation: a review. Aust J Sci Med Sport. 1994 Sep-Dec;26(3-4):49-58. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes of the gut microbiome after a 4-week supplementation period | - To assess the profile of gut flora (% abundance of various bacterial phyla, families, genera and species) at baseline and after supplementation in ultra-endurance athletes, using a 16S ribosomal RNA sequencing | Change from Baseline Gut Microbiome at 4 weeks | |
| Secondary | Changes in blood markers of exercise-associated oxidative stress (8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity in plasma) | - Blood samples were collected pre-and post-exercise applied before and after supplementation to evaluate the change in exercise-induced oxidative stress in plasma. Plasma concentrations of 8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity were analysed using ELISA kits. | 4 weeks |