The Effect of Probiotics on the Relationship Between the Gut Microbiota and Gastrointestinal Symptoms During Endurance Exercise'
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Performance maximal running maximal incremental exercise test
Study Overview
Brief Summary
A double-blind randomized, placebo-controlled study will be performed with experienced endurance athletes to assess the effect of probiotics supplementation on the occurrence and intensity of the gastrointestinal symptoms, on performance and on the composition and function of the gut microbiota. The duration of the supplementation period, with Ecologic® PERFORMANCE supplements, is fourteen weeks. Standardized maximum exercise tests on a treadmill are performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the performance tests, the load is first submaximal for 1 hour, after which a time trial of 30 minutes will be performed. The measurements before and after the supplementation period are performed on individual days with at least 48 hours of relative rest in between. During the supplementation period, training diaries, a Profile of Mood States (POMS) questionnaire and a few questionnaires about dietary habits will be completed.
Detailed Description
Rationale: Endurance exercise, such as running a marathon, is becoming increasingly popular. In addition to the many positive health effects of endurance exercise, it can also be accompanied by gastrointestinal symptoms. For example, around 30-90% of runners suffer from gastrointestinal symptoms during or in the hours after intensive/endurance running. The occurrence of gastrointestinal symptoms is probably due to the redistribution of blood volume, resulting in less blood supply to the digestive tract and a less functioning intestinal barrier. Because the intestinal barrier functions less, endotoxins can enter the bloodstream and cause inflammatory reactions. Running in the heat causes extra redistribution of the blood volume, because extra blood is needed for cooling of the body. It is known that the gut microbiota affect food digestion, but also the functioning of the cells that line the intestinal wall and the connections between these cells. It is possible that runners with gastrointestinal symptoms face a different composition of the gut microbiota and / or metabolites during endurance exercise compared to runners without any complaints, as a result of which the gut barrier functions less well and problems may occur. Many positive effects have been attributed to the use of probiotics in general. Amongst which, the reduction of gastrointestinal symptoms during endurance exercise, probably due to improvement in intestinal permeability. Hence, the main goal of our research project is to investigate whether the chance of and/or intensity of gastrointestinal symptoms during endurance exercise and the exercise performance can be influenced by probiotics supplementation in trained endurance athletes. This will be studied in relation to the composition of the gut microbiota and / or metabolites.
Objective:
Primary Objective:
Can the chance at and/or intensity of gastrointestinal symptoms during exercise be influenced by probiotics supplementation in trained endurance athletes who experience these symptoms and can performance be enhanced? Secondairy Objective: Can the composition and function of the gut microbiota of trained athletes that experience gastrointestinal symptoms during exercise be positively influenced by probiotics supplementation?
Study design: A double-blind randomized placebo-controlled trial will be performed to investigate the effect of 14 weeks probiotics supplementation with Ecologic® PERFORMANCE supplements. Standardized maximal incremental exercise tests will be performed before and after the supplementation period, as well as two performance tests (before) and one performance test (after). During the supplementation period training diaries, a POMS questionnaire and some questionnaires about food habits will be completed, a food diary and Food Frequency Questionnaire (FFQ).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Dutch nationality; maximal oxygen uptake (V ̇O_2max) ≥ 45 mL·kg-1·min-1 (based on an incremental exercise test you are considered trained);
- •an average training frequency of at least three times per week;
- •a low risk profile based on a health-history form (the form is attached to the participant information letter);
- •occurrence of exercise-induced gastrointestinal symptoms.
Exclusion Criteria
- •a diagnosis of gastrointestinal disorders (e.g. Crohn's disease, celiac disease, diagnosed with irritable bowel syndrome);
- •use of antidepressants in the 6 months prior to the start of the study;
- •use of antibiotics, antivirals, antifungals, antiparasitic agents, prebiotics/probiotics supplements (foods are allowed) in the 6 months prior to the start of the study.
Outcomes
Primary Outcomes
Performance maximal running maximal incremental exercise test
Time Frame: Before and after 14 weeks of supplementation
Maximum speed on a maximal rincremental exercise test
Performance maximal running
Time Frame: Before and after 14 weeks of supplementation
Distance in km on a 30 minute running time trial, preceded by two times 30 minutes submaximal exercise.
Gastrointestinal symptoms
Time Frame: Before and after 14 weeks of supplementation
Severity (scale 1-10) of gastrointestinal symptoms during and directly after a running performance test. (1 = none and 10 = worst symptoms ever)
Secondary Outcomes
- The influence of probiotics on the composition of the gut microbiota in trained endurance athletes that experience gastrointestinal symptoms.(Before and after 14 weeks of supplementation)
- The influence of probiotics on the composition of the gut metabolites in trained endurance athletes that experience gastrointestinal symptoms.(Before and after 14 weeks of supplementation)
Investigators
Karlijn te Poele
MSc.
Hogeschool Leiden, University of Applied Science