Effects of Probiotics and Nutritional Status on Exercise-Induced Symptoms, and Endurance Performance in Ultra-Endurance Athletes

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes

Conditions
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Ultra-endurance Athletes With Gastrointestinal Symptoms

Intervention / Treatment
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* Dietary Supplement: Oral Rehydration Salts supplemented with L. Rhamnosus GG
* Dietary Supplement: Oral Rehydration Salts only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Ultra-endurance athletes with at least one gastrointestinal symptoms will be administered oral rehydration salts supplemented with L. Rhamnosus GG or oral rehydration salts only for 4 weeks
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Rehydration Salts supplemented with L. Rhamnosus GG<br>a supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides | Dietary Supplement: Oral Rehydration Salts only<br>* A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose<br>|
| Experimental: Oral Rehydration Salts only<br>A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose | Dietary Supplement: Oral Rehydration Salts supplemented with L. Rhamnosus GG<br>* A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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signs and symptoms, digestive, Probiotics, Oral rehydration therapy, Gastrointestinal Microbiome