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

Not Applicable

Completed

• Conditions: Ultra-endurance Athletes With Gastrointestinal Symptoms

• Registration Number: NCT04779281
• Lead Sponsor: Istanbul Medeniyet University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-27
• Last Update Submitted: 2021-02-27
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes of the gut microbiome after a 4-week supplementation period	Change from Baseline Gut Microbiome at 4 weeks	- 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

Secondary Outcome Measures

Name	Time	Method
Changes in blood markers of exercise-associated oxidative stress (8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity in plasma)	4 weeks	- 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.

Trial Locations

Locations (1)

Centre of Athlete Training and Health Research; 🇹🇷 Ankara, Turkey