Clinical trial NCT04779281: Effects of Probiotics and Nutritional Status on Exercise-Induced Symptoms, and Endurance Performance in Ultra-Endurance Athletes
Official title: Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultra-endurance Athletes With Gastrointestinal Symptoms
Keywords: signs and symptoms, digestive
Probiotics
Oral rehydration therapy
Gastrointestinal Microbiome
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes of the gut microbiome after a 4-week supplementation period
timeFrame: Change from Baseline Gut Microbiome at 4 weeks
Secondary outcomes:
measure: Changes in blood markers of exercise-associated oxidative stress (8-isoprostaglandin 2Fa, Total Antioxidant Capacity, and Total Oxidant Capacity in plasma)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Centre of Athlete Training and Health Research
Study officials:
affiliation: Centre of Athlete Training and Health Research
name: Tuğba Kocahan, MD
role: STUDY_DIRECTOR
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