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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04779281
Enrollment
24
Registered
2021-03-03
Start date
2018-09-01
Completion date
2019-05-15
Last updated
2021-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ultra-endurance Athletes With Gastrointestinal Symptoms

Keywords

signs and symptoms, digestive, Probiotics, Oral rehydration therapy, Gastrointestinal Microbiome

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.

Interventions

DIETARY_SUPPLEMENTOral Rehydration Salts supplemented with L. Rhamnosus GG

A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides

DIETARY_SUPPLEMENTOral Rehydration Salts only

A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
20 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes of the gut microbiome after a 4-week supplementation periodChange 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

MeasureTime frameDescription
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026