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Completed

NCT Number: NCT04779281

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

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.

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Key information

Conditions

Ultra-endurance Athletes With Gastrointestinal Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Athlete Training and Health Research

Ankara, 068290, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral Rehydration Salts supplemented with L. Rhamnosus GG

Dietary Supplement

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

Oral Rehydration Salts only

Dietary Supplement

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

Primary outcomes

  1. Changes of the gut microbiome after a 4-week supplementation period

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2021
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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