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

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ClinicalTrials.gov Identifier: NCT04779281
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Asli Devrim Lanpir, Istanbul Medeniyet University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ultra-endurance Athletes With Gastrointestinal Symptoms Dietary Supplement: Oral Rehydration Salts supplemented with L. Rhamnosus GG Dietary Supplement: Oral Rehydration Salts only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Nutritional Status and Probiotics on Exercise-Related Clinical and Gastrointestinal Symptoms and Endurance Performance in Ultra-Endurance Athletes
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : May 15, 2019
Actual Study Completion Date : May 15, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral 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 Supplement: Oral Rehydration Salts only
A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose
Experimental: Oral Rehydration Salts only
A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose
 Dietary Supplement: Oral 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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04779281


Locations
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Turkey
Centre of Athlete Training and Health Research
Ankara, Turkey, 068290
Sponsors and Collaborators
Istanbul Medeniyet University
Investigators
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Study Director: Tuğba Kocahan, MD Centre of Athlete Training and Health Research
More Information
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Publications of Results:
Maughan RJ, Shirreffs SM. Sports Beverages for Optimizing Physical Performance. In: Wilson T., Temple N. (eds) Beverage Impacts on Health and Nutrition. Nutrition and Health. Humana Press, Cham. 2016.

Other Publications:

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Responsible Party: Asli Devrim Lanpir, Research Assistant, PhD, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT04779281    
Other Study ID Numbers: KA-180011
18-AKD-89 ( Other Identifier: Turkey Medicines and Medical Devices Agency )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asli Devrim Lanpir, Istanbul Medeniyet University:
signs and symptoms, digestive
Probiotics
Oral rehydration therapy
Gastrointestinal Microbiome