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Clinical Trials/NCT05615961
NCT05615961
Completed
Not Applicable

Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race

Liverpool John Moores University1 site in 1 country70 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gut Microbiome
Sponsor
Liverpool John Moores University
Enrollment
70
Locations
1
Primary Endpoint
Gastrointestinal symptoms during training and competition
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete.

Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event.

Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition.

Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84).

The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.

Detailed Description

The study will recruit ironman triathletes who have qualified for the Kona ironman World-championships in Hawaii. Participants will be allocated into either probiotic (Lab4 Probiotics, Cultech, Port Talbot, Wales, UK) or placebo (Maltodextrin) groups, in a double-blind fashion (Blinded by supplement supplier). Those recruited into the study will have their training load and gut symptoms monitored for 8-weeks prior to competition via the completion of online questionnaires (previously validated). Four-weeks prior to competition participants will provide a stool sample for microbiome analysis, they will then proceed to supplement with probiotic or placebo for 4-weeks. 24-h prior to competition they will provide a stool sample as well as providing a sample from the first bowel movement post-race, which will be used for microbiome analysis. Data will be collected for pre-race and raceday nutrition, as well as outcome measures for raceday performance and gastroitestinal symptoms experienced, again via online questionnaire. Stool samples will be analysed by an independent laboratory that specialises in microbiome analysis. Primary outcome measures will be the composition of the gut bacteria and the metabolites (substances produced) of the gut bacteria at baseline, pre-race and post-race. As well as the occurrence (frequency, duration, severity) of gastrointestinal symptoms during training and competition.

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
October 10, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged 18-85
  • Qualification for the Kona Ironman World-championships in Hawaii

Exclusion Criteria

  • Have a current musculoskeletal injury.
  • Currently unwell with cold or flu
  • Have been told they have liver disease
  • Have gastric Ulcer or other gastric/stomach problems
  • Have a condition/disease of the Gut/bowel.
  • Have diagnosed uncontrolled asthma
  • Have kidney problems
  • Have a chronic connective tissue disorder
  • Have suffered cerebrovascular disease such as a stroke
  • Are taking balcofen, methotrexate, tacrolimus and voriconazole, beta-blockers or diuretics drugs

Outcomes

Primary Outcomes

Gastrointestinal symptoms during training and competition

Time Frame: 8-weeks

This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire

Composition of the gut microbiome

Time Frame: 4-weeks

This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing

Secondary Outcomes

  • Training volume and intensity(8-weeks)
  • Perceived stress(8-weeks)
  • Quality of sleep(8-weeks)

Study Sites (1)

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