Clinical Trials Directory

Trials / Completed

CompletedNCT05615961

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Liverpool John Moores University · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTProbiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK)The intervention is a unique blend of probiotic cultures from a well-established manufacturer.
DIETARY_SUPPLEMENTPlaceboPlacebo Tablets

Timeline

Start date
2022-07-01
Primary completion
2022-10-10
Completion
2022-10-10
First posted
2022-11-14
Last updated
2022-11-14

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05615961. Inclusion in this directory is not an endorsement.