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

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.

Study Overview

• Status: Completed
• Conditions: Probiotics; Athletes; Gut Microbiota; Aerobic Exercise; Gut Microbiome; Gastrointestinal Tract Irritation
• Intervention / Treatment: Dietary supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK); Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L3 3AF
      • Liverpool John Moores University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Supplementation Arm; This group will receive the probiotic supplement for 4-weeks prior to their ironman race performance.	Dietary supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK); The intervention is a unique blend of probiotic cultures from a well-established manufacturer.; Other Names: Lab4 Probiotics, Cultech, Port Talbot, Wales, UK
Placebo Comparator: Placebo Arm; This group will receive the placebo capsules for 4-weeks prior to their ironman race performance.	Dietary supplement: Placebo; Placebo Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of the gut microbiome	This will assess the bacterial content in the gut of the participants, performed using shotgun metagenomic sequencing	4-weeks
Gastrointestinal symptoms during training and competition	This will be the subjective assessment of any gastrointestinal symptoms experienced during training and competition, from a previously validated questionnaire	8-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training volume and intensity	This will be a quantification of the amount of training completed in the 8 weeks leading up to the race, via questionnaire.	8-weeks
Perceived stress	This will be the subjective assessment of how stressed participants are in the 8 weeks leading up to competition, via questionnaire.	8-weeks
Quality of sleep	This will be a subjective assessment of how well-rested the participants are in the 8 weeks leading up to competition, via questionnaire.	8-weeks

Collaborators and Investigators

• Sponsor: Liverpool John Moores University
• Collaborators: University of Illinois at Chicago; Georgia Southern University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Endurance Exercise; Gut Microbiome; Triathlon; GI Disturbance
• Other Study ID Numbers: 021/SPS/051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No