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

Sponsor

Liverpool John Moores University (Other)

Overall Status

Completed

CT.gov ID

NCT05615961

Collaborator

Georgia Southern University (Other), University of Illinois at Chicago (Other)

Enrollment

Location

Arms

3.3

Actual Duration (Months)

21.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gut Microbiome Gut Microbiota Aerobic Exercise Gastrointestinal Tract Irritation Athletes Probiotics	Dietary Supplement: Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK) Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are assigned into either supplement or placebo intervention groups, in a pair-matched, double-blind, placebo controlled manner.Participants are assigned into either supplement or placebo intervention groups, in a pair-matched, double-blind, placebo controlled manner.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The study has been blinded by an impartial third party from the company that has provided both the probiotic supplements and the placebo capsules.

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 1, 2022

Actual Primary Completion Date :

Oct 10, 2022

Actual Study Completion Date :

Oct 10, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liverpool John Moores University	Liverpool	Merseyside	United Kingdom	L3 3AF

Sponsors and Collaborators

Liverpool John Moores University
Georgia Southern University
University of Illinois at Chicago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liverpool John Moores University

ClinicalTrials.gov Identifier:

NCT05615961

Other Study ID Numbers:

021/SPS/051

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 14, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Liverpool John Moores University

Study Results

No Results Posted as of Nov 14, 2022