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

NCT05615961 | Completed

• 1 other identifier: 021/SPS/051
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Microbiome; Gut Microbiota; Aerobic Exercise; Gastrointestinal Tract Irritation; Athletes; Probiotics

Keywords

Probiotics; Endurance Exercise; Triathlon; GI Disturbance; Gut Microbiome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Training volume and intensity

  8-weeks

• Perceived stress

  8-weeks

• Quality of sleep

  8-weeks

Study Arms (2)

Probiotic Supplementation Arm

EXPERIMENTAL

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)

Placebo Arm

PLACEBO COMPARATOR

This group will receive the placebo capsules for 4-weeks prior to their ironman race performance.

Dietary Supplement: Placebo

Interventions

Probiotics (Lab4 probiotics, Cultech, Port Talbot, Wales, UK) DIETARY_SUPPLEMENT

The intervention is a unique blend of probiotic cultures from a well-established manufacturer.

Also known as: Lab4 Probiotics, Cultech, Port Talbot, Wales, UK

Probiotic Supplementation Arm

Placebo DIETARY_SUPPLEMENT

Placebo Tablets

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead
• Georgia Southern University: collaborator
• University of Illinois at Chicago: collaborator

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study has been blinded by an impartial third party from the company that has provided both the probiotic supplements and the placebo capsules.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 14, 2022
• Study Start: July 1, 2022
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)