NCT05389033

Brief Summary

Endurance athletes will be invited to participate in the following study. Subjects will visit the laboratory on three occasions, each time following an overnight fast. Briefly, following an initial assessment and familiarisation, participants will be required to complete an endurance bout of cycling exercise in hot environmental conditions before and after 4 weeks of supplementing with a probiotic or placebo. During the exercise bouts, breath samples will be collected for measurements of whole-body metabolism, blood samples will be collected to assess serum metabolites and markers of gastrointestinal (GI) damage, and subjective measures of effort and symptoms of GI thermal distress will be collected. Before and after each exercise bout, participants will be required to provide a faecal sample for analysis of the microbiome and GI inflammation

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 24, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

May 16, 2022

Last Update Submit

March 21, 2023

Conditions

Acute ExerciseProbiotics

Outcome Measures

Primary Outcomes (2)

  • Change in Gastro-Intestinal Disturbance Following Probiotic Supplementation

    Subjective assessment of GI discomfort experienced during cycling effort in the heat pre- and post- 4-week probiotic supplementation

    4 weeks

  • Change in Exogenous Glucose-Fructose Oxidation Following Probiotic Supplementation

    During exercise carbohydrate will be administered and the uptake and utilization of this will be measured via gas analysis of breath, tracer detection will be compared pre- and post- 4-week probiotic supplementation.

    4 weeks

Secondary Outcomes (6)

  • Change in time to exhaustion after 180 mins cycling exercise in the heat following probiotic supplementation

    4 weeks

  • Change in circulatory metabolites during exercise following probiotic supplementation

    4 weeks

  • Change in circulatory metabolites during exercise following probiotic supplementation

    4 weeks

  • Change in circulatory metabolites during exercise following probiotic supplementation

    4 weeks

  • Change in circulatory metabolites during exercise following probiotic supplementation

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Active probiotic

EXPERIMENTAL

Lactobacillus acidophilus (CUL60 and CUL21), Bifidobacterium bifidum (CUL20), Bifidobacterium animalis subs p. Lactis (CUL34), 25 billion CFU, (Proven Probiotics, United Kingdom)

Dietary Supplement: Probiotic bacteria

Placebo

PLACEBO COMPARATOR

Chicory Root Extract (Min 90% Fructo-oligosaccharides) - Providing: 100mg FOS Microcrystalline Cellulose - 137.26 mg

Other: Placebo Capsule

Interventions

Probiotic bacteriaDIETARY_SUPPLEMENT

28 days daily supplementation with active probiotic

Active probiotic
Placebo CapsuleOTHER

28 days daily supplementation with placebo

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Training/competing in exercise/sport for a minimum of 4 hours per week

You may not qualify if:

  • Free from current illness
  • No history of diabetes, high cholesterol, uncontrolled asthma or history of heart disease
  • Free from current musculoskeletal injury
  • No history of and free from GI related clinical conditions (IBS, Chron's Disease)
  • Not currently taking NSAIDs/Antihistamines/Immunosuppressive drugs
  • Without history of gastric ulcers or other gastric problems
  • Free from habitual use of NSAIDs i.e. 2 x per week for previous 1 month
  • Have no allergy or intolerance to standardised meal foods or be adherent to kosher diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University, Tom Reilly Building, Byrom Street Campus

Liverpool, Merseyside, L3 3AF, United Kingdom

RECRUITING

Study Officials

  • Jamie N Pugh, PhD

    Liverpool John Moores University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda F Williams

CONTACT

01519046467a.f.williams@ljmu.ac.uk

Dave Harris, PhD

CONTACT

01519046236d.harriss@ljmu.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 24, 2022

Study Start

July 15, 2021

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

GB(1)