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Probiotics and Exercise in the Heat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05389033
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
Liverpool John Moores University

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

Condition or disease Intervention/treatment Phase
Acute Exercise Probiotics Dietary Supplement: Probiotic bacteria Other: Placebo Capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Probiotics on Exercise Metabolism During Exercise in the Heat and Subsequent Effect on Gastrointestinal Microbiome
Actual Study Start Date : July 15, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active probiotic
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
28 days daily supplementation with active probiotic

Placebo Comparator: Placebo

Chicory Root Extract (Min 90% Fructo-oligosaccharides) - Providing:

100mg FOS Microcrystalline Cellulose - 137.26 mg

Other: Placebo Capsule
28 days daily supplementation with placebo




Primary Outcome Measures :
  1. Change in Gastro-Intestinal Disturbance Following Probiotic Supplementation [ Time Frame: 4 weeks ]
    Subjective assessment of GI discomfort experienced during cycling effort in the heat pre- and post- 4-week probiotic supplementation

  2. Change in Exogenous Glucose-Fructose Oxidation Following Probiotic Supplementation [ Time Frame: 4 weeks ]
    During exercise carbohydrate will be administered and the uptake and utilization of this will be measured via gas analysis of breath and tracer detection and will be compared pre- and post- 4-week probiotic supplementation.


Secondary Outcome Measures :
  1. Change in time to exhaustion after 180 mins cycling exercise in the heat following probiotic supplementation [ Time Frame: 4 weeks ]
    Participants will cycle at a wattage on the bike that is high enough to induce fatigue, they will cycle at this wattage until failure (inability to keep the pedals turning/voluntary stoppage). This will be compared pre- and post- 4-week probiotic supplementation.

  2. Change in circulatory metabolites during exercise following probiotic supplementation [ Time Frame: 4 weeks ]
    Glucose, lactate, insulin, non-esterified fatty acids, glycerol will be measured during exercise, this will be compared pre- and post- 4-week probiotic supplementation.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05389033


Contacts
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Contact: Amanda F Williams 01519046467 a.f.williams@ljmu.ac.uk
Contact: Dave Harris, PhD 01519046236 d.harriss@ljmu.ac.uk

Locations
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United Kingdom
Liverpool John Moores University, Tom Reilly Building, Byrom Street Campus Recruiting
Liverpool, Merseyside, United Kingdom, L3 3AF
Contact: Amanda F Williams    01519046467    a.f.williams@ljmu.ac.uk   
Contact: Dave Harriss, PhD    01519046236    d.harriss@ljmu.ac.uk   
Sponsors and Collaborators
Liverpool John Moores University
Investigators
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Principal Investigator: Jamie N Pugh, PhD Liverpool John Moores University
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Responsible Party: Liverpool John Moores University
ClinicalTrials.gov Identifier: NCT05389033    
Other Study ID Numbers: Pro Heat LJMU
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No