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Clinical Trials/NCT05588674
NCT05588674CompletedNot Applicable

Investigating a Novel Multi-strain Probiotic Supplement on Indices of Exercise Performance and Recovery

Loughborough University1 site in 1 country36 target enrollmentStarted: January 17, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Recovery from Muscle Soreness

Study Overview

Brief Summary

This project will involve administering a multi-strain probiotic supplement to investigate the capacity to improve exercise performance and/or recovery. This will be done by assessing physiological measures (e.g. performance and muscle soreness), biochemical measures (e.g. oxidative stress and inflammation), and microbial diversity (i.e. associations with bacteria present in the gut). Participants will be well-trained, recreational exercisers and will visit the laboratory a total of eight times, including an 8-week probiotic vs placebo supplementation period.

Detailed Description

A total of 36 healthy, and active men and women aged 18-40 years of age will be recruited and allocated randomly into either a probiotic or placebo group, where both the investigator and participants will be blinded to the supplements (double-blind randomised control trial format).

Each participant will be asked to attend the research laboratory on eight separate occasions and to refrain from high-intensity exercise (e.g. long-distance running, competitive sport, weightlifting) in the 48 hours prior to each visit and light exercise (e.g. mild jogging or long walk) the day before each visit. They will also be asked to refrain from alcohol intake for 24 hours before each visit and caffeine intake on the morning of the visit.

Visit 1

Following consent, the participants will complete a ramp incremental exercise test for determination of volume of peak oxygen uptake (VO2peak) and the first abrupt change in the oxygen (VO2) and carbon dioxide (VCO2) concentrations of the expired air known as Gas Exchange Threshold (GET). The data collected during the incremental test will be used to calculate the work rates which will be employed during the subsequent exercise tests. The participant will also be asked to complete a food frequency and exercise questionnaire to understand general dietary and training practices.

Visit2

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age 18-40
  • •Involved in regular or structured exercise/sport programmes

Exclusion Criteria

  • •Current use or previous use within 3 months of probiotic supplements
  • •Current use or previous use within 3 months of antibiotics
  • •A recent history of surgery/injury associated with impairment of cycling performance
  • •History of chronic disease (excluding mild asthma)
  • •Poor tolerance to any component of the supplement
  • •Any blood-borne disorder/disease

Arms & Interventions

Placebo capsule

Placebo Comparator

418mg maltodextrin

Intervention: Placebo Capsule (Other)

Probiotic Supplement

Experimental

1 billion CFU per capsule of a multistrain probiotic formulation including one Bifidobacterium and two Lactobacilli strains with maltodextrin as a carrier

Intervention: Probiotic Supplement (Dietary Supplement)

Outcomes

Primary Outcomes

Recovery from Muscle Soreness

Time Frame: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of muscle soreness using VAS scales and handheld pain threshold algometer

Exercise Performance

Time Frame: 8 weeks

Pre- and post-supplementation levels of exercise performance tested via a cycle ergometer time trial

Functional Exercise Recovery

Time Frame: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of counter movement jump height

Biochemical Recovery from Exercise (Tissue Damage)

Time Frame: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of markers of muscle damage (CK, LDH) by immunoassay

Biochemical Recovery from Exercise (Oxidative Stress)

Time Frame: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of markers of oxidative stress (8-OHDG, MDA) by immunoassay

Biochemical Recovery from Exercise (Inflammation)

Time Frame: 4 days

Assessment of recovery from muscle damaging exercise through the measurement of pre- and post-damaging exercise testing of inflammatory markers (IL-6, CRP) by immunoassay

Secondary Outcomes

  • Gut Microbial Diversity Testing by 16S Sequencing(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Liam Heaney

Senior Lecturer/Principal Investigator

Loughborough University

Study Sites (1)

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