NCT05588674

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2024

Completed
Last Updated

September 9, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

October 1, 2022

Last Update Submit

September 2, 2025

Conditions

ProbioticsAcute Exercise

Outcome Measures

Primary Outcomes (6)

  • Exercise Performance

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

    8 weeks

  • Functional Exercise Recovery

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

    4 days

  • Recovery from Muscle Soreness

    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

    4 days

  • Biochemical Recovery from Exercise (Inflammation)

    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

    4 days

  • Biochemical Recovery from Exercise (Tissue Damage)

    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

    4 days

  • Biochemical Recovery from Exercise (Oxidative Stress)

    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

    4 days

Secondary Outcomes (1)

  • Gut Microbial Diversity Testing by 16S Sequencing

    8 weeks

Study Arms (2)

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

Dietary Supplement: Probiotic Supplement

Placebo capsule

PLACEBO COMPARATOR

418mg maltodextrin

Other: Placebo Capsule

Interventions

Probiotic SupplementDIETARY_SUPPLEMENT

8.5 week supplementation period. One capsule daily.

Probiotic Supplement
Placebo CapsuleOTHER

8.5 week supplementation period. One capsule daily.

Placebo capsule

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loughborough University

Loughborough, LE11 3TU, United Kingdom

Location

Study Officials

  • Liam M Heaney, PhD

    Loughborough University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer/Principal Investigator

Study Record Dates

First Submitted

October 1, 2022

First Posted

October 20, 2022

Study Start

January 17, 2023

Primary Completion

May 17, 2024

Study Completion

May 17, 2024

Last Updated

September 9, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)