ProbioticsNCT05588674
The Effect of Probiotics on Exercise Performance and Recovery
A study testing Probiotic Supplement in people with Probiotics and Acute Exercise, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Probiotics, Acute Exercise
- What is being tested?
- Probiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jan 2023to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- Involved in regular or structured exercise/sport programmes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating a Novel Multi-strain Probiotic Supplement on Indices of Exercise Performance and Recovery
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.
Read the 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
At least 48 hours following visit 1, the participant will return to the exercise laboratory in the morning after a 10-hour overnight fast, where they will complete a familiarisation to the cycling time trial performance test. The time trial will consist of a short 10 min warm-up cycle at the power output equivalent to 95% GET followed by a partial time trial of fixed work at self-selected cycling speed and a full time trial of fixed work at self-selected cycling speed. The participant will also be shown a demonstration for the use of a faecal collection sampling device that will be used prior to the following visit, the device will be given to them to take away from the laboratory at used at home.
Visit 3
At least 72 hours hours following visit 2, the participant will be asked to attend the laboratory during the morning of the trial after after a 10-hour overnight fast. Participants will then complete visual analogue scales (VAS) to assess their appetite ratings. Appetite ratings will be assessed using 100 m VAS. They will then be provided with a standardised breakfast. The participant will also be asked to collect faecal samples at any convenient point in the 48 hours prior to the visit. The participant will then complete a questionnaire to assess their mood and anxiety profile as well as a food frequency questionnaire (FFQ). Other routine anthropometric information will be collected including height, body mass, blood pressure/pulse wave analysis, resting heart rate, body fat % and lean body mass, following a resting period. The participant will complete an exercise protocol that consists of a 45 min steady-state exercise at 95% GET intensity calculated from familiarisation trial. Following completion of the steady-state exercise, the participant will be asked to complete a cycling performance time trial in which they will be asked to complete a set amount of work as quickly as they are able. The work target is estimated using data obtained during familiarisation time trial. The set workload will be adjusted for female participants. Blood sampling will be collected prior to and following the steady-state exercise, and following completion of the time trial. Participants will then be randomised into a study group (probiotic or placebo). The participant will be asked to take the first dose prior to leaving the laboratory, with further doses of one capsule per day with breakfast.
Visit 4
During week 7 of supplementation, the participant will return to the laboratory to repeat the time trial completed as part of experimental trial 1 as a re-familiarisation exercise. Participants will then be familiarised with performing a counter movement jumps (CMJ). Thereafter, they will be familiarised with a hand-held pressure pain threshold (PPT) algometer.
Visit 5
Following 8 weeks from visit 3, the participants will return to the laboratory at after a 10-hour overnight fast. They will provide faecal samples (collected within 48 hours prior to the visit) and complete appetite, mood and anxiety questionnaires alongside a repeat FFQ. They will then repeat the same exercise performance testing protocol as done in Visit 3. Following the cessation of the performance trial 2, the participant will rest for at least 15 minutes or until their heart rate has returned to within 30 bpm of their pre-exercise level. They will then complete 100 drop jumps. Blood sampling will be collected prior to and following the steady-state exercise, following completion of the time trial, and at 1-hour after the completion of the drop jumps.
Visits 6, 7 and 8
The participant will be asked to return to the laboratory at 24, 48 and 72 hours post-Visit 5 after a 10-hour overnight fast and a resting blood sample will be collected. Subsequently, participants will perform 3 CMJs, 30 s apart with passive recovery. Then they will be asked to perform a squat and then rate their current delayed onset muscle soreness (DOMS) using a 200 mm (VAS) for generalised muscle pain. A hand-held PPT algometer will be used for the assessment of muscle-specific soreness at specific sites across the major muscles groups of the lower limbs. All sites will be marked to ensure that pressure is applied at the same spot for each repetition.
- Conditions
- Probiotics, Acute Exercise
- Being tested
- Probiotic Supplement, Placebo Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic SupplementDietary supplement
8.5 week supplementation period. One capsule daily.
Placebo CapsuleOther
8.5 week supplementation period. One capsule daily.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Probiotic Supplement |
| Placebo capsule | Placebo comparator | 418mg maltodextrin Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Performance
Pre- and post-supplementation levels of exercise performance tested via a cycle ergometer time trial
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4 days
Secondary outcomes (1)
Gut Microbial Diversity Testing by 16S Sequencing
Assessment of gut microbial diversity pre- and post-supplementation via faecal sampling
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start17 Jan 2023
- Primary completion17 May 2024
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Biopolis S.L.
- Responsible party
- Principal investigator, Liam Heaney, Loughborough University
- Investigators
- Liam M Heaney, PhD, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588674
- Sponsor's protocol ID
- LEON7551
- Status last verified
- Feb 2025
- First submitted
- 1 Oct 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Novel Multi-strain Probiotic Supplement on Indices of Exercise Performance and Recovery
- ClinicalTrials.gov ID
- NCT05588674
- Acronym / sponsor ID
- LEON7551
- Conditions
- Probiotics, Acute Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Biopolis S.L.
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
At least 48 hours following visit 1, the participant will return to the exercise laboratory in the morning after a 10-hour overnight fast, where they will complete a familiarisation to the cycling time trial performance test. The time trial will consist of a short 10 min warm-up cycle at the power output equivalent to 95% GET followed by a partial time trial of fixed work at self-selected cycling speed and a full time trial of fixed work at self-selected cycling speed. The participant will also be shown a demonstration for the use of a faecal collection sampling device that will be used prior to the following visit, the device will be given to them to take away from the laboratory at used at home.
Visit 3
At least 72 hours hours following visit 2, the participant will be asked to attend the laboratory during the morning of the trial after after a 10-hour overnight fast. Participants will then complete visual analogue scales (VAS) to assess their appetite ratings. Appetite ratings will be assessed using 100 m VAS. They will then be provided with a standardised breakfast. The participant will also be asked to collect faecal samples at any convenient point in the 48 hours prior to the visit. The participant will then complete a questionnaire to assess their mood and anxiety profile as well as a food frequency questionnaire (FFQ). Other routine anthropometric information will be collected including height, body mass, blood pressure/pulse wave analysis, resting heart rate, body fat % and lean body mass, following a resting period. The participant will complete an exercise protocol that consists of a 45 min steady-state exercise at 95% GET intensity calculated from familiarisation trial. Following completion of the steady-state exercise, the participant will be asked to complete a cycling performance time trial in which they will be asked to complete a set amount of work as quickly as they are able. The work target is estimated using data obtained during familiarisation time trial. The set workload will be adjusted for female participants. Blood sampling will be collected prior to and following the steady-state exercise, and following completion of the time trial. Participants will then be randomised into a study group (probiotic or placebo). The participant will be asked to take the first dose prior to leaving the laboratory, with further doses of one capsule per day with breakfast.
Visit 4
During week 7 of supplementation, the participant will return to the laboratory to repeat the time trial completed as part of experimental trial 1 as a re-familiarisation exercise. Participants will then be familiarised with performing a counter movement jumps (CMJ). Thereafter, they will be familiarised with a hand-held pressure pain threshold (PPT) algometer.
Visit 5
Following 8 weeks from visit 3, the participants will return to the laboratory at after a 10-hour overnight fast. They will provide faecal samples (collected within 48 hours prior to the visit) and complete appetite, mood and anxiety questionnaires alongside a repeat FFQ. They will then repeat the same exercise performance testing protocol as done in Visit 3. Following the cessation of the performance trial 2, the participant will rest for at least 15 minutes or until their heart rate has returned to within 30 bpm of their pre-exercise level. They will then complete 100 drop jumps. Blood sampling will be collected prior to and following the steady-state exercise, following completion of the time trial, and at 1-hour after the completion of the drop jumps.
Visits 6, 7 and 8
The participant will be asked to return to the laboratory at 24, 48 and 72 hours post-Visit 5 after a 10-hour overnight fast and a resting blood sample will be collected. Subsequently, participants will perform 3 CMJs, 30 s apart with passive recovery. Then they will be asked to perform a squat and then rate their current delayed onset muscle soreness (DOMS) using a 200 mm (VAS) for generalised muscle pain. A hand-held PPT algometer will be used for the assessment of muscle-specific soreness at specific sites across the major muscles groups of the lower limbs. All sites will be marked to ensure that pressure is applied at the same spot for each repetition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Supplement | Experimental | Dietary Supplement: Probiotic Supplement1 billion CFU per capsule of a multistrain probiotic formulation including one Bifidobacterium and two Lactobacilli strains with maltodextrin as a carrier |
| Placebo capsule | Placebo comparator | Other: Placebo Capsule418mg maltodextrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-40
- Involved in regular or structured exercise/sport programmes
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Supplement8.5 week supplementation period. One capsule daily. | Dietary supplement | Probiotic Supplement |
| Placebo Capsule8.5 week supplementation period. One capsule daily. | Other | Placebo capsule |
Primary outcome
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
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
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
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
1 secondary outcome
Gut Microbial Diversity Testing by 16S Sequencing
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Probiotics
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam M Heaney, PhD principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Supplement in people with Probiotics and Acute Exercise, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Performance (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.