Exercise Induced Muscle DamageNCT07219498
Effects of a 5-Week Probiotic Supplementation Intervention on Markers of Delayed Onset Muscle Soreness
A study testing Lactobacillus casei in people with Exercise Induced Muscle Damage and Delayed Onset Muscle Soreness (DOMS), run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how probiotic supplementation (PS) influences post-exercise recovery in healthy, physically active young adults. Researchers aim to determine if the Lactobacillus casei probiotic strain reduces symptoms of delayed onset muscle soreness (DOMS) based on perceived muscle soreness… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Induced Muscle Damage, Delayed Onset Muscle Soreness (DOMS)
- What is being tested?
- Lactobacillus casei
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- complete a minimum of 150 minutes a week of at least moderate intensity exercise in either an endurance-based or resistance-based training style based on a self-reported physical activity over the past month
- good general health with no injuries or health conditions that would affect physical activity
- willing to abstain from consistent NSAID use and other probiotic supplements over the course of this study
Who cannot join
- known musculoskeletal injuries or physical limitations that could interfere with performing the designated physical activity required
- underlying conditions that could place them at an increased risk during exercise such as cardiovascular, respiratory, or metabolic diseases
- currently take a probiotic supplement, are prescribed and taking an antibiotic during the intervention, or report using NSAIDs or steroids within the recovery time window
- report using an NSAID more than twice a week on a regular basis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jakob Fischer, 507-236-8051, fisc0887@d.umn.edu
About this study
The purpose of this study is to evaluate how probiotic supplementation (PS) influences post-exercise recovery in healthy, physically active young adults. Researchers aim to determine if the Lactobacillus casei probiotic strain reduces symptoms of delayed onset muscle soreness (DOMS) based on perceived muscle soreness, pressure pain threshold, and power output following exercise induced muscle damage (EIMD).
- Being tested
- Lactobacillus casei, Placebo Capsule(s)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus caseiDietary supplement
Probiohealth is the manufacturer of this strain and they use a stringent quality control program that utilizes a multi point product variability check system.
Placebo Capsule(s)Other
The brand name of placebo capsules that will be used in this study is Magic Bullet Placebo Capsules. This placebo is manufactured by Progressive Placebo as stated on the product label.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Group | Active comparator | Not described Receives: Dietary Supplement: Lactobacillus casei |
| Placebo Group | Placebo comparator | Not described Receives: Other: Placebo Capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived muscle soreness
Visual Analog Scale for perceived muscle soreness Each number on the scale will be designated with a descriptive word that corresponds to the soreness level they are experiencing. The scale will be laid out in order of increasing muscle soreness with "1" representing no pain.
Measured: From baseline to post 5-week intervention
Change in pressure pain threshold (PPT)
Calf pressure pain threshold (PPT) will be assessed by placing marks on the medial condyle of the femur and the posterior of the medial malleolus. The researcher will place the algometer on the muscle belly exactly halfway between the two marks. Volunteers will be instructed to specify when the first onset of pain occurs as the researcher gradually applies pressure. Quadricep measurements will involve the participant lying in the supine position where marks will be made on the anterior inferior iliac spine and the top of the patella so the researchers can once again find a point exactly halfway between these two locations to apply the algometer. Participants will be instructed to verbally indicate to the researcher when the onset of pain occurs as pressure is applied.
Measured: From baseline to post 5-week intervention
Change in countermovement jump assessment (CMJ) performance recovery
The researchers will demonstrate and instruct volunteers to "Stand upright with their hands above their head. When you are ready, bend your knees and stick your hips back while keeping your hands to your hips. Jump as high as possible and land softly." Participants will perform three CMJs separated by 60 seconds. Jump height will be recorded in cm and the highest value will be recorded.
Measured: From baseline to post 5-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start5 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise Induced Muscle DamageStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Stenson, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219498
- Sponsor's protocol ID
- Probiotic Supplementation
- Status last verified
- Apr 2026
- First submitted
- 17 Oct 2025
- Last updated
- 4 May 2026
- 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 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 5-Week Probiotic Supplementation Intervention on Markers of Delayed Onset Muscle Soreness
- ClinicalTrials.gov ID
- NCT07219498
- Acronym / sponsor ID
- Probiotic Supplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 2025 (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.
The purpose of this study is to evaluate how probiotic supplementation (PS) influences post-exercise recovery in healthy, physically active young adults. Researchers aim to determine if the Lactobacillus casei probiotic strain reduces symptoms of delayed onset muscle soreness (DOMS) based on perceived muscle soreness, pressure pain threshold, and power output following exercise induced muscle damage (EIMD).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Active comparator | Dietary Supplement: Lactobacillus casei |
| Placebo Group | Placebo comparator | Other: Placebo Capsule(s) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- complete a minimum of 150 minutes a week of at least moderate intensity exercise in either an endurance-based or resistance-based training style based on a self-reported physical activity over the past month
- good general health with no injuries or health conditions that would affect physical activity
- willing to abstain from consistent NSAID use and other probiotic supplements over the course of this study
Key exclusion criteria (4 listed)
- known musculoskeletal injuries or physical limitations that could interfere with performing the designated physical activity required
- underlying conditions that could place them at an increased risk during exercise such as cardiovascular, respiratory, or metabolic diseases
- currently take a probiotic supplement, are prescribed and taking an antibiotic during the intervention, or report using NSAIDs or steroids within the recovery time window
- report using an NSAID more than twice a week on a regular basis
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 |
|---|---|---|
| Lactobacillus caseiProbiohealth is the manufacturer of this strain and they use a stringent quality control program that utilizes a multi point product variability check system. | Dietary supplement | Probiotic Group |
| Placebo Capsule(s)The brand name of placebo capsules that will be used in this study is Magic Bullet Placebo Capsules. This placebo is manufactured by Progressive Placebo as stated on the product label. | Other | Placebo Group |
Primary outcome
Change in perceived muscle soreness
Time frame: From baseline to post 5-week intervention
Visual Analog Scale for perceived muscle soreness Each number on the scale will be designated with a descriptive word that corresponds to the soreness level they are experiencing. The scale will be laid out in order of increasing muscle soreness with "1" representing no pain.
Change in pressure pain threshold (PPT)
Time frame: From baseline to post 5-week intervention
Calf pressure pain threshold (PPT) will be assessed by placing marks on the medial condyle of the femur and the posterior of the medial malleolus. The researcher will place the algometer on the muscle belly exactly halfway between the two marks. Volunteers will be instructed to specify when the first onset of pain occurs as the researcher gradually applies pressure. Quadricep measurements will involve the participant lying in the supine position where marks will be made on the anterior inferior iliac spine and the top of the patella so the researchers can once again find a point exactly halfway between these two locations to apply the algometer. Participants will be instructed to verbally indicate to the researcher when the onset of pain occurs as pressure is applied.
Change in countermovement jump assessment (CMJ) performance recovery
Time frame: From baseline to post 5-week intervention
The researchers will demonstrate and instruct volunteers to "Stand upright with their hands above their head. When you are ready, bend your knees and stick your hips back while keeping your hands to your hips. Jump as high as possible and land softly." Participants will perform three CMJs separated by 60 seconds. Jump height will be recorded in cm and the highest value will be recorded.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Mary Stenson principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei in people with Exercise Induced Muscle Damage and Delayed Onset Muscle Soreness (DOMS), run by University of Minnesota at 1 site in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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 States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakob Fischer (507-236-8051, fisc0887@d.umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived muscle soreness (time frame: From baseline to post 5-week intervention). The study lists 3 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 4 May 2026.