Physical PerformanceNCT03259997
Efficacy of Probiotics on Physical Performance
A study testing Probiotic supplement in people with Physical Performance, run by Probi AB at 1 site in Sweden.
Trial summary
Efficacy of probiotics on physical performance Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance
- What is being tested?
- Probiotic supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteSweden
- Study dates
- 14 Aug 2017to 9 May 2018
- 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
- Male or female, aged 18 to 40 years, at the time of signing the informed consent form
- Provides signed and dated informed consent form
- Engaged in competitive sports and regularly training
- Non-anemic, iron-deficient
- Willing to comply with all study procedures and be available for the duration of the study
Who cannot join
- Use of probiotics
- Use of iron supplementation
- Use of ascorbic acid (Vitamin C) supplementation
- Hypersensitivity to any of the ingredients in the investigational product (IP)
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy of probiotics on physical performance
- Conditions
- Physical Performance
- Being tested
- Probiotic supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic supplementDietary supplement
Probiotic supplement
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplement | Active comparator | Not described Receives: Dietary Supplement: Probiotic supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic response at standardized workloads during ergometer cycling
Change from baseline in metabolic response at standardized workloads during ergometer cycling after 4,8 and 12 weeks of supplementation
Measured: 4,8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start14 Aug 2017
- Primary completion9 May 2018
- Study completion9 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Svensson, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259997
- Sponsor's protocol ID
- ProFormance135
- Status last verified
- Mar 2019
- First submitted
- 17 Aug 2017
- Last updated
- 20 Mar 2019
- 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 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Probiotics on Physical Performance
- ClinicalTrials.gov ID
- NCT03259997
- Acronym / sponsor ID
- ProFormance135
- Conditions
- Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 9 May 2018 (actual)
- First posted
- 24 Aug 2017 (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.
Efficacy of probiotics on physical performance
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 supplement | Active comparator | Dietary Supplement: Probiotic supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, aged 18 to 40 years, at the time of signing the informed consent form
- Provides signed and dated informed consent form
- Engaged in competitive sports and regularly training
- Non-anemic, iron-deficient
- Willing to comply with all study procedures and be available for the duration of the study
Key exclusion criteria (4 listed)
- Use of probiotics
- Use of iron supplementation
- Use of ascorbic acid (Vitamin C) supplementation
- Hypersensitivity to any of the ingredients in the investigational product (IP)
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 supplementProbiotic supplement | Dietary supplement | Probiotic supplement |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Metabolic response at standardized workloads during ergometer cycling
Time frame: 4,8 and 12 weeks
Change from baseline in metabolic response at standardized workloads during ergometer cycling after 4,8 and 12 weeks of supplementation
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 20 Mar 2019.
- 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. This study is not recruiting at the moment.
Michael Svensson, PhD principal investigator
Umeå 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 Physical Performance, run by Probi AB at 1 site in Sweden.
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 5 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: finished, as of the sponsor's last update on 20 Mar 2019. 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 Sweden. 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?
Metabolic response at standardized workloads during ergometer cycling (time frame: 4,8 and 12 weeks). 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 20 Mar 2019.