MicrotiaNCT04946578
The Effect of Prebiotics on Endurance Performance
A study testing Prebiotic in people with Microtia, run by Maastricht University at 1 site in Netherlands.
Trial summary
The aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Microtia
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Aug 2020to 30 Sep 2021
- 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 18 - 40 y
- BMI range 18.5 - 25 kg/m2
- Recreational active (performing non-competitive physical endurance exercise at least two times per week with a minimum duration of 60 minutes per exercise bout)
Who cannot join
- Smoking
- Performing regular resistance training (3+ times per week, carrying out progressive overload training)
- Subject following an overly imbalanced or restrictive diet as per nutritional advice
- Participants who received antibiotics in the 90 days prior to the start of the study
- Self-admitted lactose intolerance
- Administration of probiotic or prebiotic supplements in the 14 days prior to the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, Limburg
About this study
Official title: Modulation of the Intestinal Microbiome, and Its Effects on Endurance Exercise Capacity in Moderately Trained Individuals
The aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults.
Read the detailed description
The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.
a prebiotic supplement will be selected based on a participants gut microbiota. 1 sachet of prebiotic or placebo will be given twice a day over a period of 6 weeks.
Before the start of the study, a VO2max test will be performed. Subjects will bring faecal samples which is collected at home. A time to exhaustion of approximately 80% of their VO2max will be performed at baseline and after the 6 weeks intervention period.
- Conditions
- Microtia
- Being tested
- Prebiotic, Placebo
- Medical subject headings
- Congenital Microtia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
6 weeks of prebiotic supplementation twice a day
PlaceboOther
6 weeks of maltodextrin supplementation twice a day
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic intervention group | Experimental | Prebiotic supplementation Receives: Dietary Supplement: Prebiotic |
| Placebo control group | Placebo comparator | Maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Exhaustion
Time on cycle ergometer until exhaustion
Measured: From baseline to end of the study (up to max 45 days)
Secondary outcomes (5)
Gut microbiota composition
Composition of the gut microbiota by faecal sample analysis
Measured: From baseline to end of the study (up to max 45 days)
Plasma short chain fatty acids
Short chain fatty acids in plasma
Measured: From baseline to end of the study (up to max 45 days)
Blood glucose
Fasted blood glucose
Measured: From baseline to end of the study (up to max 45 days)
Insulin
Fasted insulin
Measured: From baseline to end of the study (up to max 45 days)
Intestinal permeability by sugar test
Intestinal permeability measured by a sugar drink test
Measured: From baseline to end of the study (up to max 45 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start24 Aug 2020
- Primary completion23 Aug 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrotiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred Troost, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946578
- Sponsor's protocol ID
- Sport and microbiota
- Status last verified
- Jun 2021
- First submitted
- 5 May 2021
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Intestinal Microbiome, and Its Effects on Endurance Exercise Capacity in Moderately Trained Individuals
- ClinicalTrials.gov ID
- NCT04946578
- Acronym / sponsor ID
- Sport and microbiota
- Conditions
- Microtia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 23 Aug 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 1 Jul 2021 (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 aim of this study is to investigate the effect of a six-week period personalised food intervention with prebiotic supplementation on intense exercise performance in healthy, recreationally active adults.
Detailed description
The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.
a prebiotic supplement will be selected based on a participants gut microbiota. 1 sachet of prebiotic or placebo will be given twice a day over a period of 6 weeks.
Before the start of the study, a VO2max test will be performed. Subjects will bring faecal samples which is collected at home. A time to exhaustion of approximately 80% of their VO2max will be performed at baseline and after the 6 weeks intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study conforms to a randomized, single-blinded, placebo-controlled parallel study design.
| Arm | Type | Receives |
|---|---|---|
| Prebiotic intervention group | Experimental | Dietary Supplement: PrebioticPrebiotic supplementation |
| Placebo control group | Placebo comparator | Other: PlaceboMaltodextrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female 18 - 40 y
- BMI range 18.5 - 25 kg/m2
- Recreational active (performing non-competitive physical endurance exercise at least two times per week with a minimum duration of 60 minutes per exercise bout)
Key exclusion criteria (6 listed)
- Smoking
- Performing regular resistance training (3+ times per week, carrying out progressive overload training)
- Subject following an overly imbalanced or restrictive diet as per nutritional advice
- Participants who received antibiotics in the 90 days prior to the start of the study
- Self-admitted lactose intolerance
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 |
|---|---|---|
| Prebiotic6 weeks of prebiotic supplementation twice a day | Dietary supplement | Prebiotic intervention group |
| Placebo6 weeks of maltodextrin supplementation twice a day | Other | Placebo control group |
Primary outcome
Time to Exhaustion
Time frame: From baseline to end of the study (up to max 45 days)
Time on cycle ergometer until exhaustion
5 secondary outcomes
Gut microbiota composition
Time frame: From baseline to end of the study (up to max 45 days)
Plasma short chain fatty acids
Time frame: From baseline to end of the study (up to max 45 days)
Blood glucose
Time frame: From baseline to end of the study (up to max 45 days)
Insulin
Time frame: From baseline to end of the study (up to max 45 days)
Intestinal permeability by sugar test
Time frame: From baseline to end of the study (up to max 45 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Microtia, run by Maastricht University at 1 site in Netherlands.
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 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: status not confirmed, as of the sponsor's last update on 1 Jul 2021. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Freddy Troost, Dr. (+31(0)43 3884296, f.troost@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Exhaustion (time frame: From baseline to end of the study (up to max 45 days)). 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 1 Jul 2021.