HealthyMEMEXNCT04244149
Effect of an Exercise Bout in Plasma and Fecal Profile
A study testing Prolonged Exercise session in people with Healthy, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
The aim of this project is to study the effect of a bout of exercise on the metabolomic profile of plasma and feces as well as its influence on the intestinal microbiota. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prolonged Exercise session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 20 Feb 2020to 13 Mar 2020
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 years of age
- high physical condition (VO2 ≥ 55 ml/kg/min)
- BMI 18-25 kg/m2
Who cannot join
- antibiotics intake during 3 months prior to the study,
- smoking
- nutritional complements
- ergogenic complements
- prebiotics
- probiotics
Show all 10Show fewer
- vegetarian or vegan diet
- chronic medication
- gastrointestinal surgery
- Any diagnosed disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Effect of Exhaustive Exercise From a Metabolomic and Metagenomic Approach
The aim of this project is to study the effect of a bout of exercise on the metabolomic profile of plasma and feces as well as its influence on the intestinal microbiota.
Read the detailed description
The practice of physical exercise has numerous health benefits, preventing the appearance and development of cardiovascular diseases and various types of cancer. Exercise causes changes in the vascular, muscular and pulmonary systems, etc. One of the benefits that can result from exercise modification of the intestinal microbiota and its metabolic profile. In order to identify the potential changes that exercise has on the intestinal microbiota and its metabolic profile, the purpose of this study is to identify changes in the plasma and fecal metabolome and in fecal microbiota associated with a bout of exercise
- Conditions
- Healthy
- Being tested
- Prolonged Exercise session
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged Exercise sessionOther
After a standardized warm-up of 10 minutes of continuous running on a treadmill at 60% of their maximum heart rate (HRmax), subjects will perform a maximum oxygen consumption test (VO2max) with a gas analyzer (UltimaTM Series, MGC Diagnostic Corporation, St. Paul, MN, USA. The protocol will start with a slope of 1% at a speed of 10 km/h, with increments of 0.3 km/h every 30 s until volitional exhaustion. Finally, ten minutes after the treadmill test, volunteers will run 1 kilometer (t1km) as fast as possible and the time needed to cover the distance will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will exert an exercise prolonged session Receives: Other: Prolonged Exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma metabolome profile
Abundance of blood metabolites, metabolic networks, and metabolic pathways activity
Measured: Changes from baseline to 30 min after the exercise intervention
Fecal microbiota
Abundance of gut microbial taxa, communities, and metabolic pathways activity
Measured: Changes from baseline to 30 min after the exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start20 Feb 2020
- Primary completion10 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mar Larrosa, Universidad Europea de Madrid
- Investigators
- Mar Larrosa, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244149
- Sponsor's protocol ID
- UEM0003
- Acronym
- MEMEX
- Status last verified
- Jun 2020
- First submitted
- 20 Jan 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication. Metagenomic raw data will be deposited in the http://www.ncbi.nlm.nih.gov/sra
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effect of Exhaustive Exercise From a Metabolomic and Metagenomic Approach
- ClinicalTrials.gov ID
- NCT04244149
- Acronym / sponsor ID
- MEMEX / UEM0003
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 28 Jan 2020 (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 project is to study the effect of a bout of exercise on the metabolomic profile of plasma and feces as well as its influence on the intestinal microbiota.
Detailed description
The practice of physical exercise has numerous health benefits, preventing the appearance and development of cardiovascular diseases and various types of cancer. Exercise causes changes in the vascular, muscular and pulmonary systems, etc. One of the benefits that can result from exercise modification of the intestinal microbiota and its metabolic profile. In order to identify the potential changes that exercise has on the intestinal microbiota and its metabolic profile, the purpose of this study is to identify changes in the plasma and fecal metabolome and in fecal microbiota associated with a bout of exercise
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Prolonged Exercise sessionParticipants will exert an exercise prolonged session |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years of age
- high physical condition (VO2 ≥ 55 ml/kg/min)
- BMI 18-25 kg/m2
Key exclusion criteria (10 listed)
- antibiotics intake during 3 months prior to the study,
- smoking
- nutritional complements
- ergogenic complements
- prebiotics
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 |
|---|---|---|
| Prolonged Exercise sessionAfter a standardized warm-up of 10 minutes of continuous running on a treadmill at 60% of their maximum heart rate (HRmax), subjects will perform a maximum oxygen consumption test (VO2max) with a gas analyzer (UltimaTM Series, MGC Diagnostic Corporation, St. Paul, MN, USA. The protocol will start with a slope of 1% at a speed of 10 km/h, with increments of 0.3 km/h every 30 s until volitional exhaustion. Finally, ten minutes after the treadmill test, volunteers will run 1 kilometer (t1km) as fast as possible and the time needed to cover the distance will be recorded. | Other | Intervention group |
Primary outcome
Plasma metabolome profile
Time frame: Changes from baseline to 30 min after the exercise intervention
Abundance of blood metabolites, metabolic networks, and metabolic pathways activity
Fecal microbiota
Time frame: Changes from baseline to 30 min after the exercise intervention
Abundance of gut microbial taxa, communities, and metabolic pathways activity
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 22 Jun 2020.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication. Metagenomic raw data will be deposited in the http://www.ncbi.nlm.nih.gov/sra
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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.
Mar Larrosa, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exercise session in people with Healthy, run by Universidad Europea de Madrid at 1 site in Spain.
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 10 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 22 Jun 2020. 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 Spain. 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. 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?
Plasma metabolome profile (time frame: Changes from baseline to 30 min after the exercise intervention). The study lists 2 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 22 Jun 2020.