ClinicalTrials.gg
CompletedNCT04244149MEMEXUpdated Jun 22, 2020

Effect of an Exercise Bout in Plasma and Fecal Profile

An interventional study of Prolonged Exercise session in Healthy, sponsored by Universidad Europea de Madrid. Completed at 1 site in Spain. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-22.

Sponsored by Universidad Europea de Madrid · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study 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 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Universidad Europea de Madrid is the lead sponsor of 99 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-45 years of age
  • high physical condition (VO2 ≥ 55 ml/kg/min)
  • BMI 18-25 kg/m2

Exclusion criteria

Exclusion Criteria:

  • antibiotics intake during 3 months prior to the study,
  • smoking
  • nutritional complements
  • ergogenic complements
  • prebiotics
  • probiotics
  • vegetarian or vegan diet
  • chronic medication
  • gastrointestinal surgery
  • Any diagnosed disease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Intervention group

    Participants will exert an exercise prolonged session

    Other: Prolonged Exercise session

Interventions

  • OtherProlonged Exercise session

    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.

06

What researchers measure

Primary outcomes

  1. Plasma metabolome profile

    Abundance of blood metabolites, metabolic networks, and metabolic pathways activity

    Time frame: Changes from baseline to 30 min after the exercise intervention

  2. Fecal microbiota

    Abundance of gut microbial taxa, communities, and metabolic pathways activity

    Time frame: Changes from baseline to 30 min after the exercise intervention

07

Study locations

1 site
  • Maria del Mar Larrosa Pérez
    Villaviciosa de Odón, Madrid 28670, Spain
08

References and documents

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication. Metagenomic raw data will be deposited in the http://www.ncbi.nlm.nih.gov/sra

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Upon publication

Access criteria: Data will be in a public repository

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2020 to primary completion in Mar 2020, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2020
First posted
Jan 28, 2020
StartActual
Feb 20, 2020
Primary completionActual
Mar 10, 2020
CompletionActual
Mar 13, 2020
Last update
Jun 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04244149
Lead sponsor
Universidad Europea de Madrid
Responsible party
Mar Larrosa (Tenure Professor, Universidad Europea de Madrid) — Principal investigator
First posted
Jan 28, 2020
Start date
Feb 20, 2020
Primary completion
Mar 10, 2020
Completion
Mar 13, 2020
Last update
Jun 22, 2020

Study contacts

Mar Larrosa, PhD
principal investigator · Universidad Europea de Madrid

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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