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Completed

NCT Number: NCT04244149

Effect of an Exercise Bout in Plasma and Fecal Profile

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maria del Mar Larrosa Pérez

Villaviciosa de Odón, Madrid, 28670, Spain

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Prolonged Exercise session

Other

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.

Primary outcomes

  1. 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

  2. Fecal microbiota

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

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

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Exploring the Effect of Exhaustive Exercise From a Metabolomic and Metagenomic Approach

Acronym: MEMEX

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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