Effect of an Exercise Bout in Plasma and Fecal Profile

NCT04244149 | Completed

• 1 other identifier: UEM0003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Plasma metabolome profile

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

  Changes from baseline to 30 min after the exercise intervention

• Fecal microbiota

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

  Changes from baseline to 30 min after the exercise intervention

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will exert an exercise prolonged session

Other: Prolonged Exercise session

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Maria del Mar Larrosa Pérez

Villaviciosa de Odón, Madrid, 28670, Spain

Location

Study Officials

• Mar Larrosa, PhD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure Professor

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 28, 2020
• Study Start: February 20, 2020
• Primary Completion: March 10, 2020
• Study Completion: March 13, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon publication
• Access Criteria: Data will be in a public repository

Locations

ES (1)