Exercise, Gut Microbiota in Sedentary Adults With Overweight

Effect of Two Exercise Programme on Gut Microbiota, Hepatic Metabolism and Adipokines in Sedentary Adults With Overweight

This project offers the opportunity to obtain detailed measurements on the health of body composition, metabolic health, and intestinal microbial diversity in overweight adults; moreover to provide information about the effects of physical exercise on them. The aim of the research is to advance in the understanding of the mechanisms induced by physical exercise, which includes the measurement of nutritional parameters, clinical and biochemical biomarkers of hepatic/cardiometabolic health, as well as the application of differential proteomics technologies by means of Arrays of cytokines and intestinal microbiome, making this study a novel and pioneer in sensitive areas of primary health care in Latin America.

Study Overview

• Status: Withdrawn
• Conditions: Metabolic Disturbance
• Intervention / Treatment: Behavioral: HIIT group

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 111221
      • Robinson Ramírez-Vélez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy
• Sedentary males
• BMI>25 kg/m2, on a stable body weight for the last 3 months

Exclusion Criteria:

• Acute or chronic illness
• Use of antibiotics the past 2 months
• Smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIIT group; The HIIT modality consisted of 30-40 minutes (min) of steady-state, high-intensity training 3 d/wk on a stationary bicycle at the target heart rate (HR) range equivalent to 85% to 95% of the individual's maximum oxygen consumption rate (VO2max). Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6-weeks.	Behavioral: HIIT group; Physical Training; Other Names: High/low volume exercise
Active Comparator: SIT group; The SIT modality consisted of 6 to 10 repetitions of a 30 s segment of all-out exercise interspersed with 2 min of recovery, 3 d/wk on a stationary bicycle at the target heart rate (HR) range equivalent to 90% to 95% of the individual's maximum oxygen consumption rate (VO2max).	Behavioral: HIIT group; Physical Training; Other Names: High/low volume exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Change from Baseline in the gut microbiota composition measured by amplicon sequencing	Baseline, and 6 weeks immediately after the interventions ends
Plasma metabolomic profile	Change from Baseline in the metabolomic profile will be also evaluated by a HPLC-MS approach	Baseline, and 6 weeks immediately after the interventions ends

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma hepatokines	Change from Baseline in the Chemerin will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Plasma hepatokines	Change from Baseline in the Selenoprotein P will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Plasma hepatokines	Change from Baseline in the Fetuin-A will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Plasma hepatokines	Change from Baseline in the FGF21 (fibroblast growth factor 21) Leukocyte cell-derived will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Glucose	Change from Baseline will be also evaluated by a spectroscopy	Baseline, and 6 weeks immediately after the interventions ends
Insulin	Change from Baseline will be also evaluated by a ELISA	Baseline, and 6 weeks immediately after the interventions ends
Glycated hemoglobin	Change from Baseline will be also evaluated by a ELISA	Baseline, and 6 weeks immediately after the interventions ends
Bioinflammatory blood markers	Change from Baseline measure of plasma IL-1 concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Bioinflammatory blood markers	Change from Baseline measure of plasma IL6 concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Bioinflammatory blood markers	Change from Baseline measure of plasma TNF-alfa concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Bioinflammatory blood markers	Change from Baseline measure of plasma CRP concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Body composition	Differences in body weight (kilograms) measured by DXA	Baseline, and 6 weeks immediately after the interventions ends
Body composition	Differences in body fat (%) measured by DXA	Baseline, and 6 weeks immediately after the interventions ends
Body composition	Differences in mass muscle measured by DXA	Baseline, and 6 weeks immediately after the interventions ends
Physical fitness	Differences in Muscular strength (handgrip test) in kg	Baseline, and 6 weeks immediately after the interventions ends
Physical fitness	Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min	Baseline, and 6 weeks immediately after the interventions ends
Energy substrate oxidation	Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (K5 cosmed)	Baseline, and 6 weeks immediately after the interventions ends
Resting Metabolic Rate	Resting metabolic rate was measured before and after the interventions (K5 Cosmed)	Baseline, and 6 weeks immediately after the interventions ends

Collaborators and Investigators

• Sponsor: Universidad Santo Tomas
• Collaborators: Universidad Pública de Navarra; Universidad del Rosario; Universidad de Santiago de Chile; NavarraBiomed Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): August 30, 2019

Study Registration Dates

• First Submitted: April 21, 2018
• First Submitted That Met QC Criteria: May 2, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Gut microbiota; Hepatic function
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: DVO005-1-338-CEI882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No