Exercise, Gut Microbiota in Sedentary Adults With Overweight

Not Applicable

Withdrawn

• Conditions: Metabolic Disturbance

• Registration Number: NCT03515642
• Lead Sponsor: Universidad Santo Tomas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-25
• Study First Submitted: 2018-04-21
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-03
• Primary Completion: 2019-06-01
• Study Completion: 2019-08-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma hepatokines	Baseline, and 6 weeks immediately after the interventions ends	Change from Baseline in the FGF21 (fibroblast growth factor 21) Leukocyte cell-derived will be measured using ELISA kits
Body composition	Baseline, and 6 weeks immediately after the interventions ends	Differences in mass muscle measured by DXA
Glucose	Baseline, and 6 weeks immediately after the interventions ends	Change from Baseline will be also evaluated by a spectroscopy
Insulin	Baseline, and 6 weeks immediately after the interventions ends	Change from Baseline will be also evaluated by a ELISA
Physical fitness	Baseline, and 6 weeks immediately after the interventions ends	Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min
Glycated hemoglobin	Baseline, and 6 weeks immediately after the interventions ends	Change from Baseline will be also evaluated by a ELISA
Bioinflammatory blood markers	Baseline, and 6 weeks immediately after the interventions ends	Change from Baseline measure of plasma CRP concentrations measured ELISA
Energy substrate oxidation	Baseline, and 6 weeks immediately after the interventions ends	Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (K5 cosmed)
Resting Metabolic Rate	Baseline, and 6 weeks immediately after the interventions ends	Resting metabolic rate was measured before and after the interventions (K5 Cosmed)

Trial Locations

Locations (1)

Robinson Ramírez-Vélez; 🇨🇴 Bogotá, Cundinamarca, Colombia