Exercise, Gut Microbiota in Sedentary Adults With Overweight

Metabolic Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03515642
• Other study ID #: DVO005-1-338-CEI882
• Status: Withdrawn
• Phase: N/A
• Start date: March 25, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2020
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 30, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Disturbance
• Overweight

Intervention

Behavioral:
• HIIT group
Physical Training

Locations

Country	Name	City	State
Colombia	Robinson Ramírez-Vélez	Bogotá	Cundinamarca

Sponsors (5)

Lead Sponsor	Collaborator
Universidad Santo Tomas	NavarraBiomed Biomedical Research Center, Universidad de Santiago de Chile, Universidad del Rosario, Universidad Pública de Navarra

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota	Change from Baseline in the gut microbiota composition measured by amplicon sequencing	Baseline, and 6 weeks immediately after the interventions ends
Primary	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	Plasma hepatokines	Change from Baseline in the Chemerin will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Plasma hepatokines	Change from Baseline in the Selenoprotein P will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Plasma hepatokines	Change from Baseline in the Fetuin-A will be measured using ELISA kits	Baseline, and 6 weeks immediately after the interventions ends
Secondary	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
Secondary	Glucose	Change from Baseline will be also evaluated by a spectroscopy	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Insulin	Change from Baseline will be also evaluated by a ELISA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Glycated hemoglobin	Change from Baseline will be also evaluated by a ELISA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Bioinflammatory blood markers	Change from Baseline measure of plasma IL-1 concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Bioinflammatory blood markers	Change from Baseline measure of plasma IL6 concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Bioinflammatory blood markers	Change from Baseline measure of plasma TNF-alfa concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Bioinflammatory blood markers	Change from Baseline measure of plasma CRP concentrations measured ELISA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Body composition	Differences in body weight (kilograms) measured by DXA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Body composition	Differences in body fat (%) measured by DXA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Body composition	Differences in mass muscle measured by DXA	Baseline, and 6 weeks immediately after the interventions ends
Secondary	Physical fitness	Differences in Muscular strength (handgrip test) in kg	Baseline, and 6 weeks immediately after the interventions ends
Secondary	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
Secondary	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
Secondary	Resting Metabolic Rate	Resting metabolic rate was measured before and after the interventions (K5 Cosmed)	Baseline, and 6 weeks immediately after the interventions ends