Clinical trial NCT03515642: Exercise, Gut Microbiota in Sedentary Adults With Overweight
Official title: Effect of Two Exercise Programme on Gut Microbiota, Hepatic Metabolism and Adipokines in Sedentary Adults With Overweight
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metabolic Disturbance
Keywords: Gut microbiota
Hepatic function
Obesity
Exercise
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
Collaborators: name: Universidad de Santiago de Chile
name: Universidad Pública de Navarra
name: Universidad del Rosario
name: NavarraBiomed Biomedical Research Center
First posted: 2018-05-03
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gut microbiota
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Plasma metabolomic profile
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
Secondary outcomes:
measure: Plasma hepatokines
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Plasma hepatokines
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Plasma hepatokines
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Plasma hepatokines
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Glucose
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Insulin
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Glycated hemoglobin
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Bioinflammatory blood markers
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Bioinflammatory blood markers
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Bioinflammatory blood markers
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Bioinflammatory blood markers
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Body composition
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Body composition
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Body composition
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Physical fitness
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Physical fitness
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Energy substrate oxidation
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
measure: Resting Metabolic Rate
timeFrame: Baseline, and 6 weeks immediately after the interventions ends
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Robinson Ramírez-Vélez
state: Cundinamarca
Study officials:
References: