Exercise, Gut Microbiota in Sedentary Adults With Overweight

Study Overview
=================
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.

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

Conditions
-----------------
Metabolic Disturbance

Intervention / Treatment
-----------------
* Behavioral: HIIT group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT group<br>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<br>* Physical Training<br>* Other names: High/low volume exercise;|
| Active Comparator: SIT group<br>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<br>* Physical Training<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gut microbiota, Hepatic function, Obesity, Exercise