MedPath

Exercise, Gut Microbiota in Sedentary Adults With Overweight

Not Applicable
Withdrawn
Conditions
Metabolic Disturbance
Interventions
Behavioral: HIIT group
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

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WITHDRAWN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
Arm && Interventions
GroupInterventionDescription
HIIT groupHIIT groupThe 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.
SIT groupHIIT groupThe 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).
Primary Outcome Measures
NameTimeMethod
Gut microbiotaBaseline, and 6 weeks immediately after the interventions ends

Change from Baseline in the gut microbiota composition measured by amplicon sequencing

Plasma metabolomic profileBaseline, 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
NameTimeMethod
GlucoseBaseline, and 6 weeks immediately after the interventions ends

Change from Baseline will be also evaluated by a spectroscopy

InsulinBaseline, and 6 weeks immediately after the interventions ends

Change from Baseline will be also evaluated by a ELISA

Plasma hepatokinesBaseline, 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 compositionBaseline, and 6 weeks immediately after the interventions ends

Differences in mass muscle measured by DXA

Physical fitnessBaseline, and 6 weeks immediately after the interventions ends

Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min

Glycated hemoglobinBaseline, and 6 weeks immediately after the interventions ends

Change from Baseline will be also evaluated by a ELISA

Bioinflammatory blood markersBaseline, and 6 weeks immediately after the interventions ends

Change from Baseline measure of plasma CRP concentrations measured ELISA

Energy substrate oxidationBaseline, 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 RateBaseline, 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

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