search
Back to results

Exercise, Gut Microbiota in Sedentary Adults With Overweight

Primary Purpose

Metabolic Disturbance

Status
Withdrawn
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
HIIT group
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Disturbance focused on measuring Gut microbiota, Hepatic function, Obesity, Exercise

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Robinson Ramírez-Vélez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HIIT group

SIT group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Gut microbiota
Change from Baseline in the gut microbiota composition measured by amplicon sequencing
Plasma metabolomic profile
Change from Baseline in the metabolomic profile will be also evaluated by a HPLC-MS approach

Secondary Outcome Measures

Plasma hepatokines
Change from Baseline in the Chemerin will be measured using ELISA kits
Plasma hepatokines
Change from Baseline in the Selenoprotein P will be measured using ELISA kits
Plasma hepatokines
Change from Baseline in the Fetuin-A will be measured using ELISA kits
Plasma hepatokines
Change from Baseline in the FGF21 (fibroblast growth factor 21) Leukocyte cell-derived will be measured using ELISA kits
Glucose
Change from Baseline will be also evaluated by a spectroscopy
Insulin
Change from Baseline will be also evaluated by a ELISA
Glycated hemoglobin
Change from Baseline will be also evaluated by a ELISA
Bioinflammatory blood markers
Change from Baseline measure of plasma IL-1 concentrations measured ELISA
Bioinflammatory blood markers
Change from Baseline measure of plasma IL6 concentrations measured ELISA
Bioinflammatory blood markers
Change from Baseline measure of plasma TNF-alfa concentrations measured ELISA
Bioinflammatory blood markers
Change from Baseline measure of plasma CRP concentrations measured ELISA
Body composition
Differences in body weight (kilograms) measured by DXA
Body composition
Differences in body fat (%) measured by DXA
Body composition
Differences in mass muscle measured by DXA
Physical fitness
Differences in Muscular strength (handgrip test) in kg
Physical fitness
Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min
Energy substrate oxidation
Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (K5 cosmed)
Resting Metabolic Rate
Resting metabolic rate was measured before and after the interventions (K5 Cosmed)

Full Information

First Posted
April 21, 2018
Last Updated
March 23, 2020
Sponsor
Universidad Santo Tomas
Collaborators
Universidad de Santiago de Chile, Universidad Pública de Navarra, Universidad del Rosario, NavarraBiomed Biomedical Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03515642
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely, prior to enrollment of first participant due to PI not employment at University.
Study Start Date
March 25, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Santo Tomas
Collaborators
Universidad de Santiago de Chile, Universidad Pública de Navarra, Universidad del Rosario, NavarraBiomed Biomedical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disturbance
Keywords
Gut microbiota, Hepatic function, Obesity, Exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT group
Arm Type
Experimental
Arm Description
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.
Arm Title
SIT group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
HIIT group
Other Intervention Name(s)
High/low volume exercise
Intervention Description
Physical Training
Primary Outcome Measure Information:
Title
Gut microbiota
Description
Change from Baseline in the gut microbiota composition measured by amplicon sequencing
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Plasma metabolomic profile
Description
Change from Baseline in the metabolomic profile will be also evaluated by a HPLC-MS approach
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Secondary Outcome Measure Information:
Title
Plasma hepatokines
Description
Change from Baseline in the Chemerin will be measured using ELISA kits
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Plasma hepatokines
Description
Change from Baseline in the Selenoprotein P will be measured using ELISA kits
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Plasma hepatokines
Description
Change from Baseline in the Fetuin-A will be measured using ELISA kits
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Plasma hepatokines
Description
Change from Baseline in the FGF21 (fibroblast growth factor 21) Leukocyte cell-derived will be measured using ELISA kits
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Glucose
Description
Change from Baseline will be also evaluated by a spectroscopy
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Insulin
Description
Change from Baseline will be also evaluated by a ELISA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Glycated hemoglobin
Description
Change from Baseline will be also evaluated by a ELISA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Bioinflammatory blood markers
Description
Change from Baseline measure of plasma IL-1 concentrations measured ELISA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Bioinflammatory blood markers
Description
Change from Baseline measure of plasma IL6 concentrations measured ELISA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Bioinflammatory blood markers
Description
Change from Baseline measure of plasma TNF-alfa concentrations measured ELISA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Bioinflammatory blood markers
Description
Change from Baseline measure of plasma CRP concentrations measured ELISA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Body composition
Description
Differences in body weight (kilograms) measured by DXA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Body composition
Description
Differences in body fat (%) measured by DXA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Body composition
Description
Differences in mass muscle measured by DXA
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Physical fitness
Description
Differences in Muscular strength (handgrip test) in kg
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Physical fitness
Description
Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Energy substrate oxidation
Description
Fat and carbohydrate oxidation in the fasted and postprandial state measured before and after the interventions using indirect calorimetry (K5 cosmed)
Time Frame
Baseline, and 6 weeks immediately after the interventions ends
Title
Resting Metabolic Rate
Description
Resting metabolic rate was measured before and after the interventions (K5 Cosmed)
Time Frame
Baseline, and 6 weeks immediately after the interventions ends

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Robinson Ramírez-Vélez
City
Bogotá
State/Province
Cundinamarca
ZIP/Postal Code
111221
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Exercise, Gut Microbiota in Sedentary Adults With Overweight

We'll reach out to this number within 24 hrs