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Exercise, Gut Microbiota in Sedentary Adults With Overweight

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ClinicalTrials.gov Identifier: NCT03515642
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Collaborators:
Universidad de Santiago de Chile
Universidad Pública de Navarra
Universidad del Rosario
NavarraBiomed Biomedical Research Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolic Disturbance Behavioral: HIIT group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Two Exercise Programme on Gut Microbiota, Hepatic Metabolism and Adipokines in Sedentary Adults With Overweight
Actual Study Start Date : March 25, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIIT group
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
Physical Training
Other Name: High/low volume exercise

Active Comparator: SIT group
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
Physical Training
Other Name: High/low volume exercise




Primary Outcome Measures :
  1. Gut microbiota [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline in the gut microbiota composition measured by amplicon sequencing

  2. Plasma metabolomic profile [ Time Frame: Baseline, 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 :
  1. Plasma hepatokines [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline in the Chemerin will be measured using ELISA kits

  2. Plasma hepatokines [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline in the Selenoprotein P will be measured using ELISA kits

  3. Plasma hepatokines [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline in the Fetuin-A will be measured using ELISA kits

  4. Plasma hepatokines [ Time Frame: Baseline, 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

  5. Glucose [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline will be also evaluated by a spectroscopy

  6. Insulin [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline will be also evaluated by a ELISA

  7. Glycated hemoglobin [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline will be also evaluated by a ELISA

  8. Bioinflammatory blood markers [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline measure of plasma IL-1 concentrations measured ELISA

  9. Bioinflammatory blood markers [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline measure of plasma IL6 concentrations measured ELISA

  10. Bioinflammatory blood markers [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline measure of plasma TNF-alfa concentrations measured ELISA

  11. Bioinflammatory blood markers [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Change from Baseline measure of plasma CRP concentrations measured ELISA

  12. Body composition [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Differences in body weight (kilograms) measured by DXA

  13. Body composition [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Differences in body fat (%) measured by DXA

  14. Body composition [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Differences in mass muscle measured by DXA

  15. Physical fitness [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Differences in Muscular strength (handgrip test) in kg

  16. Physical fitness [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Differences in Maximum Oxygen Consumption (VO2 max K5 Gas Analyser) in ml/kg/min

  17. Energy substrate oxidation [ Time Frame: Baseline, 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)

  18. Resting Metabolic Rate [ Time Frame: Baseline, and 6 weeks immediately after the interventions ends ]
    Resting metabolic rate was measured before and after the interventions (K5 Cosmed)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515642


Contacts
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Contact: Robinson Ramírez-Vélez, PhD +57 (1) 2970200 ext 3428 robin640@hotmail.com
Contact: Jorge E Correa-Bautista, PhD +57 (1) 2970200 ext 3428 jorge.correa@urosario.edu.co

Locations
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Colombia
Robinson Ramírez-Vélez Recruiting
Bogotá, Cundinamarca, Colombia, 111221
Contact: Robinson Ramírez-Vélez, Ph.D    +57 (1) 2970200    robin640@hotmail.com   
Contact: Jorge E Correa-Bautista, Ph.D    +57 (1) 2970200    jorge.correa@urosario.edu.co   
Sub-Investigator: Viviana Aya, MSc         
Sub-Investigator: Mikel Izquierdo, Ph.D         
Sub-Investigator: Juan D Ramírez, Ph.D         
Sub-Investigator: Miguel Barajas, Ph.D         
Sub-Investigator: Joaquín Fernández-Irigoyen, Ph.D         
Sub-Investigator: Enrique Santamaría, Ph.D         
Sub-Investigator: Jorge E Correa-Bautista, Ph.D         
Principal Investigator: Robinson Ramírez-Vélez, Ph.D         
Sponsors and Collaborators
Universidad Santo Tomas
Universidad de Santiago de Chile
Universidad Pública de Navarra
Universidad del Rosario
NavarraBiomed Biomedical Research Center

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Responsible Party: Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT03515642     History of Changes
Other Study ID Numbers: DVO005-1-338-CEI882
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad Santo Tomas:
Gut microbiota
Hepatic function
Obesity
Exercise
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms