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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03515642
Date of registration: 21/04/2018
Prospective Registration: No
Primary sponsor: Universidad Santo Tomas
Public title: Exercise, Gut Microbiota in Sedentary Adults With Overweight
Scientific title: Effect of Two Exercise Programme on Gut Microbiota, Hepatic Metabolism and Adipokines in Sedentary Adults With Overweight
Date of first enrolment: March 25, 2018
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT03515642
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Colombia
Contacts
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Male
Health Condition(s) or Problem(s) studied
Metabolic Disturbance
Intervention(s)
Behavioral: HIIT group
Primary Outcome(s)
Plasma metabolomic profile [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Gut microbiota [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Secondary Outcome(s)
Resting Metabolic Rate [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Energy substrate oxidation [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Bioinflammatory blood markers [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Body composition [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Glucose [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Glycated hemoglobin [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Physical fitness [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Insulin [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Plasma hepatokines [Time Frame: Baseline, and 6 weeks immediately after the interventions ends]
Secondary ID(s)
DVO005-1-338-CEI882
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
NavarraBiomed Biomedical Research Center
Universidad de Santiago de Chile
Universidad Pública de Navarra
Universidad del Rosario
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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