Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver: Identification of Biomarkers and Development of Personalized Therapy: The MicroKid Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Hepatic fat
Study Overview
Brief Summary
The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)
Detailed Description
The MicroKid project will acts first as a case-control study (Study I) in order to identify the hepatic steatosis and intestinal and salivary microbiota in children grouped as non-overweight, obese-non-hepatic steatosis, and obese-hepatic steatosis. Then, an intervention study (Study II) will be developed for those children with obesity (i.e., obese-non-hepatic steatosis, and obese-hepatic steatosis groups).
Methodology: A total of 60 children, 8-12 years-old, will be assigned to control (non-overweight children, N= 20), obese-non-hepatic steatosis (children with obesity, but without hepatic steatosis, N=20), and obese-hepatic steatosis (children with obesity and hepatic steatosis, N= 20) groups (Study I: case-control study). The obesity and obesity + hepatic steatosis groups will attend to a 12-weeks healthy lifestyle education program (2 days/month) and home-based exercise program (minimum 3 days/week) (Study II: intervention study).
The combined intervention program for the Study II will include: i) healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and ii) exercise program based on high-intensity interval training which combines aerobic and resistance training (at least 3 days/week, from 38 to 44 min).
Measurements: In the Study I (i.e., case-control study), all participants will be evaluated at baseline. For the Study II (i.e., intervention study), only those participants that belongs to obese-non-hepatic steatosis and obese-hepatic steatosis groups, will be additionally evaluated after the intervention program (12-week). The following outcomes will be measured: hepatic fat fraction and abdominal adiposity (magnetic resonance imaging), intestinal and salivary microbiota, body composition (bioimpedance), cardiometabolic risk factors, liver enzymes, physical fitness (field-fitness tests), physical activity (accelerometry), sleep (accelerometry), dietary habits (24h recalls, and food frequency questionnaires), and pubertal development and sociodemographic characteristics will be measured.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 8 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Obesity defined based on the sex-and-age specific body mass index standards
- •8-12 years old
Exclusion Criteria
- •Medical conditions that hamper their participation in the exercise program
Outcomes
Primary Outcomes
Hepatic fat
Time Frame: baseline and post-test (12-weeks)
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Intestinal microbiota
Time Frame: baseline and post-test (12-weeks)
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Salivary microbiota
Time Frame: baseline and post-test (12-weeks)
Diversity and composition of salivary microbiota before and after 12-weeks intervention program
Secondary Outcomes
- Visceral adiposity(baseline and post-test (12-weeks))
- Fat mass(baseline and post-test (12-weeks))
- Fat-free mass(baseline and post-test (12-weeks))
- Glucose(baseline and post-test (12-weeks))
- Insulin(baseline and post-test (12-weeks))
- Cholesterol(baseline and post-test (12-weeks))
- Triglycerides(baseline and post-test (12-weeks))
- Leptin(baseline and post-test (12-weeks))
- Adiponectin(baseline and post-test (12-weeks))
- C-reactive protein(baseline and post-test (12-weeks))
- Waist circumference(baseline and post-test (12-weeks))
- Systolic and diastolic blood pressure(baseline and post-test (12-weeks))
- Physical fitness(baseline and post-test (12-weeks))
- Physical activity and sleep(baseline and post-test (12-weeks))
- 24h dietary habits(baseline and post-test (12-weeks))
- Dietary habits history(baseline and post-test (12-weeks))
- Subcutaneous abdominal adiposity(baseline and post-test (12-weeks))
- Intermuscular abdominal adiposity(baseline and post-test (12-weeks))
- Weight(baseline and post-test (12-weeks))
- Height(baseline and post-test (12-weeks))