NCT Number: NCT04575506
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)
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Notify Me8 year–12 year
All sexes
Interventional
Not applicable
Complejo Hospitalario de Navarra, Pamplona, Spain
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention program includes an educational program promoting healthy dietary habits and physical activity (nutritionist and exercise physiologist) (2 times/month, for children and parents), and supervised home-based exercise (from 3 to 5 times/week, 38-44 min) program for 12-weeks.
Time frame: baseline and post-test (12-weeks)
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Diversity and composition of salivary microbiota before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Subcutaneous abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Intermuscular abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Weight measured by bioimpedance before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Height measured by stadiometer before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Fat mass measured by bioimpedance before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Fat free mass measured by bioimpedance before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Glucose measured by blood analysis before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Serum insulin concentration measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Plasma adiponectin measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Waist circumference measured by non-elastic tape before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Systolic and diastolic blood pressure measured by sphygmomanometer before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery.
Time frame: baseline and post-test (12-weeks)
Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program
Universidad Pública de Navarra
Other
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
Acronym: MicroKid
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