An interventional study of Multidisciplinary intervention program in Non-Alcoholic Fatty Liver Disease, Obesity and Metabolic Syndrome, sponsored by Universidad Pública de Navarra. Completed at 2 sites in Spain. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Universidad Pública de Navarra · Not applicable, Interventional, and Treatment
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)
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Universidad Pública de Navarra is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and exercise program based on high-intensity interval training which combine aerobic and resistance training (at least 3 days/week, from 38 to 44 min).
Other: Multidisciplinary intervention program
Healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and exercise program based on high-intensity interval training which combine aerobic and resistance training (at least 3 days/week, from 38 to 44 min).
Other: Multidisciplinary intervention program
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.
Hepatic fat
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Intestinal microbiota
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Salivary microbiota
Diversity and composition of salivary microbiota before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Visceral adiposity
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 adiposity
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 adiposity
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
Weight measured by bioimpedance before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Height
Height measured by stadiometer before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Fat mass
Fat mass measured by bioimpedance before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Fat-free mass
Fat free mass measured by bioimpedance before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Glucose
Glucose measured by blood analysis before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Insulin
Serum insulin concentration measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Cholesterol
Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Triglycerides
Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Leptin
Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Adiponectin
Plasma adiponectin measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
C-reactive protein
Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Waist circumference
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
Systolic and diastolic blood pressure measured by sphygmomanometer before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
Physical fitness
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
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
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
Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program
Time frame: baseline and post-test (12-weeks)
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Universidad Pública de Navarra