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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Complejo Hospitalario de Navarra
Pamplona, Spain
Public University of Navarra
Pamplona, Spain
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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