Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver
- Conditions
- ObesityMetabolic SyndromeNon-Alcoholic Fatty Liver Disease
- Interventions
- Other: Multidisciplinary intervention program
- Registration Number
- NCT04575506
- Lead Sponsor
- Universidad Pública de Navarra
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Obesity defined based on the sex-and-age specific body mass index standards
- 8-12 years old
- Medical conditions that hamper their participation in the exercise program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Obesity-Non-hepatic steatosis 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). Obesity-Hepatic steatosis 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).
- Primary Outcome Measures
Name Time Method Hepatic fat baseline and post-test (12-weeks) Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Intestinal microbiota baseline and post-test (12-weeks) Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Salivary microbiota baseline and post-test (12-weeks) Diversity and composition of salivary microbiota before and after 12-weeks intervention program
- Secondary Outcome Measures
Name Time Method Visceral adiposity baseline and post-test (12-weeks) Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Fat mass baseline and post-test (12-weeks) Fat mass measured by bioimpedance before and after 12-weeks intervention program
Fat-free mass baseline and post-test (12-weeks) Fat free mass measured by bioimpedance before and after 12-weeks intervention program
Glucose baseline and post-test (12-weeks) Glucose measured by blood analysis before and after 12-weeks intervention program
Insulin baseline and post-test (12-weeks) Serum insulin concentration measured by ELISA before and after 12-weeks intervention program
Cholesterol baseline and post-test (12-weeks) Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program
Triglycerides baseline and post-test (12-weeks) Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program
Leptin baseline and post-test (12-weeks) Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program
Adiponectin baseline and post-test (12-weeks) Plasma adiponectin measured by ELISA before and after 12-weeks intervention program
C-reactive protein baseline and post-test (12-weeks) Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program
Waist circumference baseline and post-test (12-weeks) Waist circumference measured by non-elastic tape before and after 12-weeks intervention program
Systolic and diastolic blood pressure baseline and post-test (12-weeks) Systolic and diastolic blood pressure measured by sphygmomanometer before and after 12-weeks intervention program
Physical fitness baseline and post-test (12-weeks) Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery.
Physical activity and sleep baseline and post-test (12-weeks) Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program
24h dietary habits baseline and post-test (12-weeks) 24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program
Dietary habits history baseline and post-test (12-weeks) Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program
Subcutaneous abdominal adiposity baseline and post-test (12-weeks) Subcutaneous abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Intermuscular abdominal adiposity baseline and post-test (12-weeks) Intermuscular abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Weight baseline and post-test (12-weeks) Weight measured by bioimpedance before and after 12-weeks intervention program
Height baseline and post-test (12-weeks) Height measured by stadiometer before and after 12-weeks intervention program
Trial Locations
- Locations (2)
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Public University of Navarra
🇪🇸Pamplona, Spain