Clinical trial NCT04575506: Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Obesity
Metabolic Syndrome
Keywords: Non-alcoholic hepatic steatosis
Obesity
Children
Exercise
Diet
Microbiota
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
First posted: 2020-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hepatic fat
timeFrame: baseline and post-test (12-weeks)
measure: Intestinal microbiota
timeFrame: baseline and post-test (12-weeks)
measure: Salivary microbiota
timeFrame: baseline and post-test (12-weeks)
Secondary outcomes:
measure: Visceral adiposity
timeFrame: baseline and post-test (12-weeks)
measure: Subcutaneous abdominal adiposity
timeFrame: baseline and post-test (12-weeks)
measure: Intermuscular abdominal adiposity
timeFrame: baseline and post-test (12-weeks)
measure: Weight
timeFrame: baseline and post-test (12-weeks)
measure: Height
timeFrame: baseline and post-test (12-weeks)
measure: Fat mass
timeFrame: baseline and post-test (12-weeks)
measure: Fat-free mass
timeFrame: baseline and post-test (12-weeks)
measure: Glucose
timeFrame: baseline and post-test (12-weeks)
measure: Insulin
timeFrame: baseline and post-test (12-weeks)
measure: Cholesterol
timeFrame: baseline and post-test (12-weeks)
measure: Triglycerides
timeFrame: baseline and post-test (12-weeks)
measure: Leptin
timeFrame: baseline and post-test (12-weeks)
measure: Adiponectin
timeFrame: baseline and post-test (12-weeks)
measure: C-reactive protein
timeFrame: baseline and post-test (12-weeks)
measure: Waist circumference
timeFrame: baseline and post-test (12-weeks)
measure: Systolic and diastolic blood pressure
timeFrame: baseline and post-test (12-weeks)
measure: Physical fitness
timeFrame: baseline and post-test (12-weeks)
measure: Physical activity and sleep
timeFrame: baseline and post-test (12-weeks)
measure: 24h dietary habits
timeFrame: baseline and post-test (12-weeks)
measure: Dietary habits history
timeFrame: baseline and post-test (12-weeks)
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Pamplona
country: Spain
facility: Public University of Navarra
Study officials:
References: