Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver (MicroKid)

Universidad Pública de Navarra

Status: Completed

Conditions: Obesity; Metabolic Syndrome; Non-Alcoholic Fatty Liver Disease

Treatments: Other: Multidisciplinary intervention program

Study type: Interventional

Funder types: Other

Identifiers

NCT04575506

PI_2020/29

Details and patient eligibility

About

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)

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Control group

No Intervention group

Obesity-Non-hepatic steatosis

Active Comparator group

Description:

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).

Treatment:

Other: Multidisciplinary intervention program

Obesity-Hepatic steatosis

Experimental group

Description:

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).

Treatment:

Other: Multidisciplinary intervention program