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

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

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)

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: Multidisciplinary intervention program

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Pamplona, Spain
    • Complejo Hospitalario de Navarra
  • Pamplona, Spain
    • Public University of Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Active Comparator: Obesity-Non-hepatic steatosis; 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.
Experimental: Obesity-Hepatic steatosis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic fat	Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Intestinal microbiota	Diversity and composition of intestinal microbiota before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Salivary microbiota	Diversity and composition of salivary microbiota before and after 12-weeks intervention program	baseline and post-test (12-weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral adiposity	Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program	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	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	baseline and post-test (12-weeks)
Weight	Weight measured by bioimpedance before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Height	Height measured by stadiometer before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Fat mass	Fat mass measured by bioimpedance before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Fat-free mass	Fat free mass measured by bioimpedance before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Glucose	Glucose measured by blood analysis before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Insulin	Serum insulin concentration measured by ELISA before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Cholesterol	Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Triglycerides	Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Leptin	Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Adiponectin	Plasma adiponectin measured by ELISA before and after 12-weeks intervention program	baseline and post-test (12-weeks)
C-reactive protein	Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Waist circumference	Waist circumference measured by non-elastic tape before and after 12-weeks intervention program	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	baseline and post-test (12-weeks)
Physical fitness	Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery.	baseline and post-test (12-weeks)
Physical activity and sleep	Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program	baseline and post-test (12-weeks)
24h dietary habits	24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program	baseline and post-test (12-weeks)
Dietary habits history	Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program	baseline and post-test (12-weeks)

Collaborators and Investigators

• Sponsor: Universidad Pública de Navarra
• Collaborators: Complejo Hospitalario de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 29, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Obesity; Children; Microbiota; Diet; Non-alcoholic hepatic steatosis
• Additional Relevant MeSH Terms: Metabolic Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: PI_2020/29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No