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

Primary Purpose

Non-Alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Multidisciplinary intervention program
Sponsored by
Universidad Pública de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring Non-alcoholic hepatic steatosis, Obesity, Children, Exercise, Diet, Microbiota

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts 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

Sites / Locations

  • Complejo Hospitalario de NavarraRecruiting
  • Public University of NavarraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Control group

Obesity-Non-hepatic steatosis

Obesity-Hepatic steatosis

Arm 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).

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).

Outcomes

Primary Outcome Measures

Hepatic fat
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Intestinal microbiota
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Salivary microbiota
Diversity and composition of salivary microbiota before and after 12-weeks intervention program

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2020
Last Updated
March 29, 2021
Sponsor
Universidad Pública de Navarra
Collaborators
Complejo Hospitalario de Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT04575506
Brief Title
Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver
Acronym
MicroKid
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 16, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Pública de Navarra
Collaborators
Complejo Hospitalario de Navarra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
Keywords
Non-alcoholic hepatic steatosis, Obesity, Children, Exercise, Diet, Microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
Obesity-Non-hepatic steatosis
Arm Type
Active Comparator
Arm 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).
Arm Title
Obesity-Hepatic steatosis
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Multidisciplinary intervention program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hepatic fat
Description
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Intestinal microbiota
Description
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Salivary microbiota
Description
Diversity and composition of salivary microbiota before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Secondary Outcome Measure Information:
Title
Visceral adiposity
Description
Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Subcutaneous abdominal adiposity
Description
Subcutaneous abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Intermuscular abdominal adiposity
Description
Intermuscular abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Weight
Description
Weight measured by bioimpedance before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Height
Description
Height measured by stadiometer before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Fat mass
Description
Fat mass measured by bioimpedance before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Fat-free mass
Description
Fat free mass measured by bioimpedance before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Glucose
Description
Glucose measured by blood analysis before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Insulin
Description
Serum insulin concentration measured by ELISA before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Cholesterol
Description
Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Triglycerides
Description
Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Leptin
Description
Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Adiponectin
Description
Plasma adiponectin measured by ELISA before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
C-reactive protein
Description
Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Waist circumference
Description
Waist circumference measured by non-elastic tape before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Systolic and diastolic blood pressure
Description
Systolic and diastolic blood pressure measured by sphygmomanometer before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Physical fitness
Description
Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery.
Time Frame
baseline and post-test (12-weeks)
Title
Physical activity and sleep
Description
Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
24h dietary habits
Description
24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)
Title
Dietary habits history
Description
Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program
Time Frame
baseline and post-test (12-weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idoia Labayen Goñi, PhD
Phone
948166133
Email
idoia.labayen@unavarra.es
Facility Information:
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Félix Sánchez-Valverde Visu
First Name & Middle Initial & Last Name & Degree
Idoia Labayen, PhD
First Name & Middle Initial & Last Name & Degree
Diego Mauricio Peñafiel Freire
First Name & Middle Initial & Last Name & Degree
Félix Sánchez-Valverde Visu, PhD
Facility Name
Public University of Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idoia Labayen, PhD
First Name & Middle Initial & Last Name & Degree
Idoia Labayen, PhD
First Name & Middle Initial & Last Name & Degree
Cristina Cadenas-Sanchez, PhD
First Name & Middle Initial & Last Name & Degree
María Medrano Echeverría, PhD
First Name & Middle Initial & Last Name & Degree
Lide Arenaza Etxeberria, MSc
First Name & Middle Initial & Last Name & Degree
Maddi Osés Recalde, MSc
First Name & Middle Initial & Last Name & Degree
Gerardo Pisabarro De Lucas, PhD
First Name & Middle Initial & Last Name & Degree
Arantxa Villanueva Larre, PhD
First Name & Middle Initial & Last Name & Degree
Rafael Cabeza Laguna, PhD
First Name & Middle Initial & Last Name & Degree
Fernando Idoate Saralegui, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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