NCT04575506

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

November 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

June 13, 2025

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 29, 2020

Last Update Submit

June 10, 2025

Conditions

Non-Alcoholic Fatty Liver DiseaseObesityMetabolic Syndrome

Keywords

Non-alcoholic hepatic steatosisObesityChildrenExerciseDietMicrobiota

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (20)

  • Visceral adiposity

    baseline and post-test (12-weeks)

  • Subcutaneous abdominal adiposity

    baseline and post-test (12-weeks)

  • Intermuscular abdominal adiposity

    baseline and post-test (12-weeks)

  • Weight

    baseline and post-test (12-weeks)

  • Height

    baseline and post-test (12-weeks)

  • +15 more secondary outcomes

Study Arms (3)

Control group

NO INTERVENTION

Obesity-Non-hepatic steatosis

ACTIVE COMPARATOR

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

Obesity-Hepatic steatosis

EXPERIMENTAL

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

Interventions

Multidisciplinary intervention programOTHER

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.

Obesity-Hepatic steatosisObesity-Non-hepatic steatosis

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Obesity defined based on the sex-and-age specific body mass index standards
  • years old

You may not qualify if:

  • Medical conditions that hamper their participation in the exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Public University of Navarra

Pamplona, Spain

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityMetabolic SyndromeMotor Activity

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 5, 2020

Study Start

November 16, 2020

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

June 13, 2025

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)