Non-Alcoholic Fatty Liver DiseaseMicroKidNCT04575506
Influence of the Diversity and Composition of the Microbiota in the Development of Pediatric Fatty Liver
A study testing Multidisciplinary intervention program in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Universidad Pública de Navarra at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
- What is being tested?
- Multidisciplinary intervention program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Nov 2020to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Obesity defined based on the sex-and-age specific body mass index standards
- 8-12 years old
Who cannot join
- Medical conditions that hamper their participation in the exercise program
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Complejo Hospitalario de Navarra
Pamplona
Public University of Navarra
Pamplona
About this study
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
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)
Read the 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.
- Being tested
- Multidisciplinary intervention program
- Keywords
- Non-alcoholic hepatic steatosis, Obesity, Children, Exercise, Diet, Microbiota
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| 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). Receives: 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). Receives: Other: Multidisciplinary intervention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic fat
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Intestinal microbiota
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Salivary microbiota
Diversity and composition of salivary microbiota before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Secondary outcomes (20)
Visceral adiposity
Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
Measured: 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
Measured: 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
Measured: baseline and post-test (12-weeks)
Weight
Weight measured by bioimpedance before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Height
Height measured by stadiometer before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Fat mass
Fat mass measured by bioimpedance before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Fat-free mass
Fat free mass measured by bioimpedance before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Glucose
Glucose measured by blood analysis before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Insulin
Serum insulin concentration measured by ELISA before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Cholesterol
Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Triglycerides
Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Leptin
Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Adiponectin
Plasma adiponectin measured by ELISA before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
C-reactive protein
Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Waist circumference
Waist circumference measured by non-elastic tape before and after 12-weeks intervention program
Measured: 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
Measured: baseline and post-test (12-weeks)
Physical fitness
Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery.
Measured: baseline and post-test (12-weeks)
Physical activity and sleep
Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
24h dietary habits
24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Dietary habits history
Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program
Measured: baseline and post-test (12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Nov 2020
- Primary completion30 Sep 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575506
- Sponsor's protocol ID
- PI_2020/29
- Acronym
- MicroKid
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04575506
- Acronym / sponsor ID
- MicroKid / PI_2020/29
- Keywords
- Non-alcoholic hepatic steatosis, Obesity, Children, Exercise, Diet, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Obesity-Non-hepatic steatosis | Active comparator | Other: Multidisciplinary intervention programHealthy 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). |
| Obesity-Hepatic steatosis | Experimental | Other: Multidisciplinary intervention programHealthy 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). |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Obesity defined based on the sex-and-age specific body mass index standards
- 8-12 years old
Key exclusion criteria (1 listed)
- Medical conditions that hamper their participation in the exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary intervention programThe 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. | Other | Obesity-Hepatic steatosis, Obesity-Non-hepatic steatosis |
Primary outcome
Hepatic fat
Time frame: baseline and post-test (12-weeks)
Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program
Intestinal microbiota
Time frame: baseline and post-test (12-weeks)
Diversity and composition of intestinal microbiota before and after 12-weeks intervention program
Salivary microbiota
Time frame: baseline and post-test (12-weeks)
Diversity and composition of salivary microbiota before and after 12-weeks intervention program
20 secondary outcomes
Visceral adiposity
Time frame: baseline and post-test (12-weeks)
Subcutaneous abdominal adiposity
Time frame: baseline and post-test (12-weeks)
Intermuscular abdominal adiposity
Time frame: baseline and post-test (12-weeks)
Weight
Time frame: baseline and post-test (12-weeks)
Height
Time frame: baseline and post-test (12-weeks)
Fat mass
Time frame: baseline and post-test (12-weeks)
Fat-free mass
Time frame: baseline and post-test (12-weeks)
Glucose
Time frame: baseline and post-test (12-weeks)
Insulin
Time frame: baseline and post-test (12-weeks)
Cholesterol
Time frame: baseline and post-test (12-weeks)
Triglycerides
Time frame: baseline and post-test (12-weeks)
Leptin
Time frame: baseline and post-test (12-weeks)
Adiponectin
Time frame: baseline and post-test (12-weeks)
C-reactive protein
Time frame: baseline and post-test (12-weeks)
Waist circumference
Time frame: baseline and post-test (12-weeks)
Systolic and diastolic blood pressure
Time frame: baseline and post-test (12-weeks)
Physical fitness
Time frame: baseline and post-test (12-weeks)
Physical activity and sleep
Time frame: baseline and post-test (12-weeks)
24h dietary habits
Time frame: baseline and post-test (12-weeks)
Dietary habits history
Time frame: baseline and post-test (12-weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary intervention program in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Universidad Pública de Navarra at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic fat (time frame: baseline and post-test (12-weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.