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

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575506
• Other study ID #: PI_2020/29
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: September 2020
• Source: Universidad Pública de Navarra
• Contact: Idoia Labayen Goñi, PhD
• Phone: 948166133
• Email: idoia.labayen[@]unavarra.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-Alcoholic Fatty Liver Disease
• Obesity

Intervention

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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona
Spain	Public University of Navarra	Pamplona

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Pública de Navarra	Complejo Hospitalario de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

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