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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04575506
Other study ID # PI_2020/29
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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