Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- NAFLD
Study Overview
Brief Summary
A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age: above 5 years old and below 14 years old;
- •Guardian's consent and signing of informed consent;
- •WHO growth and development curves as the reference standard, overweight is defined as BMI greater than or equal to the 85th percentile of the WHO growth curves for children, and obesity is defined as BMI greater than or equal to the 95th percentile of the WHO growth curves for children;
- •Liver imaging performance meets the diagnostic criteria of diffuse fatty liver.
Exclusion Criteria
- •Age <5 years or >14 years;
- •Previous history of alcohol consumption;
- •Non-cooperation with the study, inability to comply with the study treatment or study visit.
- •Past or active hepatitis B virus infection;
- •Past or active hepatitis C virus infection;
- •Chronic or acute liver failure;
- •Cholestasis;
- •Hepatomegaly;
- •Cystic fibrosis;
- •α1-antitrypsin deficiency;
- •Autoimmune hepatitis;
- •Tyrosinemia;
- •Galactosemia or any recognized liver disease, any physical condition deemed by a physician to be unable to complete the trial. Physical Condition.
Arms & Interventions
Intervention group
Intervention: Dietary intervention for low free sugars (Behavioral)
Control group
Outcomes
Primary Outcomes
NAFLD
Time Frame: At weeks 1, 12 and 24
NAFLD was diagnosed using liver ultrasonography with a Phillip IU Elite color Doppler ultrasound after a fasting period to reduce gastrointestinal interference.
Dietary
Time Frame: At weeks 1, 12 and 24
The dietary habits of the subjects were evaluated by a semi-quantitative Food Frequency Questionnaire (FFQ), which was recalled over the past month and included food items, frequency, and amount of intake. The FFQ used in this study covered 72 food items from 11 food groups and 4 frequency categories, including 'average daily, weekly, monthly intake or hardly eat'.
Physical activity level
Time Frame: At weeks 1, 12 and 24
Physical Activity Questionnaire for Children (PAQ-C) was answered by subjects. The PAQ-C reflects the overall physical activity level of children in the past 7 days.The scale consists of 10 items, .and a 1-5 scale was used to obtain a total score by summing the scores of the individual items. The PAQ-C scale scores \< 2.33 defined as low physical activity levels, 2.33-3.66 as moderate physical activity levels, and \>3.66 as high physical activity levels.
Secondary Outcomes
- Height(At weeks 1, 12 and 24)
- Body weight(At weeks 1, 12 and 24)
- BMI(At weeks 1, 12 and 24)
- Waist circumference(At weeks 1, 12 and 24)
- Waist-to-height ratio(At weeks 1, 12 and 24)
- Blood pressure(At weeks 1, 12 and 24)
Investigators
Haonan Zhou
Investigator
China Medical University, China