Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease

NCT06579729 | Completed

• 1 other identifier: 2018140037
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Low-free Sugar Dietary; Child Obesity

Outcome Measures

Primary Outcomes (3)

• NAFLD

  NAFLD was diagnosed using liver ultrasonography with a Phillip IU Elite color Doppler ultrasound after a fasting period to reduce gastrointestinal interference.

  At weeks 1, 12 and 24

• Dietary

  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'.

  At weeks 1, 12 and 24

• Physical activity level

  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.

  At weeks 1, 12 and 24

Secondary Outcomes (6)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: Dietary intervention for low free sugars

Control group

NO INTERVENTION

Interventions

Dietary intervention for low free sugars BEHAVIORAL

After baseline data collection, the intervention group received a 30-60 minute educational session with a dietitian and clinicians, including a health education prescription. Interventions occurred at weeks 1, 12 and 24, with routine evaluations of disease, diet, physical activity, and adherence. Follow-ups at 48 weeks assessed NAFLD extent, dietary profile, and health knowledge for both subjects and guardians.

Intervention group

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

China Medical University

Shenyang, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Pediatric Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 30, 2024
• Study Start: October 1, 2018
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)