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Completed

NCT Number: NCT06579729

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

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.

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Key information

Conditions

NAFLD Body Weight Child Obesity Digestive System Diseases Fatty Liver Liver Diseases Low-free Sugar Dietary Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

5 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University

Shenyang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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'.

  3. 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

  1. Height

    Time frame: At weeks 1, 12 and 24

    Height was measured using Height Measuring Ruler (Selcom, Germany) .

  2. Body weight

    Time frame: At weeks 1, 12 and 24

    Body weight was measured using Body Composition Analyzer (DC-13, Parade, Japan).

  3. BMI

    Time frame: At weeks 1, 12 and 24

    BMI (kg/m2) = body weight (kg)/height2 (m2).

  4. Waist circumference

    Time frame: At weeks 1, 12 and 24

    Waist circumference was measured with circumference measuring tape.

  5. Waist-to-height ratio

    Time frame: At weeks 1, 12 and 24

    Waist-to-height ratio (WHtR) = waist circumference (cm)/height (cm).

  6. Blood pressure

    Time frame: At weeks 1, 12 and 24

    Blood pressure was measured using an Omron electronic blood pressure monitor (HBP-1300).

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Official study title

Dietary Intervention for Low Free Sugars in Children With Non-alcoholic Fatty Liver Disease: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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