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

C

China Medical University, China

Status

Completed

Conditions

Low-free Sugar Dietary
NAFLD
Child Obesity

Treatments

Behavioral: Dietary intervention for low free sugars

Study type

Interventional

Funder types

Other

Identifiers

NCT06579729
2018140037

Details and patient eligibility

About

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.

Enrollment

146 patients

Sex

All

Ages

5 to 14 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

146 participants in 2 patient groups

Intervention group
Experimental group
Treatment:
Behavioral: Dietary intervention for low free sugars
Control group
No Intervention group

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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