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

NCT ID: NCT06579729

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2022-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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NAFLD Low-free Sugar Dietary Child Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention group

Group Type EXPERIMENTAL

Dietary intervention for low free sugars

Intervention Type 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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dietary intervention for low free sugars

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 Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Haonan Zhou

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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China Medical University

Shenyang, , China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2018140037

Identifier Type: -

Identifier Source: org_study_id