Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children

Study Overview
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Brief Summary
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The aim of the present study is to find out if a dietary intervention mainly focusing on fructose reduction has a preventive effect on the development and progression of NAFLD and the metabolic syndrome in overweight children.

Detailed Description
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In the intervention study a total of 100 overweight and 50 normal weight children, aged 5-8 years have to be included. At the beginning, two 24-h dietary recalls are performed to assess nutritional intake and fructose consumption. Anthropometric parameters (body weight and height) are measured to calculate BMI and BMI-SDS of the children. Physical activity during leisure time as well as socio-demographic status and family background are assessed using different questionnaires. An ultrasound examination of the liver is performed in all participants for detection of signs of fatty liver. From each child included in the study a fasting blood sample is taken to determine the following blood parameters: ALT, AST, γ-GT, uric acid, blood lipids (TG, HDL, LDL, Total cholesterol), blood alcohol, PAI-1 and endotoxin concentration. A part of the blood sample is used for DNA-analysis. In all children systolic (SBP) and diastolic (DBP) blood pressure are also measured. An oral glucose tolerance test (OGTT) is performed after an overnight fast of 12 h (glucose concentration: 1.75 g/kg body weight, maximum 75g). Simultaneously a glucose hydrogen breath test is performed to assess small intestinal bacterial overgrowth (SIBO). After the check-ups at the beginning of the study, children are divided into two study groups: the intervention group and the control group. Based on the daily fructose intake assessed at the beginning of the study, children participating in the intervention group are advised to reduce their daily fructose intake by 50%. In the first study year, every three months and in the second study year, every six months, nutritional counseling is repeated in small groups in which parents and children are separately trained. If families participating in the control group wish, they receive a dietary counseling based on the references of the DGE at the beginning of the study. After the first and the second study year the examinations are repeated in all participants (ultrasound examination only after the second study year).

Official Title
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Investigation on the Preventive Effect of Reduced Fructose Consumption on the Development of Non-alcoholic Fatty Liver Disease in Children in a Long Term Study

Conditions
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Non-alcoholic Fatty Liver Disease

Intervention / Treatment
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* Behavioral: dietary intervention mainly focusing on fructose reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI > 90 percentile for overweight children BMI < 90 percentile for normal weight children no signs of fatty liver (maximal fatty liver grade one or slightly elevated ALT, AST, γ-GT concentrations) children with metabolic disorders (prehypertension, high triglyceride, cholesterol or fasting glucose levels) are included with agreement of the pediatrics Exclusion Criteria: liver disease (e.g. steatohepatitis) diabetes type 1 and 2 renal insufficiency chronic disease of the gastrointestinal tract taking drugs affecting lipid or glucose metabolism

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group<br>Based on the daily fructose intake assessed at the beginning of the study, children participating in the intervention group are advised to reduce their daily fructose intake about 50%. | Behavioral: dietary intervention mainly focusing on fructose reduction<br>* Based on the daily fructose intake assessed at the beginning of the study, children participating in the intervention group are advised to reduce their daily fructose intake by 50%. In the first study year, every three months and in the second study year, every six months, nutritional counseling is repeated in small groups in which parents and children are separately trained.<br>|
| No Intervention: Control group<br>Families participating in the control group are given only one dietary counseling based on the references of the DGE at the beginning of the study if they wish. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of fatty liver disease | Prevalence of fatty liver disease in ultrasound examination after 2 years | 2 years | 
| changes in blood lipid concentrations | changes in TG, HDL, LDL, total choelsterol concentrations in serum | 1, 2 years | 
| changes in blood pressure | changes in systolic (SBP) and diastolic (DBP) blood pressure | 1, 2 years | 
| changes in glucose metabolism | changes in oral glucose tolerance-test | 1, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in small intestinal bacterial overgrowth | changes in glucose hydrogen breath test | 1, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, metabolic syndrome, children, fructose