Clinical trial NCT01306396: Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: NAFLD
metabolic syndrome
children
fructose
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: prevalence of fatty liver disease
timeFrame: 2 years
measure: changes in blood lipid concentrations
timeFrame: 1, 2 years
measure: changes in blood pressure
timeFrame: 1, 2 years
measure: changes in glucose metabolism
timeFrame: 1, 2 years
Secondary outcomes:
measure: Changes in small intestinal bacterial overgrowth
timeFrame: 1, 2 years
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim, Dept. of Nutritional Medicine (180 a)
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim, Dept. of Nutritional Medicine (180 a)
name: Ina Bergheim, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engstler AJ, Aumiller T, Degen C, Durr M, Weiss E, Maier IB, Schattenberg JM, Jin CJ, Sellmann C, Bergheim I. Insulin resistance alters hepatic ethanol metabolism: studies in mice and children with non-alcoholic fatty liver disease. Gut. 2016 Sep;65(9):1564-71. doi: 10.1136/gutjnl-2014-308379. Epub 2015 May 25.
citation: Maier IB, Ozel Y, Wagnerberger S, Bischoff SC, Bergheim I. Dietary pattern and leisure time activity of overweight and normal weight children in Germany: sex-specific differences. Nutr J. 2013 Jan 15;12:14. doi: 10.1186/1475-2891-12-14.