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

Non-alcoholic Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01306396
• Other study ID #: 03105084 (IB)
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2011
• Last updated: February 28, 2011
• Start date: April 2009
• Est. completion date: December 2012

Study information

• Verified date: February 2011
• Source: University of Hohenheim
• Contact: Ina Bergheim, Ph.D.
• Phone: ++49/711/4592-4102
• Email: ina.bergheim[@]uni-hohenheim.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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, ?-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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• dietary intervention mainly focusing on fructose reduction
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.

Locations

Country	Name	City	State
Germany	University of Hohenheim, Dept. of Nutritional Medicine (180 a)	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of fatty liver disease	Prevalence of fatty liver disease in ultrasound examination after 2 years	2 years	Yes
Primary	changes in blood lipid concentrations	changes in TG, HDL, LDL, total choelsterol concentrations in serum	1, 2 years	Yes
Primary	changes in blood pressure	changes in systolic (SBP) and diastolic (DBP) blood pressure	1, 2 years	Yes
Primary	changes in glucose metabolism	changes in oral glucose tolerance-test	1, 2 years	Yes
Secondary	Changes in small intestinal bacterial overgrowth	changes in glucose hydrogen breath test	1, 2 years	Yes