Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children
Primary Purpose
Non-alcoholic Fatty Liver Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
dietary intervention mainly focusing on fructose reduction
Sponsored by
About this trial
This is an interventional prevention trial for Non-alcoholic Fatty Liver Disease focused on measuring NAFLD, metabolic syndrome, children, fructose
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
Sites / Locations
- University of Hohenheim, Dept. of Nutritional Medicine (180 a)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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%.
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.
Outcomes
Primary Outcome Measures
prevalence of fatty liver disease
Prevalence of fatty liver disease in ultrasound examination after 2 years
changes in blood lipid concentrations
changes in TG, HDL, LDL, total choelsterol concentrations in serum
changes in blood pressure
changes in systolic (SBP) and diastolic (DBP) blood pressure
changes in glucose metabolism
changes in oral glucose tolerance-test
Secondary Outcome Measures
Changes in small intestinal bacterial overgrowth
changes in glucose hydrogen breath test
Full Information
NCT ID
NCT01306396
First Posted
February 25, 2011
Last Updated
February 28, 2011
Sponsor
University of Hohenheim
1. Study Identification
Unique Protocol Identification Number
NCT01306396
Brief Title
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
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Hohenheim
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
NAFLD, metabolic syndrome, children, fructose
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Other
Arm Description
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%.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
dietary intervention mainly focusing on fructose reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
prevalence of fatty liver disease
Description
Prevalence of fatty liver disease in ultrasound examination after 2 years
Time Frame
2 years
Title
changes in blood lipid concentrations
Description
changes in TG, HDL, LDL, total choelsterol concentrations in serum
Time Frame
1, 2 years
Title
changes in blood pressure
Description
changes in systolic (SBP) and diastolic (DBP) blood pressure
Time Frame
1, 2 years
Title
changes in glucose metabolism
Description
changes in oral glucose tolerance-test
Time Frame
1, 2 years
Secondary Outcome Measure Information:
Title
Changes in small intestinal bacterial overgrowth
Description
changes in glucose hydrogen breath test
Time Frame
1, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ina Bergheim, Ph.D.
Phone
++49/711/4592-4102
Email
ina.bergheim@uni-hohenheim.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ina Bergheim, Ph.D.
Organizational Affiliation
University of Hohenheim, Dept. of Nutritional Medicine (180 a)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hohenheim, Dept. of Nutritional Medicine (180 a)
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70599
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ina Bergheim, Ph.D.
Phone
++49/711/4592-4102
Email
ina.bergheim@uni-hohenheim.de
First Name & Middle Initial & Last Name & Degree
Ina Bergheim, Ph.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
26006114
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.
Results Reference
derived
PubMed Identifier
23320866
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.
Results Reference
derived
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Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children
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