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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Hohenheim.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Hohenheim
ClinicalTrials.gov Identifier:
NCT01306396
First received: February 25, 2011
Last updated: February 28, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Non-alcoholic Fatty Liver Disease
 Behavioral: dietary intervention mainly focusing on fructose reduction

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Hohenheim:

Primary Outcome Measures:
  • prevalence of fatty liver disease [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Prevalence of fatty liver disease in ultrasound examination after 2 years

  • changes in blood lipid concentrations [ Time Frame: 1, 2 years ] [ Designated as safety issue: Yes ]
    changes in TG, HDL, LDL, total choelsterol concentrations in serum

  • changes in blood pressure [ Time Frame: 1, 2 years ] [ Designated as safety issue: Yes ]
    changes in systolic (SBP) and diastolic (DBP) blood pressure

  • changes in glucose metabolism [ Time Frame: 1, 2 years ] [ Designated as safety issue: Yes ]
    changes in oral glucose tolerance-test


Secondary Outcome Measures:
  • Changes in small intestinal bacterial overgrowth [ Time Frame: 1, 2 years ] [ Designated as safety issue: Yes ]
    changes in glucose hydrogen breath test


Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intervention 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 about 50%.
 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.
No Intervention: Control group
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.

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

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306396

Contacts
Contact: Ina Bergheim, Ph.D. ++49/711/4592-4102 ina.bergheim@uni-hohenheim.de

Locations
Germany
University of Hohenheim, Dept. of Nutritional Medicine (180 a) Recruiting
Stuttgart, Baden-Württemberg, Germany, 70599
Contact: Ina Bergheim, Ph.D.     ++49/711/4592-4102     ina.bergheim@uni-hohenheim.de    
Principal Investigator: Ina Bergheim, Ph.D.            
Sponsors and Collaborators
University of Hohenheim
Investigators
Principal Investigator: Ina Bergheim, Ph.D. University of Hohenheim, Dept. of Nutritional Medicine (180 a)
  More Information

No publications provided

Responsible Party: Dr. Ina Bergheim, University of Hohenheim
ClinicalTrials.gov Identifier: NCT01306396     History of Changes
Other Study ID Numbers: 03105084 (IB)
Study First Received: February 25, 2011
Last Updated: February 28, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Hohenheim:
NAFLD
metabolic syndrome
children
fructose

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Metabolic Syndrome X
Digestive System Diseases
 Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013