Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01306396|
Recruitment Status : Unknown
Verified February 2011 by University of Hohenheim.
Recruitment status was: Recruiting
First Posted : March 1, 2011
Last Update Posted : March 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Non-alcoholic Fatty Liver Disease||Behavioral: dietary intervention mainly focusing on fructose reduction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2009|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2012|
U.S. FDA Resources
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.
- prevalence of fatty liver disease [ Time Frame: 2 years ]Prevalence of fatty liver disease in ultrasound examination after 2 years
- changes in blood lipid concentrations [ Time Frame: 1, 2 years ]changes in TG, HDL, LDL, total choelsterol concentrations in serum
- changes in blood pressure [ Time Frame: 1, 2 years ]changes in systolic (SBP) and diastolic (DBP) blood pressure
- changes in glucose metabolism [ Time Frame: 1, 2 years ]changes in oral glucose tolerance-test
- Changes in small intestinal bacterial overgrowth [ Time Frame: 1, 2 years ]changes in glucose hydrogen breath test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01306396
|Contact: Ina Bergheim, Ph.D.||++firstname.lastname@example.org|
|University of Hohenheim, Dept. of Nutritional Medicine (180 a)||Recruiting|
|Stuttgart, Baden-Württemberg, Germany, 70599|
|Contact: Ina Bergheim, Ph.D. ++49/711/4592-4102 email@example.com|
|Principal Investigator: Ina Bergheim, Ph.D.|
|Principal Investigator:||Ina Bergheim, Ph.D.||University of Hohenheim, Dept. of Nutritional Medicine (180 a)|