NCT01306396

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

2.7 years

First QC Date

February 25, 2011

Last Update Submit

February 28, 2011

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

NAFLDmetabolic syndromechildrenfructose

Outcome Measures

Primary Outcomes (4)

  • prevalence of fatty liver disease

    Prevalence of fatty liver disease in ultrasound examination after 2 years

    2 years

  • changes in blood lipid concentrations

    changes in TG, HDL, LDL, total choelsterol concentrations in serum

    1, 2 years

  • changes in blood pressure

    changes in systolic (SBP) and diastolic (DBP) blood pressure

    1, 2 years

  • changes in glucose metabolism

    changes in oral glucose tolerance-test

    1, 2 years

Secondary Outcomes (1)

  • Changes in small intestinal bacterial overgrowth

    1, 2 years

Study Arms (2)

Intervention group

OTHER

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

Control group

NO INTERVENTION

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.

Interventions

dietary intervention mainly focusing on fructose reductionBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim, Dept. of Nutritional Medicine (180 a)

Stuttgart, Baden-Wurttemberg, 70599, Germany

RECRUITING

Related Publications (2)

  • 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.

    PMID: 26006114DERIVED

  • 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.

    PMID: 23320866DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ina Bergheim, Ph.D.

    University of Hohenheim, Dept. of Nutritional Medicine (180 a)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ina Bergheim, Ph.D.

CONTACT

++49/711/4592-4102ina.bergheim@uni-hohenheim.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2011

First Posted

March 1, 2011

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations

DE(1)