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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01306396
Enrollment
100
Registered
2011-03-01
Start date
2009-04-30
Completion date
2012-12-31
Last updated
2011-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

NAFLD, metabolic syndrome, children, fructose

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).

Interventions

BEHAVIORALdietary 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.

Sponsors

University of Hohenheim
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of fatty liver disease2 yearsPrevalence of fatty liver disease in ultrasound examination after 2 years
changes in blood lipid concentrations1, 2 yearschanges in TG, HDL, LDL, total choelsterol concentrations in serum
changes in blood pressure1, 2 yearschanges in systolic (SBP) and diastolic (DBP) blood pressure
changes in glucose metabolism1, 2 yearschanges in oral glucose tolerance-test

Secondary

MeasureTime frameDescription
Changes in small intestinal bacterial overgrowth1, 2 yearschanges in glucose hydrogen breath test

Countries

Germany

Contacts

Primary ContactIna Bergheim, Ph.D.
ina.bergheim@uni-hohenheim.de++49/711/4592-4102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026