- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01306396
Effect of Fructose Reduction on Non-alcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome in Overweight Children
28. februar 2011 opdateret af: University of Hohenheim
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
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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Baden-Württemberg
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Stuttgart, Baden-Württemberg, Tyskland, 70599
- Rekruttering
- University of Hohenheim, Dept. of Nutritional Medicine (180 a)
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Kontakt:
- Ina Bergheim, Ph.D.
- Telefonnummer: ++49/711/4592-4102
- E-mail: ina.bergheim@uni-hohenheim.de
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Ledende efterforsker:
- Ina Bergheim, Ph.D.
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
5 år til 8 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: 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%.
|
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.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
prevalence of fatty liver disease
Tidsramme: 2 years
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Prevalence of fatty liver disease in ultrasound examination after 2 years
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2 years
|
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changes in blood lipid concentrations
Tidsramme: 1, 2 years
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changes in TG, HDL, LDL, total choelsterol concentrations in serum
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1, 2 years
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changes in blood pressure
Tidsramme: 1, 2 years
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changes in systolic (SBP) and diastolic (DBP) blood pressure
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1, 2 years
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changes in glucose metabolism
Tidsramme: 1, 2 years
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changes in oral glucose tolerance-test
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1, 2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in small intestinal bacterial overgrowth
Tidsramme: 1, 2 years
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changes in glucose hydrogen breath test
|
1, 2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ina Bergheim, Ph.D., University of Hohenheim, Dept. of Nutritional Medicine (180 a)
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2009
Primær færdiggørelse (Forventet)
1. december 2011
Studieafslutning (Forventet)
1. december 2012
Datoer for studieregistrering
Først indsendt
25. februar 2011
Først indsendt, der opfyldte QC-kriterier
28. februar 2011
Først opslået (Skøn)
1. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. marts 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. februar 2011
Sidst verificeret
1. februar 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 03105084 (IB)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .