Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
NCT ID: NCT02458586
Last Updated: 2016-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2015-05-31
2017-11-30
Brief Summary
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The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD.
The study will compare two dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling. Metabolic outcome variables will be assessed with MR spectroscopy (liver fat) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
Detailed Description
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The investigators therefore conduct an interventional trial in subjects with normal glucose metabolism, but increased HCL, fulfilling criteria for NAFLD. The investigation focusses on male participants to avoid sex-related differences in the results.
The study will compare two isocaloric dietary interventions in parallel design, one containing mainly PUFA (canola oil), one containing only MUFA (olive oil). The intervention of 8 weeks is accomodated by dietary counseling (4 sessions). Metabolic outcome variables will be assessed with MR spectroscopy (liver fat), anthropometry (to check for stable weight and body composition) and euglycemic hepatic clamp (glucose metabolism/insulin sensitivity).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MUFA
daily intake of 50 g of olive oil over a period of 8 weeks
Dietary intervention / counseling
dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
PUFA
daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks
Dietary intervention / counseling
dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
Interventions
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Dietary intervention / counseling
dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
Eligibility Criteria
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Inclusion Criteria
* BMI between 30 and 35 kg/m²
Exclusion Criteria
* severe cardiac, pulmonary or gastrointestinal disorders
* hepatic disorders other than NAFLD
* alcoholism
* medication with metabolic side or main effects (e.g. statins)
18 Years
65 Years
MALE
Yes
Sponsors
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ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.
UNKNOWN
German Institute of Human Nutrition
OTHER
Responsible Party
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Prof. Dr. med. Andreas F. H. Pfeiffer
Head of Department of Clinical Nutrition
Locations
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German Institut for Human Nutrition; Department for Clinical Nutrition
Nuthetal, Brandenburg, Germany
Countries
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Central Contacts
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Facility Contacts
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Margrit Kemper, Dr. med.
Role: primary
Silke Hornemann
Role: backup
Other Identifiers
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UFOP-2
Identifier Type: -
Identifier Source: org_study_id