Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)

Study Overview
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Brief Summary
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Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). 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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Epidemiological data and studies in animal models suggest, that polyunsatured fatty acids (PUFA) rather than mono-unsatured fatty acids (MUFA) are associated with lower hepatic lipid content (HCL) and may facilitate a decrease of HCL in case of non-alcoholic fatty liver disease (NAFLD). A typical source for PUFAs are fish and certain plant oils, a source of almost pure MUFAs is olive oil. 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).

Official Title
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Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)

Conditions
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NAFLD, Obesity, Prediabetes, Dyslipoproteinemia

Intervention / Treatment
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* Dietary Supplement: Dietary intervention / counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: increased hepatic fat content (NAFLD) BMI between 30 and 35 kg/m² Exclusion Criteria: diabetes severe cardiac, pulmonary or gastrointestinal disorders hepatic disorders other than NAFLD alcoholism medication with metabolic side or main effects (e.g. statins)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: MUFA<br>daily intake of 50 g of olive oil over a period of 8 weeks | Dietary Supplement: Dietary intervention / counseling<br>* dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks<br>|
| Active Comparator: PUFA<br>daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks | Dietary Supplement: Dietary intervention / counseling<br>* dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in liver fat content | change in liver fat content (MR spectroscopy and ultrasound) | 4 and 8 weeks | 
| change in hepatic insulin sensitivity | change in hepatic insulin sensitivity (euglycemic hepatic clamp) | 8 weeks only |