Clinical trial NCT02458586: Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
Official title: Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: NAFLD
Obesity
Prediabetes
Dyslipoproteinemia
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
Collaborators: name: ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.
First posted: 2015-06-01
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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)

Primary outcomes:
measure: change in liver fat content
timeFrame: 4 and 8 weeks
measure: change in hepatic insulin sensitivity
timeFrame: 8 weeks only
Secondary outcomes:
Other outcomes:
Locations:
city: Nuthetal
country: Germany
facility: German Institut for Human Nutrition; Department for Clinical Nutrition
state: Brandenburg
Study officials:
References: