Ernährungs-Interventions-Fettleber-Studie (Interventional Study on Nutritional Effects on NAFLD) (UFOP-2)

German Institute of Human Nutrition

Status: Unknown

Conditions: Prediabetes; Dyslipoproteinemia; Obesity; NAFLD

Treatments: Dietary Supplement: Dietary intervention / counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT02458586

UFOP-2

Details and patient eligibility

About

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).

Full 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).

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

MUFA

Placebo Comparator group

Description:

daily intake of 50 g of olive oil over a period of 8 weeks

Treatment:

Dietary Supplement: Dietary intervention / counseling

PUFA

Active Comparator group

Description:

daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks

Treatment:

Dietary Supplement: Dietary intervention / counseling