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

Obesity Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Dyslipoproteinemia
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Obesity
• Prediabetes
• Prediabetic State

• NCT number: NCT02458586
• Study type: Interventional
• Source: German Institute of Human Nutrition
• Contact: Margrit Kemper, Dr.
• Phone: 033 200
• Email: margrit.kemper@dife.de
• Status: Recruiting
• Phase: N/A
• Start date: May 2015
• Completion date: November 2017