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

Not Applicable

• Conditions: Obesity; NAFLD; Dyslipoproteinemia; Prediabetes
• Interventions: Dietary Supplement: Dietary intervention / counseling

• Registration Number: NCT02458586
• Lead Sponsor: German Institute of Human Nutrition

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).

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22
• Primary Completion: 2017-05
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MUFA	Dietary intervention / counseling	daily intake of 50 g of olive oil over a period of 8 weeks
PUFA	Dietary intervention / counseling	daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks

Primary Outcome Measures

Name	Time	Method
change in liver fat content	4 and 8 weeks	change in liver fat content (MR spectroscopy and ultrasound)
change in hepatic insulin sensitivity	8 weeks only	change in hepatic insulin sensitivity (euglycemic hepatic clamp)

Trial Locations

Locations (1)

German Institut for Human Nutrition; Department for Clinical Nutrition; 🇩🇪 Nuthetal, Brandenburg, Germany