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

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).

Study Overview

• Status: Unknown
• Conditions: Obesity; NAFLD; Prediabetes; Dyslipoproteinemia
• Intervention / Treatment: Dietary supplement: Dietary intervention / counseling

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margrit Kemper, Dr.; Phone Number: 88 2775 033 200; Email: margrit.kemper@dife.de
• Study Contact Backup: Name: Berit Schmidt; Phone Number: 88 2771 033 200; Email: berit.schmidt@dife.de

Study Locations

• Germany
  • Brandenburg
    • Nuthetal, Brandenburg, Germany, 14458
      • Recruiting
      • German Institut for Human Nutrition; Department for Clinical Nutrition
      • Contact: Margrit Kemper, Dr. med.; Phone Number: 033200 88 2775; Email: margrit.kemper@dife.de
      • Contact: Silke Hornemann; Phone Number: 033200 88 2779; Email: silke.hornemann@dife.de
      • Sub-Investigator: Margrit Kemper, Dr. med.
      • Sub-Investigator: Silke Hornemann
      • Sub-Investigator: Christiana Gerbracht, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: MUFA; daily intake of 50 g of olive oil over a period of 8 weeks	Dietary supplement: Dietary intervention / counseling; dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
Active Comparator: PUFA; daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks	Dietary supplement: Dietary intervention / counseling; dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: German Institute of Human Nutrition
• Collaborators: ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: May 28, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 1, 2015

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Liver Diseases; Lipid Metabolism Disorders; Fatty Liver; Dyslipidemias; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: UFOP-2