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

Obesity Clinical Trial

— UFOP-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02458586
• Other study ID #: UFOP-2
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2015
• Last updated: November 21, 2016
• Start date: May 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: German Institute of Human Nutrition
• Contact: Margrit Kemper, Dr.
• Phone: 033 200
• Email: margrit.kemper[@]dife.de
• Is FDA regulated: No
• Health authority: Ethics committee, University of Potsdam, Germany:
• Study type: Interventional

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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

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

Intervention

Dietary Supplement:
• Dietary intervention / counseling
dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks

Locations

Country	Name	City	State
Germany	German Institut for Human Nutrition; Department for Clinical Nutrition	Nuthetal	Brandenburg

Sponsors (2)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in liver fat content	change in liver fat content (MR spectroscopy and ultrasound)	4 and 8 weeks	No
Primary	change in hepatic insulin sensitivity	change in hepatic insulin sensitivity (euglycemic hepatic clamp)	8 weeks only	No