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

NCT02458586 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-11-22

No results posted yet for this study

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).

Conditions

Interventions

DIETARY_SUPPLEMENT

Dietary intervention / counseling

dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks

Sponsors & Collaborators

  • ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.

    collaborator UNKNOWN

  • German Institute of Human Nutrition

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2017-05-31
Completion
2017-11-30

Countries

  • Germany

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02458586 on ClinicalTrials.gov