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

NCT02458586 | Unknown

• 1 other identifier: UFOP-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

NAFLD; Obesity; Prediabetes; Dyslipoproteinemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

MUFA

PLACEBO COMPARATOR

daily intake of 50 g of olive oil over a period of 8 weeks

Dietary Supplement: Dietary intervention / counseling

PUFA

ACTIVE COMPARATOR

daily intake of 50 g of canola oil (rapeseed oil) over a period of 8 weeks

Dietary Supplement: Dietary intervention / counseling

Interventions

Dietary intervention / counseling DIETARY_SUPPLEMENT

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

MUFA; PUFA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• increased hepatic fat content (NAFLD)
• BMI between 30 and 35 kg/m²

You may not qualify if:

• diabetes
• severe cardiac, pulmonary or gastrointestinal disorders
• hepatic disorders other than NAFLD
• alcoholism
• medication with metabolic side or main effects (e.g. statins)

Sponsors & Collaborators

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

Study Sites (1)

German Institut for Human Nutrition; Department for Clinical Nutrition

Nuthetal, Brandenburg, 14458, Germany

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Prediabetic State; Dyslipidemias

Interventions

Diet Therapy; Counseling

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Margrit Kemper, Dr.

CONTACT

033 200; margrit.kemper@dife.de

Berit Schmidt

CONTACT

033 200; berit.schmidt@dife.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Clinical Nutrition

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

DE (1)