Ernährungs-Interventions-Fettleber-Studie (Interventional... | NCT02458586

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

NCT02458586

Sponsor

German Institute of Human Nutrition

Status

Unknown status

Last Update Posted

Nov 22, 2016Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

NAFLD
Obesity
Prediabetes
Dyslipoproteinemia

Interventions

Dietary intervention / counseling

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

May 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

May 28, 2015

First Submission Date that Met QC Criteria

May 28, 2015

First Posted Date

Jun 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2016

Last Update Posted Date

Nov 22, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. med. Andreas F. H. Pfeiffer, Head of Department of Clinical Nutrition, German Institute of Human NutritionPrincipal Investigator

Lead Sponsor

German Institute of Human NutritionOTHER

Collaborators

Name	Class
ufop: Union zur Förderung von Oel- und Proteinpflanzen e.V.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dietary intervention / counseling	Dietary Supplement	dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks	MUFA PUFA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Margrit Kemper, Dr.	Contact	033 200	88 2775	margrit.kemper@dife.de
Berit Schmidt	Contact	033 200	88 2771	berit.schmidt@dife.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
German Institut for Human Nutrition; Department for Clinical Nutrition	Recruiting	Nuthetal	Brandenburg	14458	Germany

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D009765	Obesity
D011236	Prediabetic State
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D050177	Overweight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004035	Diet Therapy
D003376	Counseling

Ancestor Terms

ID	Term
D044623	Nutrition Therapy
D013812	Therapeutics
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided