Neural Correlates of an Olive Oil Essence | NCT01716286

Studies
Neural Correlates of an Olive Oil Essence

NCT01716286

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

May 11, 2016Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Neural Correlated of Different Foods

Interventions

low fat vs. essence yoghurt

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

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Oct 18, 2012

First Submission Date that Met QC Criteria

Oct 24, 2012

First Posted Date

Oct 29, 2012Estimated

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

May 10, 2016

Last Update Posted Date

May 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sabine Frank, Principal Investigator, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Name	Class
German Research Foundation	OTHER
German Federation of Industrial Research Associations	OTHER
Zentrum für Ernährungsmedizin und Prävention	OTHER

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

The aim of the current study was to investigate the effect of a low fat meal in comparison to a low fat meal dosed with the fatfree essence of olive oil.

Detailed Description

Not provided

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
yoghurt type	Experimental	low fat yoghurt vs. essence yoghurt	Dietary Supplement: low fat vs. essence yoghurt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low fat vs. essence yoghurt	Dietary Supplement		yoghurt type

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in brain activity (cerebral blood flow change after yogurt intake)		30 minutes before as well as 30 minutes and 120 minutes after yoghurt intake

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male
heatly

Exclusion Criteria:

lactose intolerance
fMRI cotraindications

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

33 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic of Tuebingen, MEG Center		Tübingen		72076	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24025630	Derived	Frank S, Linder K, Fritsche L, Hege MA, Kullmann S, Krzeminski A, Fritsche A, Schieberle P, Somoza V, Hinrichs J, Veit R, Preissl H. Olive oil aroma extract modulates cerebral blood flow in gustatory brain areas in humans. Am J Clin Nutr. 2013 Nov;98(5):1360-6. doi: 10.3945/ajcn.113.062679. Epub 2013 Sep 11.