Effect of Dairy Fat on Plasma Phytanic Acid in Human | NCT01343576

Studies
Effect of Dairy Fat on Plasma Phytanic Acid in Human

NCT01343576

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Apr 28, 2011Estimated

Enrollment

14Actual

Phase

Not Applicable

Conditions

Coronary Heart Disease

Interventions

milk fat

Countries

Denmark

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 2009

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

Aug 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Apr 18, 2011

First Submission Date that Met QC Criteria

Apr 26, 2011

First Posted Date

Apr 28, 2011Estimated

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

Apr 26, 2011

Last Update Posted Date

Apr 28, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Name	Class
The Danish Dairy Research Foundation, Denmark	OTHER
The Danish Council for Strategic Research	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 study is to investigate if cow feeding regimes affects concentration of plasma phytanic acid and risk markers of the metabolic syndrome in human.

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

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
milk fat	Dietary Supplement	45 g milk fat per day in 4 weeks		yellow group Green group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma phytanic acid		before and after the intervention (4 weeks)

Secondary Outcomes

Measure	Description	Time Frame
total cholesterol		before and after the intervention (4 weeks)
LDL cholesterol		before and after the intervention (4 weeks)
HDL cholesterol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

sign written consent
Age: 20-42
BMI: 20-30
increased risk of developing MS
refrain from dietary supplements and blood donations prior to, and during the study

Exclusion Criteria:

poor compliance
if they suffering from any chronic or long lasting illness
abuse of alcohol or medicine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tine Tholstrup, lector	Department of Human Nutrition, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Human Nutrition		Frederiksberg		1958	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21663648	Derived	Werner LB, Hellgren LI, Raff M, Jensen SK, Petersen RA, Drachmann T, Tholstrup T. Effect of dairy fat on plasma phytanic acid in healthy volunteers - a randomized controlled study. Lipids Health Dis. 2011 Jun 10;10:95. doi: 10.1186/1476-511X-10-95.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases