The Effect of Palm Olein, Olive Oil and Lard and on Risk... | NCT00743301

Studies
The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease

NCT00743301

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Aug 28, 2008Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Cardiovascular Disease
Metabolic Syndrome

Interventions

Palm olein vs olive oil and lard

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

Aug 2008

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

Aug 2008

Primary Completion Date

Feb 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Aug 27, 2008

First Submission Date that Met QC Criteria

Aug 27, 2008

First Posted Date

Aug 28, 2008Estimated

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

Aug 27, 2008

Last Update Posted Date

Aug 28, 2008Estimated

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 this study is to compare the effects of a diet rich in palm olein, a fraction of palm oil, to a diet rich in olive oil and a diet rich in Danish lard on plasma total-, LDL and HDL cholesterol as well as triacylglycerol (TAG), fasting insulin and glucose, C reactive protein and plasminogen activator inhibitor 1 in healthy men. The investigators hypothesis is that palm olein and olive oil will have the same effect on plasma total cholesterol, LDL- and HDL concentration and maybe also on the secondary outcome parameters that are related to cardiovascular disease risk. This may be caused by the differences in the sn-positioning of palmitic acid in palm olein. This difference may cause the palmitic acid in palm olein to be more prone to soap formations and excretion than palmitic acid from other sources, e.g. lard.

This study is a double blinded, randomized, controlled 3 x 3 week crossover intervention study, without washout periods. The participants receive the three test foods in random order, decided by draw of lots. Blood samples are drawn in duplicate (on two following days) before and after each dietary period.

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

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Olive oil	Active Comparator	Other: Palm olein vs olive oil and lard
Palm olein	Experimental	Other: Palm olein vs olive oil and lard
Lard	Active Comparator	Other: Palm olein vs olive oil and lard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Palm olein vs olive oil and lard	Other	17E% from test fat is incorporated into three rolls and a piece of cake	Lard Olive oil Palm olein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
total, HDL, LDL cholesterol and triacylglycerol		before and after each type of dietary fat

Secondary Outcomes

Measure	Description	Time Frame
fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1		befoer and after each dietary test fat

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All participants must give their informed consent in writing, after having received oral and written information about the study
Age: 18-65 y
BMI: 18.5 - 30 mg/m2
Men
Healthy (no known diseases, incl. hypertension, hypercholesterolemia, diabetes and psoriasis)
No use of dietary supplements or blood donations two month prior to and during the intervention

Exclusion Criteria:

Current or previously cardiovascular disease
Diabetes Mellitus or other severe chronic disease, including severe allergies and psoriasis
Hypertension
Known or suspected abuse of alcohol, drugs or medication
Own request: all participants have the right to withdraw from the intervention at any given time without explanation
Compliance: participants may be excluded from the intervention if they do not follow the study guidelines
Side effects (There are no side effects expected in this study since all test fats are commercial available and use in households world wide)

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
Marianne Raff, PhD	Contact	+4535332533		mrf@life.ku.dk
Tine Tholstrup, PhD	Contact	+4535332486		tth@life.ku.dk

Overall Officials

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

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22071711	Derived	Tholstrup T, Hjerpsted J, Raff M. Palm olein increases plasma cholesterol moderately compared with olive oil in healthy individuals. Am J Clin Nutr. 2011 Dec;94(6):1426-32. doi: 10.3945/ajcn.111.018846. Epub 2011 Nov 9.

ID	Term
D002318	Cardiovascular Diseases
D024821	Metabolic Syndrome

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases