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The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease (A305)

Primary Purpose

Cardiovascular Disease, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Palm olein vs olive oil and lard
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cardiovascular Disease focused on measuring CVD, Palm olein, Olive oil, Lard, healthy men, metabolic syndrome, Risk of cardiovascular disease and metabolic syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Human NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Olive oil

Palm olein

Lard

Arm Description

Outcomes

Primary Outcome Measures

total, HDL, LDL cholesterol and triacylglycerol

Secondary Outcome Measures

fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1

Full Information

First Posted
August 27, 2008
Last Updated
August 27, 2008
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT00743301
Brief Title
The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease
Acronym
A305
Official Title
Effects of Palm Olein Versus Olive Oil on Blood Lipids, Lipoproteins and Novel Risk Markers of Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Metabolic Syndrome
Keywords
CVD, Palm olein, Olive oil, Lard, healthy men, metabolic syndrome, Risk of cardiovascular disease and metabolic syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Olive oil
Arm Type
Active Comparator
Arm Title
Palm olein
Arm Type
Experimental
Arm Title
Lard
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Palm olein vs olive oil and lard
Intervention Description
17E% from test fat is incorporated into three rolls and a piece of cake
Primary Outcome Measure Information:
Title
total, HDL, LDL cholesterol and triacylglycerol
Time Frame
before and after each type of dietary fat
Secondary Outcome Measure Information:
Title
fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1
Time Frame
befoer and after each dietary test fat

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Raff, PhD
Phone
+4535332533
Email
mrf@life.ku.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tine Tholstrup, PhD
Phone
+4535332486
Email
tth@life.ku.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine Tholstrup, PhD
Organizational Affiliation
Department of Human Nutrition, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Human Nutrition
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Raff, PhD
Phone
+4535332533
Email
mrf@life.ku.dk

12. IPD Sharing Statement

Citations:
PubMed Identifier
22071711
Citation
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.
Results Reference
derived

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

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