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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743301
Recruitment Status : Unknown
Verified August 2008 by University of Copenhagen.
Recruitment status was:  Recruiting
First Posted : August 28, 2008
Last Update Posted : August 28, 2008
Information provided by:
University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Metabolic Syndrome Other: Palm olein vs olive oil and lard Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Palm Olein Versus Olive Oil on Blood Lipids, Lipoproteins and Novel Risk Markers of Cardiovascular Disease
Study Start Date : August 2008
Estimated Primary Completion Date : February 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Active Comparator: Olive oil Other: Palm olein vs olive oil and lard
17E% from test fat is incorporated into three rolls and a piece of cake

Experimental: Palm olein Other: Palm olein vs olive oil and lard
17E% from test fat is incorporated into three rolls and a piece of cake

Active Comparator: Lard Other: Palm olein vs olive oil and lard
17E% from test fat is incorporated into three rolls and a piece of cake

Primary Outcome Measures :
  1. total, HDL, LDL cholesterol and triacylglycerol [ Time Frame: before and after each type of dietary fat ]

Secondary Outcome Measures :
  1. fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1 [ Time Frame: befoer and after each dietary test fat ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743301

Contact: Marianne Raff, PhD +4535332533
Contact: Tine Tholstrup, PhD +4535332486

Department of Human Nutrition Recruiting
Frederiksberg, Denmark, 1958
Contact: Marianne Raff, PhD    +4535332533   
Sponsors and Collaborators
University of Copenhagen
Principal Investigator: Tine Tholstrup, PhD Department of Human Nutrition, University of Copenhagen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark Identifier: NCT00743301     History of Changes
Other Study ID Numbers: HB2008-056
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: August 28, 2008
Last Verified: August 2008

Keywords provided by University of Copenhagen:
Palm olein
Olive oil
healthy men
metabolic syndrome
Risk of cardiovascular disease and metabolic syndrome

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases