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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Palm Olein Versus Olive Oil on Blood Lipids, Lipoproteins and Novel Risk Markers of Cardiovascular Disease

Conditions
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Cardiovascular Disease, Metabolic Syndrome

Intervention / Treatment
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* Other: Palm olein vs olive oil and lard


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Olive oil<br> | Other: Palm olein vs olive oil and lard<br>* 17E% from test fat is incorporated into three rolls and a piece of cake<br>|
| Experimental: Palm olein<br> | Other: Palm olein vs olive oil and lard<br>* 17E% from test fat is incorporated into three rolls and a piece of cake<br>|
| Active Comparator: Lard<br> | Other: Palm olein vs olive oil and lard<br>* 17E% from test fat is incorporated into three rolls and a piece of cake<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CVD, Palm olein, Olive oil, Lard, healthy men, metabolic syndrome, Risk of cardiovascular disease and metabolic syndrome