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

University of Copenhagen

Status: Unknown

Conditions: Metabolic Syndrome; Cardiovascular Disease

Treatments: Other: Palm olein vs olive oil and lard

Study type: Interventional

Funder types: Other

Identifiers

NCT00743301

HB2008-056

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Olive oil

Active Comparator group

Treatment:

Other: Palm olein vs olive oil and lard

Palm olein

Experimental group

Treatment:

Other: Palm olein vs olive oil and lard

Lard

Active Comparator group

Treatment:

Other: Palm olein vs olive oil and lard