Clinical trial NCT00743301: The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease
Official title: Effects of Palm Olein Versus Olive Oil on Blood Lipids, Lipoproteins and Novel Risk Markers of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Metabolic Syndrome
Keywords: CVD
Palm olein
Olive oil
Lard
healthy men
metabolic syndrome
Risk of cardiovascular disease and metabolic syndrome
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: total, HDL, LDL cholesterol and triacylglycerol
timeFrame: before and after each type of dietary fat
Secondary outcomes:
measure: fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1
timeFrame: befoer and after each dietary test fat
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Human Nutrition
Study officials:
affiliation: Department of Human Nutrition, University of Copenhagen
name: Tine Tholstrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.