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

Metabolic Syndrome Clinical Trial

— A305  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00743301
• Other study ID #: HB2008-056
• Status: Recruiting
• Phase: N/A
• First received: August 27, 2008
• Last updated: August 27, 2008
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: University of Copenhagen
• Contact: Marianne Raff, PhD
• Phone: +4535332533
• Email: mrf[@]life.ku.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition	Frederiksberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total, HDL, LDL cholesterol and triacylglycerol		before and after each type of dietary fat	No
Secondary	fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1		befoer and after each dietary test fat	No