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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00743301
First received: August 27, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 Intervention
Cardiovascular Disease
Metabolic Syndrome
 Other: Palm olein vs olive oil and lard

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Olive oil
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • total, HDL, LDL cholesterol and triacylglycerol [ Time Frame: before and after each type of dietary fat ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1 [ Time Frame: befoer and after each dietary test fat ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743301

Contacts
Contact: Marianne Raff, PhD +4535332533 mrf@life.ku.dk
Contact: Tine Tholstrup, PhD +4535332486 tth@life.ku.dk

Locations
Denmark
Department of Human Nutrition Recruiting
Frederiksberg, Denmark, 1958
Contact: Marianne Raff, PhD     +4535332533     mrf@life.ku.dk    
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Tine Tholstrup, PhD Department of Human Nutrition, University of Copenhagen
  More Information

No publications provided by University of Copenhagen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00743301     History of Changes
Other Study ID Numbers: HB2008-056
Study First Received: August 27, 2008
Last Updated: August 27, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on June 17, 2013