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

August 27, 2008 updated by: University of Copenhagen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1958
        • Recruiting
        • Department of Human Nutrition
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ANTICIPATED)

February 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (ESTIMATE)

August 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 28, 2008

Last Update Submitted That Met QC Criteria

August 27, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB2008-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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