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

NCT ID: NCT00743301

Last Updated: 2008-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease Metabolic Syndrome

Keywords

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CVD Palm olein Olive oil Lard healthy men metabolic syndrome Risk of cardiovascular disease and metabolic syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Olive oil

Group Type ACTIVE_COMPARATOR

Palm olein vs olive oil and lard

Intervention Type OTHER

17E% from test fat is incorporated into three rolls and a piece of cake

Palm olein

Group Type EXPERIMENTAL

Palm olein vs olive oil and lard

Intervention Type OTHER

17E% from test fat is incorporated into three rolls and a piece of cake

Lard

Group Type ACTIVE_COMPARATOR

Palm olein vs olive oil and lard

Intervention Type OTHER

17E% from test fat is incorporated into three rolls and a piece of cake

Interventions

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Palm olein vs olive oil and lard

17E% from test fat is incorporated into three rolls and a piece of cake

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Dpt Human Nutrition, University of Copenhagen, Denmark

Principal Investigators

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Tine Tholstrup, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Human Nutrition, University of Copenhagen

Locations

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Department of Human Nutrition

Frederiksberg, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Marianne Raff, PhD

Role: CONTACT

Phone: +4535332533

Email: [email protected]

Tine Tholstrup, PhD

Role: CONTACT

Phone: +4535332486

Email: [email protected]

Facility Contacts

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Marianne Raff, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 22071711 (View on PubMed)

Other Identifiers

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HB2008-056

Identifier Type: -

Identifier Source: org_study_id