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
Recruitment status was Recruiting
Sponsor:
University of Copenhagen
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 27, 2008 | ||||||||
| Last Updated Date | August 27, 2008 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
total, HDL, LDL cholesterol and triacylglycerol [ Time Frame: before and after each type of dietary fat ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease | ||||||||
| Official Title ICMJE | Effects of Palm Olein Versus Olive Oil on Blood Lipids, Lipoproteins and Novel Risk Markers of Cardiovascular Disease | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Palm olein vs olive oil and lard
17E% from test fat is incorporated into three rolls and a piece of cake |
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| Study Arm (s) |
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| Publications * | 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. Epub 2011 Nov 9. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00743301 | ||||||||
| Other Study ID Numbers ICMJE | HB2008-056 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Tine Tholstrup, Dpt Human Nutrition, University of Copenhagen, Denmark | ||||||||
| Study Sponsor ICMJE | University of Copenhagen | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Copenhagen | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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