Cardiovascular DiseaseA305NCT00743301
The Effect of Palm Olein, Olive Oil and Lard and on Risk Markers of Cardiovascular Disease
A study testing Palm olein vs olive oil and lard in people with Cardiovascular Disease and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Metabolic Syndrome
- What is being tested?
- Palm olein vs olive oil and lard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants must give their informed consent in writing, after having received oral and written information about the study
- Age: 18-65 y
- BMI: 18.5 - 30 mg/m2
- Men
- Healthy (no known diseases, incl. hypertension, hypercholesterolemia, diabetes and psoriasis)
- No use of dietary supplements or blood donations two month prior to and during the intervention
Who cannot join
- Current or previously cardiovascular disease
- Diabetes Mellitus or other severe chronic disease, including severe allergies and psoriasis
- Hypertension
- Known or suspected abuse of alcohol, drugs or medication
- Own request: all participants have the right to withdraw from the intervention at any given time without explanation
- Compliance: participants may be excluded from the intervention if they do not follow the study guidelines
- Side effects (There are no side effects expected in this study since all test fats are commercial available and use in households world wide)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Human Nutrition
Frederiksberg, 1958
Marianne Raff, PhD, +4535332533, mrf@life.ku.dk
About this study
Official title: 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.
- Conditions
- Cardiovascular Disease, Metabolic Syndrome
- Being tested
- Palm olein vs olive oil and lard
- Keywords
- CVD, Palm olein, Olive oil, Lard, healthy men, metabolic syndrome, Risk of cardiovascular disease and metabolic syndrome
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm olein vs olive oil and lardOther
17E% from test fat is incorporated into three rolls and a piece of cake
| Study group | Role | What they receive |
|---|---|---|
| Olive oil | Active comparator | Not described Receives: Other: Palm olein vs olive oil and lard |
| Palm olein | Experimental | Not described Receives: Other: Palm olein vs olive oil and lard |
| Lard | Active comparator | Not described Receives: Other: Palm olein vs olive oil and lard |
What is being measured
The primary outcome is the main question the study is designed to answer.
total, HDL, LDL cholesterol and triacylglycerol
Measured: before and after each type of dietary fat
Secondary outcomes (1)
fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1
Measured: befoer and after each dietary test fat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Tine Tholstrup, PhD, Principal investigator, Department of Human Nutrition, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00743301
- Sponsor's protocol ID
- HB2008-056
- Acronym
- A305
- Status last verified
- Aug 2008
- First submitted
- 27 Aug 2008
- Last updated
- 28 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.3945/ajcn.111.018846. Epub 2011 Nov 9.
PubMed 22071711
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Palm Olein Versus Olive Oil on Blood Lipids, Lipoproteins and Novel Risk Markers of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00743301
- Acronym / sponsor ID
- A305 / HB2008-056
- Conditions
- Cardiovascular Disease, Metabolic Syndrome
- Keywords
- CVD, Palm olein, Olive oil, Lard, healthy men, metabolic syndrome, Risk of cardiovascular disease and metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olive oil | Active comparator | Other: Palm olein vs olive oil and lard |
| Palm olein | Experimental | Other: Palm olein vs olive oil and lard |
| Lard | Active comparator | Other: Palm olein vs olive oil and lard |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All participants must give their informed consent in writing, after having received oral and written information about the study
- Age: 18-65 y
- BMI: 18.5 - 30 mg/m2
- Men
- Healthy (no known diseases, incl. hypertension, hypercholesterolemia, diabetes and psoriasis)
Key exclusion criteria (7 listed)
- Current or previously cardiovascular disease
- Diabetes Mellitus or other severe chronic disease, including severe allergies and psoriasis
- Hypertension
- Known or suspected abuse of alcohol, drugs or medication
- Own request: all participants have the right to withdraw from the intervention at any given time without explanation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palm olein vs olive oil and lard17E% from test fat is incorporated into three rolls and a piece of cake | Other | Lard, Olive oil, Palm olein |
Primary outcome
total, HDL, LDL cholesterol and triacylglycerol
Time frame: before and after each type of dietary fat
1 secondary outcome
fasting insulin and glucose, c reactive protein and plasminogen activator inhibitor 1
Time frame: befoer and after each dietary test fat
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2008.
- Derived from this study: PubMed 22071711Tholstrup 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tine Tholstrup, PhD principal investigator
Department of Human Nutrition, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palm olein vs olive oil and lard in people with Cardiovascular Disease and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marianne Raff, PhD (+4535332533, mrf@life.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total, HDL, LDL cholesterol and triacylglycerol (time frame: before and after each type of dietary fat). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00743301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2008.