HealthyNCT00941837
Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels
A study testing Olive Oil, Palm Olein Oil, Coconut Oil in people with Healthy, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
In this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common Malaysian foods. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olive Oil, Palm Olein Oil, Coconut Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMalaysia
- Study dates
- Feb 2009to Oct 2010
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy adult males and females aged 20-60 years, with BMI 23.0 -29.9 kg/m2, and free from any disease (will be decided through history taking, physical examination and biochemical tests).
- Not on any medication or treatment associated with reduction of CHD.
- Non-smokers and non heavy drinker or having smoking or alcoholic history.
- Not pregnant or lactating.
- Willing to adhere to the Dietary Guidelines to the study.
Who cannot join
- Obese [Body Mass Index (BMI) ≥ 30] or grossly underweight (BMI < 18).
- Suffering from chronic diseases such as diabetes mellitus, CHD, cancer or any liver/renal disease.
- People with blood clotting problem.
- Hypertensive persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels and Selected Markers of Cardiovascular Heart Disease Risk in Human Volunteers
In this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common Malaysian foods.
Hypothesis: There is a significant difference on the effects of the three experimental oils (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary heart disease (CHD) risk measured.
Read the detailed description
The experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate. Each of the test fat [palm olein (POo), virgin olive oil (OO) and coconut oil (CO)] contributes to two-thirds of total dietary fat will be compared.
Three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided for the 5-weeks period of each fat rotation.
45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. They were then stratified into 3 groups according to gender, homocysteine and cholesterol level. The volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention. Each intervention will take 5 wk with 2 wk wash out in between.
Baseline blood samples will be taken while other blood samples will be collected at week-4 and -5 of the study.
- Conditions
- Healthy
- Being tested
- Olive Oil, Palm Olein Oil, Coconut Oil
- Keywords
- Palm olein, homocsyteine, Cholesterol, lipoproteins, Interleukins, CRP, Blood Pressure, Total homocystein, Serum lipid profile, Serum apolipoproteins, Inflammatory markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive Oil, Palm Olein Oil, Coconut OilDietary supplement
Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between
| Study group | Role | What they receive |
|---|---|---|
| Olive Oil | Experimental | Not described Receives: Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil |
| Coconut oil | Experimental | Not described Receives: Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil |
| Palm Olein | Experimental | Not described Receives: Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total homocysteine
Measured: 4th and 5th week
Secondary outcomes (1)
Lipids profile and inflammatory markers
Measured: 4th and 5th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- International Medical University (IMU), Kuala Lumpur,Malaysia
- Investigators
- Voon P T, Principal investigator, IMU/MPOB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941837
- Sponsor's protocol ID
- IMU R043/2008
- Status last verified
- Jun 2011
- First submitted
- 16 Jul 2009
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Voon PT, Ng TK, Lee VK, Nesaretnam K. Virgin olive oil, palm olein and coconut oil diets do not raise cell adhesion molecules and thrombogenicity indices in healthy Malaysian adults. Eur J Clin Nutr. 2015 Jun;69(6):712-6. doi: 10.1038/ejcn.2015.26. Epub 2015 Mar 25.
PubMed 25804278Voon PT, Ng TK, Lee VK, Nesaretnam K. Diets high in palmitic acid (16:0), lauric and myristic acids (12:0 + 14:0), or oleic acid (18:1) do not alter postprandial or fasting plasma homocysteine and inflammatory markers in healthy Malaysian adults. Am J Clin Nutr. 2011 Dec;94(6):1451-7. doi: 10.3945/ajcn.111.020107. Epub 2011 Oct 26.
PubMed 22030224
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels and Selected Markers of Cardiovascular Heart Disease Risk in Human Volunteers
- ClinicalTrials.gov ID
- NCT00941837
- Acronym / sponsor ID
- IMU R043/2008
- Conditions
- Healthy
- Keywords
- Palm olein, homocsyteine, Cholesterol, lipoproteins, Interleukins, CRP, Blood Pressure, Total homocystein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- International Medical University (IMU), Kuala Lumpur,Malaysia
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 20 Jul 2009 (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.
In this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common Malaysian foods.
Hypothesis: There is a significant difference on the effects of the three experimental oils (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary heart disease (CHD) risk measured.
Detailed description
The experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate. Each of the test fat [palm olein (POo), virgin olive oil (OO) and coconut oil (CO)] contributes to two-thirds of total dietary fat will be compared.
Three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided for the 5-weeks period of each fat rotation.
45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. They were then stratified into 3 groups according to gender, homocysteine and cholesterol level. The volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention. Each intervention will take 5 wk with 2 wk wash out in between.
Baseline blood samples will be taken while other blood samples will be collected at week-4 and -5 of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olive Oil | Experimental | Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil |
| Coconut oil | Experimental | Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil |
| Palm Olein | Experimental | Dietary Supplement: Olive Oil, Palm Olein Oil, Coconut Oil |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Apparently healthy adult males and females aged 20-60 years, with BMI 23.0 -29.9 kg/m2, and free from any disease (will be decided through history taking, physical examination and biochemical tests).
- Not on any medication or treatment associated with reduction of CHD.
- Non-smokers and non heavy drinker or having smoking or alcoholic history.
- Not pregnant or lactating.
- Willing to adhere to the Dietary Guidelines to the study.
Key exclusion criteria (4 listed)
- Obese [Body Mass Index (BMI) ≥ 30] or grossly underweight (BMI < 18).
- Suffering from chronic diseases such as diabetes mellitus, CHD, cancer or any liver/renal disease.
- People with blood clotting problem.
- Hypertensive persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg)
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 |
|---|---|---|
| Olive Oil, Palm Olein Oil, Coconut OilEffect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between | Dietary supplement | Coconut oil, Olive Oil, Palm Olein |
Primary outcome
Total homocysteine
Time frame: 4th and 5th week
1 secondary outcome
Lipids profile and inflammatory markers
Time frame: 4th and 5th weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 25804278Voon PT, Ng TK, Lee VK, Nesaretnam K. Virgin olive oil, palm olein and coconut oil diets do not raise cell adhesion molecules and thrombogenicity indices in healthy Malaysian adults. Eur J Clin Nutr. 2015 Jun;69(6):712-6. doi: 10.1038/ejcn.2015.26. Epub 2015 Mar 25.
- Derived from this study: PubMed 22030224Voon PT, Ng TK, Lee VK, Nesaretnam K. Diets high in palmitic acid (16:0), lauric and myristic acids (12:0 + 14:0), or oleic acid (18:1) do not alter postprandial or fasting plasma homocysteine and inflammatory markers in healthy Malaysian adults. Am J Clin Nutr. 2011 Dec;94(6):1451-7. doi: 10.3945/ajcn.111.020107. Epub 2011 Oct 26.
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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.
Voon P T principal investigator
IMU/MPOB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive Oil, Palm Olein Oil, Coconut Oil in people with Healthy, run by Malaysia Palm Oil Board at 1 site in Malaysia.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2011. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total homocysteine (time frame: 4th and 5th week). 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 NCT00941837, which also lists 2 linked publications.
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 8 Jun 2011.