Cardiovascular Risk FactorMC1NCT02802904
Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers
A study testing Diet: Palm olein IV64, Diet: Cocoa butter and Diet: Virgin olive oil in people with Cardiovascular Risk Factor, run by Malaysia Palm Oil Board.
Trial summary
Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Diet: Palm olein IV64, Diet: Cocoa butter and Diet: Virgin olive oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male or female, aged 20-50 years
- BMI 18.5- 24.9 kg/m2 as per WHO Classification (1998)
Who cannot join
- Hyperlipidemia (TC>6.2 mmol/L, TAG >2.0 mmol/L)
- History of chronic disease- type 2 DM, heart disease, cancer
- Habitual smokers (>2 sticks a day)
- Hypertensives: >140/90 mmHg
- On medication/nutraceuticals to reduce blood lipids, blood pressure
- Pregnant or lactating women
- Planned trip abroad/overseas during period of study
About this study
Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the "sn-2 hypothesis". New evidence have also emerged to show that saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. In this proposed study, the effects on the outcome measures investigated of three test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)], with oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated
Read the detailed description
To investigate the effects of different dietary fats with primarily oleic acid in the sn-2 position on the cardiovascular risk profile in healthy Malaysian volunteers
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Diet: Palm olein IV64, Diet: Cocoa butter, Diet: Virgin olive oil
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet: Palm olein IV64Other
Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
Diet: Cocoa butterOther
Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
Diet: Virgin olive oilOther
Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
| Study group | Role | What they receive |
|---|---|---|
| Palm olein IV 64 | Experimental | Palm olein IV 64, n= 15, 4 weeks intervention Receives: Other: Diet: Palm olein IV64 |
| Cocoa butter | Experimental | Cocoa butter, n= 15, 4 weeks intervention Receives: Other: Diet: Cocoa butter |
| Virgin olive oil | Experimental | Virgin olive oil, n= 15, 4 weeks intervention Receives: Other: Diet: Virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline) and week 4
Secondary outcomes (9)
changes of serum HDL cholesterol
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline) and week 4
changes of serum LDL cholesterol
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline) and week 4
changes of serum Triacylglycerol (TAG)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline) and week 4
changes of serum non-esterified fatty acids (NEFA)
analysed by ELISA kits
Measured: week 0 (baseline) and week 4
changes of serum LDL sub-fractions
analysed with LIPOPRINT System
Measured: week 0 (baseline) and week 4
changes of serum Lp(a)
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
Measured: week 0 (baseline) and week 4
changes of Blood pressure
measured by blood pressure meter
Measured: week 0 (baseline) and week 4
Changes of body mass index (BMI)
measured by Tanita Segmental Body Fat Analysis
Measured: week 0 (baseline) and week 4
changes of Waist circumference
Measured: week 0 (baseline) and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- IMU University, Malaysia
- Responsible party
- Sponsor
- Investigators
- Datuk Dr. Choo Yuen May, PhD, Study chair, MPOBEmeritus Prof. Datuk Dr. Augustine Ong Soon Hock, PhD, Study chair, Malaysian Oil Scientists and Technologists' Association (MOSTA)Assoc Prof Dr Tony Ng Kock Wai, PhD, Principal investigator, IMUDr Kanga Rani Selvaduray, PhD, Principal investigator, MPOBRadhika Loganathan, MSc, Principal investigator, MPOBDr Darren Gouk Siew Wah, PhD, Principal investigator, MPOBGowri Nagapan, MSc, Principal investigator, MPOB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802904
- Sponsor's protocol ID
- PD205/15- STUDY 1 (A)
- Acronym
- MC1
- Status last verified
- Jun 2016
- First submitted
- 2 Jun 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicountry Studies on the Effect of Positional Distribution of Fatty Acids at Triglyceride Backbone on Serum Lipids, Lipoprotein(a) and LDL-subclasses in Healthy Malaysian Volunteers
- ClinicalTrials.gov ID
- NCT02802904
- Acronym / sponsor ID
- MC1 / PD205/15- STUDY 1 (A)
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Healthy subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- IMU University, Malaysia
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Jun 2016 (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.
Fats and oils are made up of >90% triacylglycerol fat molecules which consist of a glycerol backbone to which 3 esterified fatty acids are attached. The positions of fatty acid attachment are referred to by stereospecific numbers, sn -1, -2 and -3. There is existing evidence to show that vegetable oils having unsaturated fatty acids in the sn-2 position with predominantly palmitic acid (16:0) or stearic acid (18:0) in the sn-1 and sn-3 positions of fat molecules do not raise serum cholesterol levels. These observations have come to be known as or explained by the "sn-2 hypothesis". New evidence have also emerged to show that saturated fatty acids (16:0, 18:0) in the sn-1 and -3 positions reduces fat deposition in a rat model. In this proposed study, the effects on the outcome measures investigated of three test fats [namely palm olein IV64 (POP), virgin olive oil (OOO) and cocoa butter (POS)], with oleic acid primarily at the sn-2 position but differing amounts of palmitic, stearic and oleic acids at the sn-1/sn-3 positions of the triglyceride molecule, are investigated
Detailed description
To investigate the effects of different dietary fats with primarily oleic acid in the sn-2 position on the cardiovascular risk profile in healthy Malaysian volunteers
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palm olein IV 64 | Experimental | Other: Diet: Palm olein IV64Palm olein IV 64, n= 15, 4 weeks intervention |
| Cocoa butter | Experimental | Other: Diet: Cocoa butterCocoa butter, n= 15, 4 weeks intervention |
| Virgin olive oil | Experimental | Other: Diet: Virgin olive oilVirgin olive oil, n= 15, 4 weeks intervention |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult male or female, aged 20-50 years
- BMI 18.5- 24.9 kg/m2 as per WHO Classification (1998)
Key exclusion criteria (7 listed)
- Hyperlipidemia (TC>6.2 mmol/L, TAG >2.0 mmol/L)
- History of chronic disease- type 2 DM, heart disease, cancer
- Habitual smokers (>2 sticks a day)
- Hypertensives: >140/90 mmHg
- On medication/nutraceuticals to reduce blood lipids, blood pressure
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 |
|---|---|---|
| Diet: Palm olein IV64Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily. | Other | Palm olein IV 64 |
| Diet: Cocoa butterEach subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily. | Other | Cocoa butter |
| Diet: Virgin olive oilEach subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily. | Other | Virgin olive oil |
Primary outcome
Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL)
Time frame: week 0 (baseline) and week 4
analyzed enzymatically by Siemens Advia 2400 Chemistry Analyzer
9 secondary outcomes
changes of serum HDL cholesterol
Time frame: week 0 (baseline) and week 4
changes of serum LDL cholesterol
Time frame: week 0 (baseline) and week 4
changes of serum Triacylglycerol (TAG)
Time frame: week 0 (baseline) and week 4
changes of serum non-esterified fatty acids (NEFA)
Time frame: week 0 (baseline) and week 4
changes of serum LDL sub-fractions
Time frame: week 0 (baseline) and week 4
changes of serum Lp(a)
Time frame: week 0 (baseline) and week 4
changes of Blood pressure
Time frame: week 0 (baseline) and week 4
Changes of body mass index (BMI)
Time frame: week 0 (baseline) and week 4
changes of Waist circumference
Time frame: week 0 (baseline) and week 4
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 17 Jun 2016.
- Individual participant dataSharing planned: Undecided
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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.
Datuk Dr. Choo Yuen May, PhD study chair
MPOB
Emeritus Prof. Datuk Dr. Augustine Ong Soon Hock, PhD study chair
Malaysian Oil Scientists and Technologists' Association (MOSTA)
Assoc Prof Dr Tony Ng Kock Wai, PhD principal investigator
IMU
Questions about this trial
What is this clinical trial studying?
A study testing Diet: Palm olein IV64, Diet: Cocoa butter and Diet: Virgin olive oil in people with Cardiovascular Risk Factor, run by Malaysia Palm Oil Board.
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 2 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: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes of Ratio of total cholesterol to HDL cholesterol (TC:HDL) (time frame: week 0 (baseline) and week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2016.