HealthyNCT04156503
Pilot Study-Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
A study testing Palm olein vs Lard in people with Healthy, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
13C NMR spectroscopy has been validated to be a rapid, direct and accurate quantitative method in determination of positional distribution of fatty acids in edible oils and fats, including the palm oil fractions (from soft olein to hard stearin). Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Palm olein vs Lard
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteMalaysia
- Study dates
- 18 Oct 2019to 31 Dec 2020
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non muslim, aged between 25 - 40 yrs old.
- BMI between 20 - 27.5 kg/m2.
- Blood pressure with <130mmHg for systolic pressure and < 80 mmHg for diastolic pressure.
- Blood glucose level in the range of 3.9 to 5.5 mmol/L.
- Total cholesterol level < 6.0 mmol/L.
- Triglycerides level < 2.3 mmol/L.
- No use of tobacco and no consumption of alcohol.
Who cannot join
- Suffer from chronic disease such as CVD, hypertension, diabetic, metabolic syndrome.
- Consuming any medical prescriptions/ supplements.
- Having blood clotting problem.
- Women who are pregnant or lactating.
- Hypertensive condition with systolic pressure >140mmHg and diastolic pressure > 90 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for the Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
13C NMR spectroscopy has been validated to be a rapid, direct and accurate quantitative method in determination of positional distribution of fatty acids in edible oils and fats, including the palm oil fractions (from soft olein to hard stearin). Nevertheless, there is paucity of literature describing its application in determining the positional fatty acid composition in blood triacylglycerols \& biological samples, despite its widely used application in edible oils and fats. The postprandial feeding intervention is aimed to harvest chylomicron rich in triglycerides (~97% TAG) for NMR analysis.
Read the detailed description
A pilot postprandial study with double blind, 2x2 arms randomized crossover experimental design will be carried out. A total of 10 subjects (5 males, 5 females) will be recruited and divided into 2 groups. Each group will be assigned to one of the test fat and fed with test meal prepared with 50g of test fats. 10 mL of blood samples will be collected at time points 0 (baseline, before meal) and 3, 4 and 5h after finish the meal. There shall be a 2-weeks washout period between each test fat.
Test fats used for this study are palm olein, with predominantly oleic acid at sn-2 position of the triglyceride backbone (about 68%, Gunstone et al, 2007) and lard, with predominantly palmitic acid at sn-2 position (about 72%, Gunstone et al., 2007). A high fat muffin with 50g of test fat will be formulated using the above two test fats mentioned. On each study day, a high fat muffin will be served and a glass of skim milk will be provided for subjects to help the digestion of fats from the muffins.
Chylomicron will be harvested using the ultracentrifugation technique. Samples collected will be stored in -80°C prior to NMR analysis.
- Conditions
- Healthy
- Being tested
- Palm olein vs Lard
- Keywords
- Chylomicron, fatty acid composition, lard, palm olein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm olein vs LardOther
A 5-hour postprandial feeding intervention with 2-weeks washout in between. Blood samples will be collected at hour 0 (baseline) before test meal, and hour 3, 4 and 5 after consumption of test meal.
| Study group | Role | What they receive |
|---|---|---|
| Test fat: Palm olein | Experimental | One high fat muffin will be serves together with a glass of low fat milk shake. Receives: Other: Palm olein vs Lard |
| Test fat: Lard | Experimental | One high fat muffin will be serves together with a glass of low fat milk shake. Receives: Other: Palm olein vs Lard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides profile in chylomicron harvested
the positional composition of fatty acid in test fat that are retained upon absorption ( samples are pooled from 3, 4 \&5 hour after test diet)
Measured: Up to hour 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start18 Oct 2019
- Primary completion30 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Phooi Tee Voon, Ph.D, Principal investigator, MPOB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156503
- Sponsor's protocol ID
- PD222/17
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2019
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
- ClinicalTrials.gov ID
- NCT04156503
- Acronym / sponsor ID
- PD222/17
- Conditions
- Healthy
- Keywords
- Chylomicron, fatty acid composition, lard, palm olein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- 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.
13C NMR spectroscopy has been validated to be a rapid, direct and accurate quantitative method in determination of positional distribution of fatty acids in edible oils and fats, including the palm oil fractions (from soft olein to hard stearin). Nevertheless, there is paucity of literature describing its application in determining the positional fatty acid composition in blood triacylglycerols \& biological samples, despite its widely used application in edible oils and fats. The postprandial feeding intervention is aimed to harvest chylomicron rich in triglycerides (~97% TAG) for NMR analysis.
Detailed description
A pilot postprandial study with double blind, 2x2 arms randomized crossover experimental design will be carried out. A total of 10 subjects (5 males, 5 females) will be recruited and divided into 2 groups. Each group will be assigned to one of the test fat and fed with test meal prepared with 50g of test fats. 10 mL of blood samples will be collected at time points 0 (baseline, before meal) and 3, 4 and 5h after finish the meal. There shall be a 2-weeks washout period between each test fat.
Test fats used for this study are palm olein, with predominantly oleic acid at sn-2 position of the triglyceride backbone (about 68%, Gunstone et al, 2007) and lard, with predominantly palmitic acid at sn-2 position (about 72%, Gunstone et al., 2007). A high fat muffin with 50g of test fat will be formulated using the above two test fats mentioned. On each study day, a high fat muffin will be served and a glass of skim milk will be provided for subjects to help the digestion of fats from the muffins.
Chylomicron will be harvested using the ultracentrifugation technique. Samples collected will be stored in -80°C prior to NMR analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test fat: Palm olein | Experimental | Other: Palm olein vs LardOne high fat muffin will be serves together with a glass of low fat milk shake. |
| Test fat: Lard | Experimental | Other: Palm olein vs LardOne high fat muffin will be serves together with a glass of low fat milk shake. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Non muslim, aged between 25 - 40 yrs old.
- BMI between 20 - 27.5 kg/m2.
- Blood pressure with <130mmHg for systolic pressure and < 80 mmHg for diastolic pressure.
- Blood glucose level in the range of 3.9 to 5.5 mmol/L.
- Total cholesterol level < 6.0 mmol/L.
Key exclusion criteria (5 listed)
- Suffer from chronic disease such as CVD, hypertension, diabetic, metabolic syndrome.
- Consuming any medical prescriptions/ supplements.
- Having blood clotting problem.
- Women who are pregnant or lactating.
- Hypertensive condition with systolic pressure >140mmHg and 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 |
|---|---|---|
| Palm olein vs LardA 5-hour postprandial feeding intervention with 2-weeks washout in between. Blood samples will be collected at hour 0 (baseline) before test meal, and hour 3, 4 and 5 after consumption of test meal. | Other | Test fat: Lard, Test fat: Palm olein |
Primary outcome
Triglycerides profile in chylomicron harvested
Time frame: Up to hour 5
the positional composition of fatty acid in test fat that are retained upon absorption ( samples are pooled from 3, 4 \&5 hour after test diet)
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 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Phooi Tee Voon, Ph.D principal investigator
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 Palm olein vs Lard 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 7 inclusion and 5 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 27 Feb 2026. 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?
Triglycerides profile in chylomicron harvested (time frame: Up to hour 5). 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 27 Feb 2026.