OverweightNCT02192047
Chronic Effects of Natural and Interesterified Fats Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
A study testing Palm Olein, IE Palm olein and IE soybean oil-based in people with Overweight, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Palm Olein, IE Palm olein and IE soybean oil-based
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteMalaysia
- Study dates
- Sep 2012to Mar 2014
- 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
- Adult males and females, aged 20-60 yr
- Staff and students of International Medical University, IMU/ Staff of Malaysian Palm Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks
- BMI 21 - 30 kg/m2
Who cannot join
- Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT; aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma creatinine)
- History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism
- Smokers
- On lipid/blood pressure- lowering medication/supplements
- Blood pressure>140/90 mmHg
- Fasting total cholesterol > 6.5 mmol/L
- Fasting TAG > 2.0 mmol/L
- Candidates who are going abroad during the planned schedule for the dietary intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.
Read the detailed description
Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according to parallel designed sequences. The test fats used for this study are palm oil, chemically interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary guidelines throughout the study. Blood collection sessions will held before and after every diet intervention. Outcome measures of the study are serum lipid profile, markers of inflammation, markers of obesity and insulin resistance.
- Conditions
- Overweight
- Being tested
- Palm Olein, IE Palm olein, IE soybean oil-based
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm OleinOther
8 weeks
IE Palm oleinOther
8 weeks
IE soybean oil-basedOther
8 weeks
| Study group | Role | What they receive |
|---|---|---|
| palm olein margarine | Experimental | 8 weeks Receives: Other: Palm Olein |
| IE palm olein margarine | Experimental | 8 weeks Receives: Other: IE Palm olein |
| IE soybean oil-based margarine | Experimental | 8 weeks Receives: Other: IE soybean oil-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum C-peptide level of subject
Measured: up to 8 weeks
Secondary outcomes (5)
Change in serum lipid profile
Measured: up to 8 weeks
Change in markers of inflammation
Measured: up to 8 weeks
Change in markers of obesity
Measured: up to 8 weeks
Change in markers of insulin resistance
Measured: up to 8 weeks
Oral Glucose tolerance test (OGTT)
Measured: Baseline, month-2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
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 OverweightStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- IMU University, Malaysia, Universiti Putra Malaysia
- Responsible party
- Sponsor
- Investigators
- Voon Phooi Tee, Ph.D, Principal investigator, MPOBNg Yen Teng, BSc, Principal investigator, IMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192047
- Sponsor's protocol ID
- PD 174/13
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ng YT, Voon PT, Ng TKW, Lee VKM, Mat Sahri M, Mohd Esa N. Interesterified fats rich in palmitic and stearic acids have comparable effects on selected inflammatory related biomarkers. Eur J Nutr. 2026 Jul 3;65(5):195. doi: 10.1007/s00394-026-04048-x.
PubMed 42397442
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
- ClinicalTrials.gov ID
- NCT02192047
- Acronym / sponsor ID
- PD 174/13
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- IMU University, Malaysia, Universiti Putra Malaysia
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 16 Jul 2014 (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 investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.
Detailed description
Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according to parallel designed sequences. The test fats used for this study are palm oil, chemically interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary guidelines throughout the study. Blood collection sessions will held before and after every diet intervention. Outcome measures of the study are serum lipid profile, markers of inflammation, markers of obesity and insulin resistance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| palm olein margarine | Experimental | Other: Palm Olein8 weeks |
| IE palm olein margarine | Experimental | Other: IE Palm olein8 weeks |
| IE soybean oil-based margarine | Experimental | Other: IE soybean oil-based8 weeks |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult males and females, aged 20-60 yr
- Staff and students of International Medical University, IMU/ Staff of Malaysian Palm Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks
- BMI 21 - 30 kg/m2
Key exclusion criteria (8 listed)
- Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT; aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma creatinine)
- History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism
- Smokers
- On lipid/blood pressure- lowering medication/supplements
- Blood pressure>140/90 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 Olein8 weeks | Other | palm olein margarine |
| IE Palm olein8 weeks | Other | IE palm olein margarine |
| IE soybean oil-based8 weeks | Other | IE soybean oil-based margarine |
Primary outcome
Change in serum C-peptide level of subject
Time frame: up to 8 weeks
5 secondary outcomes
Change in serum lipid profile
Time frame: up to 8 weeks
Change in markers of inflammation
Time frame: up to 8 weeks
Change in markers of obesity
Time frame: up to 8 weeks
Change in markers of insulin resistance
Time frame: up to 8 weeks
Oral Glucose tolerance test (OGTT)
Time frame: Baseline, month-2
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 16 Jul 2014.
- Derived from this study: PubMed 42397442Ng YT, Voon PT, Ng TKW, Lee VKM, Mat Sahri M, Mohd Esa N. Interesterified fats rich in palmitic and stearic acids have comparable effects on selected inflammatory related biomarkers. Eur J Nutr. 2026 Jul 3;65(5):195. doi: 10.1007/s00394-026-04048-x.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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 Phooi Tee, Ph.D principal investigator
MPOB
Ng Yen Teng, BSc principal investigator
IMU
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, IE Palm olein and IE soybean oil-based in people with Overweight, 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 3 inclusion and 8 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 16 Jul 2014. 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?
Change in serum C-peptide level of subject (time frame: up to 8 weeks). 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 NCT02192047, 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 16 Jul 2014.