OverweightNCT02245113
Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian
A study testing diets in people with Overweight, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
This study will be comparing human body responses by the effects of diets cooked with NoveLin, virgin olive oil and RBD coconut oil. 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?
- diets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2013to Jul 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
- males and females aged 20-60 years
- BMI 23 - 27.5 kg/m2
- free from any disease
- not on any medication or treatment associated with reduction of CVD
- non-smokers and non-heavy drinker or having smoking or alcoholic history
- not pregnant or lactating
- willing and able to comply
Who cannot join
- people on weight reduction therapy/program
- people on cholesterol reduction medicatio
- have one or more of the chronic diseases
- people with blood clotting problem/ coagulopathy / deep vein thrombosis.
- hypertensive persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg)
- female who is pregnant
- people travel to overseas during feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of High Oleic Palm Olein (HOPO), Virgin Olive Oil (OO) and Refined Bleached and Deodorized (RBD) Coconut Oil (CO) Diets on Lipid Profile, Markers of Insulin Resistance, Inflammatory and Obesity in Overweight Subject.
This study will be comparing human body responses by the effects of diets cooked with NoveLin, virgin olive oil and RBD coconut oil.
Read the detailed description
NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive oil. Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83% oleic acid. Consumption of olive oil gives numerous health benefits on lowering total and LDL cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood pressure. Coconut oil is the richest source of medium chain fatty acid and it has greater than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0). RBD coconut oil is used as positive control in this study.
- Conditions
- Overweight
- Being tested
- diets
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietsOther
Feeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Test Fat P | Experimental | Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3. Receives: Other: diets |
| Test Fat Q | Experimental | Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3. Receives: Other: diets |
| Test Fat R | Experimental | Test fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3. Receives: Other: diets |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in c-peptide level
Measured: week 0(baseline) and week 6
Secondary outcomes (5)
change in insulin resistance's markers
Measured: week 0(baseline) and week 6
change in inflammatory markers
Measured: week 0(baseline) and week 6
change in obesity markers
Measured: week 0(baseline) and week 6
change in lipid profile
Measured: week 0(baseline) and week 6
change in physical characteristic (eg. BMI, body weight)
Measured: week 0(baseline) and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Collaborators
- Universiti Putra Malaysia, IMU University, Malaysia
- Responsible party
- Sponsor
- Investigators
- Voon Phooi Tee, PhD, Principal investigator, MPOBLee Sin Tien, BSc, Principal investigator, UPMNorhaizan Md Esa, PhD, Principal investigator, UPMTony Ng Kock Wai, PhD, Principal investigator, IMUVerna Lee Kar Mun, PhD, Principal investigator, IMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245113
- Sponsor's protocol ID
- R002302000
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Oleic Palm Olein (HOPO), Virgin Olive Oil (OO) and Refined Bleached and Deodorized (RBD) Coconut Oil (CO) Diets on Lipid Profile, Markers of Insulin Resistance, Inflammatory and Obesity in Overweight Subject.
- ClinicalTrials.gov ID
- NCT02245113
- Acronym / sponsor ID
- R002302000
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Collaborators
- Universiti Putra Malaysia, IMU University, Malaysia
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 19 Sep 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.
This study will be comparing human body responses by the effects of diets cooked with NoveLin, virgin olive oil and RBD coconut oil.
Detailed description
NoveLin has high content of monounsaturate fatty acids - oleic acid (C18:1) which is the predominant fatty acid and in this study NoveLin is used as cooking fat in compare with olive oil. Olive oil is the world's most commonly eaten monounsaturated oil which contains 55 - 83% oleic acid. Consumption of olive oil gives numerous health benefits on lowering total and LDL cholesterol, reducing LDL cholesterol's, lowering blood clotting factors, and lowering blood pressure. Coconut oil is the richest source of medium chain fatty acid and it has greater than 90% of saturated fatty acid with dominant fatty acid of lauric acid (C12:0). RBD coconut oil is used as positive control in this study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test Fat P | Experimental | Other: dietsTest fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3. |
| Test Fat Q | Experimental | Other: dietsTest fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3. |
| Test Fat R | Experimental | Other: dietsTest fat, n= 10 (minimum), 6 weeks intervention, Intervention 1, Intervention 2, and Intervention 3. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- males and females aged 20-60 years
- BMI 23 - 27.5 kg/m2
- free from any disease
- not on any medication or treatment associated with reduction of CVD
- non-smokers and non-heavy drinker or having smoking or alcoholic history
Key exclusion criteria (7 listed)
- people on weight reduction therapy/program
- people on cholesterol reduction medicatio
- have one or more of the chronic diseases
- people with blood clotting problem/ coagulopathy / deep vein thrombosis.
- 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 |
|---|---|---|
| dietsFeeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared. | Other | Test Fat P, Test Fat Q, Test Fat R |
Primary outcome
change in c-peptide level
Time frame: week 0(baseline) and week 6
5 secondary outcomes
change in insulin resistance's markers
Time frame: week 0(baseline) and week 6
change in inflammatory markers
Time frame: week 0(baseline) and week 6
change in obesity markers
Time frame: week 0(baseline) and week 6
change in lipid profile
Time frame: week 0(baseline) and week 6
change in physical characteristic (eg. BMI, body weight)
Time frame: week 0(baseline) and week 6
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 19 Sep 2014.
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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 Phooi Tee, PhD principal investigator
MPOB
Lee Sin Tien, BSc principal investigator
UPM
Norhaizan Md Esa, PhD principal investigator
UPM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diets 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 7 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 19 Sep 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 c-peptide level (time frame: week 0(baseline) and week 6). 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 19 Sep 2014.