Cardiovascular Risk FactorNCT02263183
Red Palm Olein and Cardiovascular Health
A study testing Red Palm Olein and Palm Olein in people with Cardiovascular Risk Factor, run by Malaysia Palm Oil Board at 1 site in Malaysia.
Trial summary
Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing to this special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Red Palm Olein and Palm Olein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteMalaysia
- Study dates
- Jan 2013to Dec 2017
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female), age between 20-60 years and BMI ≥18.5kgm2 will be recruited.
Who cannot join
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes
- Blood glucose; >7.0 mmol/L
- Serum triacylglycerol; >4.5 mmol/L
- Serum total cholesterol; >6.5 mmol/L
- Body mass index <18.5 kg/m2
- Current use of antihypertensive or lipid lowering medication
Show all 10Show fewer
- Alcohol intake exceeding a moderate intake (>28 units per week)
- Breastfeeding or pregnant
- Consume supplement such as herbs and hormone pills
- Smoking
Trial locations and contacts
1 site in 1 country.
About this study
Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing to this special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents through which palm oil exhibits its nutritional properties. Among the major health promoting properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition, brain development and neuro-protective properties, antioxidative defence mechanisms, provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and health benefits, the potential of improved cardiovascular health should be considered to understand better and thus treasure more our golden oil.
Read the detailed description
The oil palm Elaeis guineesis, is the source of palm oil - the 'tropical golden oil'. Malaysia is the world's largest exporter of this golden oil. Triglycerides constitute the major component of crude palm oil, with smaller proportions of diglycerides and monoglycerides. The oil also contains other minor constituents, such as free fatty acids and phytonutrients. This composition determines the oil's physical, chemical and physiological characteristics. In food application, palm oil not only imparts functional properties as a heating medium (as in frying of foods) and in having spreadability (as in formulations for solid fat products like margarines and shortenings), but is also a good source of phytonutrients. Although the phytonutrients constitute only about 1% of its weight in crude palm oil, these are the main constituents through which palm oil exhibits its nutritional properties. Among the major health promoting properties shown to be associated with the various types of phytonutrients present in palm oil are anti-cancer, cardio-protection and anti-angiogenesis, cholesterol inhibition, brain development and neuro-protective properties, antioxidative defence mechanisms, provitamin A activity and anti-diabetes. Red palm oil (RPO) is obtained from crude palm oil through a novel low-temperature process. Owing to this special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients that include carotenes (thus giving the oil a bright red colour), vitamin E, phytosterols, phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10.
Little is known about the physiological effects of red palm oil. The link between dietary fats and cardiovascular diseases has always been controversial in the context of palm oil. Narang et al., 2004 demonstrated that the anti-oxidant vitamins in palm olein play a vital role in the protection of the rat's heart against oxidative stress induced by ischemic-reperfusion injury. The unique isomeric position of its fatty acids and the presence of tocotrienols cause the endogenous cholesterol level to drop. Besides palm oil could reduce the risk of arterial thrombosis and atherosclerosis, inhibit endogenous cholesterol biosynthesis, platelet aggregation, and reduce blood pressure. The composition of palm oil with an unsaturated-to-saturated fatty acid ratio close to one and rich in antioxidants vitamins could attenuate the progression of salt-induced hypertension and mortality in rats by modulation of endothelial function and reduction in oxidative stress. In Chinese diet preparation, Zhang et al.,2003 demonstrated that red palm oil is a good source of carotenoids and vitamin E, and it could significantly increase plasma concentration of alpha-carotene, beta-carotene, lycopene and alpha-tocopherol. Following a chronic human study, Scholtz et al., 2004 observed that red palm olein had less detrimental effects on the lipid profile and decreased tissue plasminogen activator antigen as compared to palm olein. As red palm oil has variety of phytonutrients and health benefits, the potential of improved cardiovascular health should be considered to understand better and thus treasure more our golden oil. The present study was designed to investigate the effect of consumption of red palm olein on inflammatory and metabolic risk markers
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Red Palm Olein, Palm Olein
- Keywords
- Metabolic risk, Abdominally overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Palm OleinDietary supplement
Also called Carotino
Red Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E)
Palm OleinDietary supplement
Also called Carotino
Palm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E)
| Study group | Role | What they receive |
|---|---|---|
| red palm olein(labelled A) | Active comparator | red palm olein (labelled A) Receives: Dietary Supplement: Red Palm Olein |
| palm olein(labelled B)(control) | Placebo comparator | palm olein(labelled B)(control) Receives: Dietary Supplement: Palm Olein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma Interleukin-6 status
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malaysia Palm Oil Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Radhika Loganathan, Masters, Principal investigator, Malaysia Palm Oil Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263183
- Sponsor's protocol ID
- PD164/12
- Status last verified
- Sep 2016
- First submitted
- 22 Sep 2014
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bayorh MA, Abukhalaf IK, Ganafa AA. Effect of palm oil on blood pressure, endothelial function and oxidative stress. Asia Pac J Clin Nutr. 2005;14(4):325-39.
PubMed 16326639Choo YM, Ng MH, Ma AN, Chuah CH, Hashim MA. Application of supercritical fluid chromatography in the quantitative analysis of minor components (carotenes, vitamin E, sterols, and squalene) from palm oil. Lipids. 2005 Apr;40(4):429-32. doi: 10.1007/s11745-006-1400-6.
PubMed 16028723Edem DO. Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. Plant Foods Hum Nutr. 2002 Fall;57(3-4):319-41. doi: 10.1023/a:1021828132707.
PubMed 12602939Loganathan R Jr, Selvaduray KR, Nesaretnam K, Radhakrishnan AK. Health promoting effects of phytonutrients found in palm oil. Malays J Nutr. 2010 Aug;16(2):309-22. Epub 2010 Aug 15.
PubMed 22691935Narang D, Sood S, Thomas MK, Dinda AK, Maulik SK. Effect of dietary palm olein oil on oxidative stress associated with ischemic-reperfusion injury in isolated rat heart. BMC Pharmacol. 2004 Nov 9;4:29. doi: 10.1186/1471-2210-4-29.
PubMed 15535879Scholtz SC, Pieters M, Oosthuizen W, Jerling JC, Bosman MJ, Vorster HH. The effect of red palm olein and refined palm olein on lipids and haemostatic factors in hyperfibrinogenaemic subjects. Thromb Res. 2004;113(1):13-25. doi: 10.1016/j.thromres.2004.02.004.
PubMed 15081561van Jaarsveld PJ, Benade AJ. Effect of palm olein oil in a moderate-fat diet on low-density lipoprotein composition in non-human primates. Asia Pac J Clin Nutr. 2002;11 Suppl 7:S416-23. doi: 10.1046/j.1440-6047.11.s.7.2.x.
PubMed 12492628Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12.
PubMed 19082851Zhang J, Wang CR, Xue AN, Ge KY. Effects of red palm oil on serum lipids and plasma carotenoids level in Chinese male adults. Biomed Environ Sci. 2003 Dec;16(4):348-54.
PubMed 15011966
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Palm Olein and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT02263183
- Acronym / sponsor ID
- PD164/12
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Metabolic risk, Abdominally overweight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Malaysia Palm Oil BoardOther government
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Oct 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.
Red palm oil is obtained from crude palm oil through a novel low-temperature process. Owing to this special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients that include carotenes, vitamin E, phytosterols, phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10. These phytonutrients are the main constituents through which palm oil exhibits its nutritional properties. Among the major health promoting properties are anti-cancer, cardio-protection, anti-angiogenesis, cholesterol inhibition, brain development and neuro-protective properties, antioxidative defence mechanisms, provitamin A activity and anti-diabetes. As red palm oil has variety of phytonutrients and health benefits, the potential of improved cardiovascular health should be considered to understand better and thus treasure more our golden oil.
Detailed description
The oil palm Elaeis guineesis, is the source of palm oil - the 'tropical golden oil'. Malaysia is the world's largest exporter of this golden oil. Triglycerides constitute the major component of crude palm oil, with smaller proportions of diglycerides and monoglycerides. The oil also contains other minor constituents, such as free fatty acids and phytonutrients. This composition determines the oil's physical, chemical and physiological characteristics. In food application, palm oil not only imparts functional properties as a heating medium (as in frying of foods) and in having spreadability (as in formulations for solid fat products like margarines and shortenings), but is also a good source of phytonutrients. Although the phytonutrients constitute only about 1% of its weight in crude palm oil, these are the main constituents through which palm oil exhibits its nutritional properties. Among the major health promoting properties shown to be associated with the various types of phytonutrients present in palm oil are anti-cancer, cardio-protection and anti-angiogenesis, cholesterol inhibition, brain development and neuro-protective properties, antioxidative defence mechanisms, provitamin A activity and anti-diabetes. Red palm oil (RPO) is obtained from crude palm oil through a novel low-temperature process. Owing to this special process, RPO possesses a special flavour and aroma, and is rich in phytonutrients that include carotenes (thus giving the oil a bright red colour), vitamin E, phytosterols, phospholipids, squalene, phenolic acids, flavonoids and co-enzyme Q10.
Little is known about the physiological effects of red palm oil. The link between dietary fats and cardiovascular diseases has always been controversial in the context of palm oil. Narang et al., 2004 demonstrated that the anti-oxidant vitamins in palm olein play a vital role in the protection of the rat's heart against oxidative stress induced by ischemic-reperfusion injury. The unique isomeric position of its fatty acids and the presence of tocotrienols cause the endogenous cholesterol level to drop. Besides palm oil could reduce the risk of arterial thrombosis and atherosclerosis, inhibit endogenous cholesterol biosynthesis, platelet aggregation, and reduce blood pressure. The composition of palm oil with an unsaturated-to-saturated fatty acid ratio close to one and rich in antioxidants vitamins could attenuate the progression of salt-induced hypertension and mortality in rats by modulation of endothelial function and reduction in oxidative stress. In Chinese diet preparation, Zhang et al.,2003 demonstrated that red palm oil is a good source of carotenoids and vitamin E, and it could significantly increase plasma concentration of alpha-carotene, beta-carotene, lycopene and alpha-tocopherol. Following a chronic human study, Scholtz et al., 2004 observed that red palm olein had less detrimental effects on the lipid profile and decreased tissue plasminogen activator antigen as compared to palm olein. As red palm oil has variety of phytonutrients and health benefits, the potential of improved cardiovascular health should be considered to understand better and thus treasure more our golden oil. The present study was designed to investigate the effect of consumption of red palm olein on inflammatory and metabolic risk markers
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| red palm olein(labelled A) | Active comparator | Dietary Supplement: Red Palm Oleinred palm olein (labelled A) |
| palm olein(labelled B)(control) | Placebo comparator | Dietary Supplement: Palm Oleinpalm olein(labelled B)(control) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female), age between 20-60 years and BMI ≥18.5kgm2 will be recruited.
Key exclusion criteria (10 listed)
- Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes
- Blood glucose; >7.0 mmol/L
- Serum triacylglycerol; >4.5 mmol/L
- Serum total cholesterol; >6.5 mmol/L
- Body mass index <18.5 kg/m2
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 |
|---|---|---|
| Red Palm OleinAlso: CarotinoRed Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E) | Dietary supplement | red palm olein(labelled A) |
| Palm OleinAlso: CarotinoPalm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E) | Dietary supplement | palm olein(labelled B)(control) |
Primary outcome
Changes in plasma Interleukin-6 status
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Results publication: PubMed 16326639Bayorh MA, Abukhalaf IK, Ganafa AA. Effect of palm oil on blood pressure, endothelial function and oxidative stress. Asia Pac J Clin Nutr. 2005;14(4):325-39.
- Results publication: PubMed 16028723Choo YM, Ng MH, Ma AN, Chuah CH, Hashim MA. Application of supercritical fluid chromatography in the quantitative analysis of minor components (carotenes, vitamin E, sterols, and squalene) from palm oil. Lipids. 2005 Apr;40(4):429-32. doi: 10.1007/s11745-006-1400-6.
- Results publication: PubMed 12602939Edem DO. Palm oil: biochemical, physiological, nutritional, hematological, and toxicological aspects: a review. Plant Foods Hum Nutr. 2002 Fall;57(3-4):319-41. doi: 10.1023/a:1021828132707.
- Results publication: PubMed 22691935Loganathan R Jr, Selvaduray KR, Nesaretnam K, Radhakrishnan AK. Health promoting effects of phytonutrients found in palm oil. Malays J Nutr. 2010 Aug;16(2):309-22. Epub 2010 Aug 15.
- Results publication: PubMed 15535879Narang D, Sood S, Thomas MK, Dinda AK, Maulik SK. Effect of dietary palm olein oil on oxidative stress associated with ischemic-reperfusion injury in isolated rat heart. BMC Pharmacol. 2004 Nov 9;4:29. doi: 10.1186/1471-2210-4-29.
- Results publication: PubMed 15081561Scholtz SC, Pieters M, Oosthuizen W, Jerling JC, Bosman MJ, Vorster HH. The effect of red palm olein and refined palm olein on lipids and haemostatic factors in hyperfibrinogenaemic subjects. Thromb Res. 2004;113(1):13-25. doi: 10.1016/j.thromres.2004.02.004.
- Results publication: PubMed 12492628van Jaarsveld PJ, Benade AJ. Effect of palm olein oil in a moderate-fat diet on low-density lipoprotein composition in non-human primates. Asia Pac J Clin Nutr. 2002;11 Suppl 7:S416-23. doi: 10.1046/j.1440-6047.11.s.7.2.x.
- Results publication: PubMed 19082851Volek JS, Phinney SD, Forsythe CE, Quann EE, Wood RJ, Puglisi MJ, Kraemer WJ, Bibus DM, Fernandez ML, Feinman RD. Carbohydrate restriction has a more favorable impact on the metabolic syndrome than a low fat diet. Lipids. 2009 Apr;44(4):297-309. doi: 10.1007/s11745-008-3274-2. Epub 2008 Dec 12.
- Results publication: PubMed 15011966Zhang J, Wang CR, Xue AN, Ge KY. Effects of red palm oil on serum lipids and plasma carotenoids level in Chinese male adults. Biomed Environ Sci. 2003 Dec;16(4):348-54.
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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.
Radhika Loganathan, Masters principal investigator
Malaysia Palm Oil Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Palm Olein and Palm Olein in people with Cardiovascular Risk Factor, 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Sep 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 in plasma Interleukin-6 status (time frame: 3 years). 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 NCT02263183, which also lists 9 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 14 Sep 2016.