NCT02263183

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

September 22, 2014

Last Update Submit

September 13, 2016

Conditions

Cardiovascular Risk Factor

Keywords

Metabolic riskAbdominally overweight

Outcome Measures

Primary Outcomes (1)

  • Changes in plasma Interleukin-6 status

    3 years

Other Outcomes (4)

  • Changes in inflammatory response

    3 years

  • Changes in endothelial function

    3 years

  • Changes in lipid profile

    3 years

  • +1 more other outcomes

Study Arms (2)

red palm olein(labelled A)

ACTIVE COMPARATOR

red palm olein (labelled A)

Dietary Supplement: Red Palm Olein

palm olein(labelled B)(control)

PLACEBO COMPARATOR

palm olein(labelled B)(control)

Dietary Supplement: Palm Olein

Interventions

Red Palm OleinDIETARY_SUPPLEMENT

Red Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E)

Also known as: Carotino
red palm olein(labelled A)
Palm OleinDIETARY_SUPPLEMENT

Palm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E)

Also known as: Carotino
palm olein(labelled B)(control)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Alcohol intake exceeding a moderate intake (\>28 units per week)
  • Breastfeeding or pregnant
  • Consume supplement such as herbs and hormone pills
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaysia Palm Oil Board

Kajang, Selangor, 50720, Malaysia

Location

Related Publications (9)

  • 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.

    PMID: 16326639RESULT

  • Choo 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.

    PMID: 16028723RESULT

  • Edem 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.

    PMID: 12602939RESULT

  • Loganathan 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.

    PMID: 22691935RESULT

  • Narang 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.

    PMID: 15535879RESULT

  • Scholtz 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.

    PMID: 15081561RESULT

  • van 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.

    PMID: 12492628RESULT

  • Volek 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.

    PMID: 19082851RESULT

  • Zhang 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.

    PMID: 15011966RESULT

Study Officials

  • Radhika Loganathan, Masters

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2014

First Posted

October 13, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

MY(1)