Overview

This trial is active, not recruiting.

Condition cardiovascular risk factor
Treatments red palm olein, palm olein
Sponsor Malaysia Palm Oil Board
Start date January 2013
End date December 2015
Trial size 53 participants
Trial identifier NCT02263183, PD164/12

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose prevention
Arm
(Active Comparator)
red palm olein (labelled A)
red palm olein Carotino
Red Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E)
(Placebo Comparator)
palm olein(labelled B)(control)
palm olein Carotino
Palm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E)

Primary Outcomes

Measure
Changes in plasma Interleukin-6 status
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Additional Information

Official title Red Palm Olein and Cardiovascular Health
Principal investigator Radhika Loganathan, Masters
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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Malaysia Palm Oil Board.