Clinical trial NCT02245113: Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: Universiti Putra Malaysia
name: International Medical University
First posted: 2014-09-19
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: change in c-peptide level
timeFrame: week 0(baseline) and week 6
Secondary outcomes:
measure: change in insulin resistance's markers
timeFrame: week 0(baseline) and week 6
measure: change in inflammatory markers
timeFrame: week 0(baseline) and week 6
measure: change in obesity markers
timeFrame: week 0(baseline) and week 6
measure: change in lipid profile
timeFrame: week 0(baseline) and week 6
measure: change in physical characteristic (eg. BMI, body weight)
timeFrame: week 0(baseline) and week 6
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: MPOB
state: Selangor
Study officials:
affiliation: MPOB
name: Voon Phooi Tee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UPM
name: Lee Sin Tien, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UPM
name: Norhaizan Md Esa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMU
name: Tony Ng Kock Wai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IMU
name: Verna Lee Kar Mun, PhD
role: PRINCIPAL_INVESTIGATOR
References: