Effects of High Oleic Palm Olein, Virgin Olive Oil and Coconut Oil Diets on Markers Selected in Malaysian

Overweight Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245113
• Other study ID #: R002302000
• Status: Completed
• Phase: N/A
• First received: September 17, 2014
• Last updated: September 18, 2014
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: September 2014
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• diets
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.

Locations

Country	Name	City	State
Malaysia	MPOB	Kajang	Selangor

Sponsors (3)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	International Medical University, Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in c-peptide level		week 0(baseline) and week 6	No
Secondary	change in insulin resistance's markers		week 0(baseline) and week 6	No
Secondary	change in inflammatory markers		week 0(baseline) and week 6	No
Secondary	change in obesity markers		week 0(baseline) and week 6	No
Secondary	change in lipid profile		week 0(baseline) and week 6	No
Secondary	change in physical characteristic (eg. BMI, body weight)		week 0(baseline) and week 6	No