Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study

Sponsor

Malaysia Palm Oil Board (Other)

Overall Status

Completed

CT.gov ID

NCT00715312

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: The effect of positional distribution of dietary fatty acids on markers of inflammation and blood lipids metabolites on diets containing fatty acids such as oleic acid that are associated with reduced risk of cardiovascular disease is not widely studied.

Hypothesis: There would be difference detected in the concentrations of markers of inflammation and blood lipid metabolites in human volunteers fed controlled diets.

Study design: A randomized, double-blind, crossover clinical trial that involves 41 healthy volunteers. The volunteers will be selected based on inclusion and exclusion criteria. They will consume controlled diets for 5 weeks that provides 15% of energy from protein, 30% of energy from fat, and 55% of energy from carbohydrates. Volunteers will be assigned to each test diets which is cooked with novel olein, palm stearin or partially hydrogenated soybean oil in random order until all three diets has consumed by each person.

Main study parameters: LDL-cholesterol

Condition or Disease	Intervention/Treatment	Phase
Inflammation	Other: Novel Olein Other: Novel Olein	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study.

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Other: Novel Olein A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake Other: Novel Olein A total of 70g of test oil is incorporated into cooked meal which provides 30-35% of calorie

Arm

Intervention/Treatment

Experimental: A

Other: Novel Olein

A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake

Other: Novel Olein

A total of 70g of test oil is incorporated into cooked meal which provides 30-35% of calorie

Outcome Measures

Primary Outcome Measures

LDL-cholesterol [5 weeks]

Secondary Outcome Measures

C-reactive protein [5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy and free from any disease and absence of family history for arteriosclerosis or hypertension
Not on any medication or supplements or weight loss program
Non smokers and alcoholics