Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Novel Olein
Novel Olein
Sponsored by

About this trial
This is an interventional prevention trial for Inflammation focused on measuring Inflammation, LDL, Oleic acid, Palmitic acid, trans fatty acid, C-reactive protein
Eligibility Criteria
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
Exclusion Criteria:
- Having some health-related problems e.g fever, flu, allergy, chronic diseases
- On some treatment or medication
- Smokers and alcoholics
Sites / Locations
- Malaysia Palm Oil Board
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
LDL-cholesterol
Secondary Outcome Measures
C-reactive protein
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00715312
Brief Title
Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study
Official Title
Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Malaysia Palm Oil Board
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Inflammation, LDL, Oleic acid, Palmitic acid, trans fatty acid, C-reactive protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Novel Olein
Intervention Description
A total of 70g of test oil is incorporated into cooked meal which accounts for 30-35% of calorie intake
Intervention Type
Other
Intervention Name(s)
Novel Olein
Intervention Description
A total of 70g of test oil is incorporated into cooked meal which provides 30-35% of calorie
Primary Outcome Measure Information:
Title
LDL-cholesterol
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
C-reactive protein
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Exclusion Criteria:
Having some health-related problems e.g fever, flu, allergy, chronic diseases
On some treatment or medication
Smokers and alcoholics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teng Kim Tiu
Organizational Affiliation
Malaysia Palm Oil Board
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysia Palm Oil Board
City
Kajang
State/Province
Selangor
ZIP/Postal Code
50720
Country
Malaysia
12. IPD Sharing Statement
Learn more about this trial
Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study
We'll reach out to this number within 24 hrs