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

Sponsored by:	Malaysia Palm Oil Board
Information provided by:	Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:	NCT00715312

Purpose

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	Intervention
Inflammation	Other: Novel Olein

MedlinePlus related topics: Cholesterol

Drug Information available for: Lipids Oleic acid Palmitic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Crossover Assignment
Official Title:	Effect of Oleic Acid on Inflammation Markers and Blood Lipid Metabolites: A Randomised, Double-Blind, Crossover Study.

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:

LDL-cholesterol [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

C-reactive protein [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment:	43
Study Start Date:	February 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715312

Locations

Malaysia, Selangor
Malaysia Palm Oil Board
Kajang, Selangor, Malaysia, 50720

Sponsors and Collaborators

Malaysia Palm Oil Board

Investigators

Principal Investigator:

Teng Kim Tiu

Malaysian Palm Oil Board

More Information

Responsible Party:	Malaysian Palm Oil Board (MPOB) ( Teng Kim Tiu/Ms )
Study ID Numbers:	625.9
Study First Received:	July 11, 2008
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00715312
Health Authority:	Malaysia: Ministry of Health; United States: Federal Government

Keywords provided by Malaysia Palm Oil Board:

Inflammation
LDL
Oleic acid

Palmitic acid
trans fatty acid
C-reactive protein

Study placed in the following topic categories:

Palmitic Acid
Inflammation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009