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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715312
• Other study ID #: 625.9
• Status: Completed
• Phase: N/A
• First received: July 11, 2008
• Last updated: July 14, 2008
• Start date: February 2008
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of HealthUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
Malaysia	Malaysia Palm Oil Board	Kajang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-cholesterol		5 weeks	No
Secondary	C-reactive protein		5 weeks	No