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

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

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

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Other: Novel Olein; Other: Novel Olein

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LDL-cholesterol	5 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
C-reactive protein	5 weeks

Collaborators and Investigators

• Sponsor: Malaysia Palm Oil Board
• Investigators: Principal Investigator: Teng Kim Tiu, Malaysia Palm Oil Board

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: July 11, 2008
• First Submitted That Met QC Criteria: July 14, 2008
• First Posted (ESTIMATE): July 15, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 15, 2008
• Last Update Submitted That Met QC Criteria: July 14, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Inflammation; C-reactive protein; LDL; trans fatty acid; Palmitic acid; Oleic acid
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 625.9