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

Study Overview
=================
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

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

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Other: Novel Olein
* Other: Novel Olein


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-cholesterol |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive protein |  | 5 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, LDL, Oleic acid, Palmitic acid, trans fatty acid, C-reactive protein