Fat Quality on Blood Lipids and Immune Response

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate blood LDL-cholesterol and level of inflammatory markers after intake of food items with different fatty acid composition.

Conditions
-----------------
Dietary Prevention

Intervention / Treatment
-----------------
* Other: Food items


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hsCRP < 10 mg/L total cholesterol 5-7.8 mmol/l(50-70 y) total cholesterol 5.0-6.9 mmol/l (30-49 y) total cholesterol 5.0-6.1 mmol/l (25-29 y) LDL-cholesterol at or above 3.5 mmol/l triglycerides at or lower 2.6 mmol/l BMI 20-35 Stable bodyweight last 3 months. Exclusion Criteria: Chronic diseases fasting glucose > 6.0 mmol/l increased ASAT and ALAT medications affecting lipidmetabolism and inflammation

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Food items<br>Food items low in saturated fat and high in polyunsaturated fat | Other: Food items<br>* Food items with different fatty acid composition<br>|
| Placebo Comparator: Control food items<br>Food items containing saturated fat and polyunsaturated fat according to a traditional Norwegian diet | Other: Food items<br>* Food items with different fatty acid composition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL-cholesterol | Change in LDL-cholesterol when compared to control diet | Change from baseline after 8 weeks | 
| Change in total cholesterol | Change in total cholesterol when compared to control diet | Change from baseline after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers in circulation and at gene expression level in PBMC |  | Inflammatory markers are measured at baseline and after 8 weeks intervention in circulation and at gene expression level in PBMC | 
| Markers of lipid metabolism at gene expression level in PBMC |  | Markers of lipid metabolism at gene expression level in PBMC is measured at baseline and after 8 weeks of intervention | 
| Appetite hormones |  | Appetite hormones is measured at baseline and after 8 weeks of intervention | 
| Gut peptides |  | Gut peptides are measured at baseline and after 8 weeks of intervention | 
| Metabolites | Targeted and untargeted metabolomics will be measured | Metabolites are measured at baseline and after 8 weeks of intervention | 
| Whole genome gene expression | Microarray | whole genome gene expression profiles are measured at baseline and after 8 weeks of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LDL-cholesterol