The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.
The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.
Primary Outcome Measures:
- Total cholesterol
- HDL cholesterol
- LDL cholesterol
- Apo B
- Triglycerides
Secondary Outcome Measures:
- Insulin status markers : HOMA; QUICKY
- Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
- Fatty acid composition of cholesteryl esters and erythrocytes
- proteomics
- iso-prostanes
- blood pressure and heart rate
| Estimated Enrollment: |
60 |
| Study Start Date: |
September 2007 |
| Study Completion Date: |
January 2008 |
| Primary Completion Date: |
January 2008 (Final data collection date for primary outcome measure) |
It will be a double-blind randomized multiple cross-over trial with 3 treatments:
- CLA;
- Industrial trans fatty acids (as a positive control);
- Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.
Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.
Purpose
