Health Effects of CLA Versus Industrial Trans Fatty Acids (CLARINeT)
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|ClinicalTrials.gov Identifier: NCT00529828|
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : January 16, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Procedure: Consumption of CLA enriched food||Not Applicable|
It will be a double-blind randomized multiple cross-over trial with 3 treatments:
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
- Total cholesterol
- HDL cholesterol
- LDL cholesterol
- Apo B
- 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
- blood pressure and heart rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00529828
|Wageningen University, Division of Human Nutrition|
|Wageningen, Netherlands, 6703 HD|
|Principal Investigator:||Ingeborg Brouwer, Dr.||VU University of Amsterdam|
|Principal Investigator:||Martijn Katan, Prof. Dr.||VU University of Amsterdam|