Health Effects of CLA Versus Industrial Trans Fatty Acids
CLARINeT
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Sep 2007
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 12, 2007
CompletedFirst Posted
Study publicly available on registry
September 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJanuary 16, 2008
January 1, 2008
4 months
September 12, 2007
January 10, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Total cholesterol
HDL cholesterol
LDL cholesterol
Apo B
Triglycerides
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- age 18-65 years
- healthy
You may not qualify if:
- serum total cholesterol \>= 6,5 mmol/L
- serum triglycerides \> 2,3 mmol/L
- chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- use of cholesterol lowering medication
- use of blood pressure lowering medication
- high alcohol intake
- BMI \> 30
- pregnant and lactation women
- unusual dietary requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- VU University of Amsterdamcollaborator
Study Sites (1)
Wageningen University, Division of Human Nutrition
Wageningen, 6703 HD, Netherlands
Related Publications (2)
Smit LA, Katan MB, Wanders AJ, Basu S, Brouwer IA. A high intake of trans fatty acids has little effect on markers of inflammation and oxidative stress in humans. J Nutr. 2011 Sep;141(9):1673-8. doi: 10.3945/jn.110.134668. Epub 2011 Jul 13.
PMID: 21753062DERIVEDWanders AJ, Brouwer IA, Siebelink E, Katan MB. Effect of a high intake of conjugated linoleic acid on lipoprotein levels in healthy human subjects. PLoS One. 2010 Feb 3;5(2):e9000. doi: 10.1371/journal.pone.0009000.
PMID: 20140250DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Ingeborg Brouwer, Dr.
VU University of Amsterdam
- PRINCIPAL INVESTIGATOR
Martijn Katan, Prof. Dr.
VU University of Amsterdam
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2007
First Posted
September 14, 2007
Study Start
September 1, 2007
Primary Completion
January 1, 2008
Study Completion
January 1, 2008
Last Updated
January 16, 2008
Record last verified: 2008-01