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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
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by:
Wageningen University

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.


Condition or disease Intervention/treatment Phase
Healthy Procedure: Consumption of CLA enriched food Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
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



Primary Outcome Measures :
  1. Total cholesterol
  2. HDL cholesterol
  3. LDL cholesterol
  4. Apo B
  5. Triglycerides

Secondary Outcome Measures :
  1. Insulin status markers : HOMA; QUICKY
  2. Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
  3. Fatty acid composition of cholesteryl esters and erythrocytes
  4. proteomics
  5. iso-prostanes
  6. blood pressure and heart rate


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-65 years
  • healthy

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands, 6703 HD
Sponsors and Collaborators
Wageningen University
VU University of Amsterdam
Investigators
Principal Investigator: Ingeborg Brouwer, Dr. VU University of Amsterdam
Principal Investigator: Martijn Katan, Prof. Dr. VU University of Amsterdam

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00529828     History of Changes
Other Study ID Numbers: NL15599.081.07
First Posted: September 14, 2007    Key Record Dates
Last Update Posted: January 16, 2008
Last Verified: January 2008

Keywords provided by Wageningen University:
CLA
Industrial trans fatty acids
Oleic acid
Controlled dietary trial