Clinical trial NCT00529828: Health Effects of CLA Versus Industrial Trans Fatty Acids
Official title: Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: CLA
Industrial trans fatty acids
Oleic acid
Controlled dietary trial
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
First posted: 2007-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Total cholesterol
measure: HDL cholesterol
measure: LDL cholesterol
measure: Apo B
measure: Triglycerides
Secondary outcomes:
measure: Insulin status markers : HOMA; QUICKY
measure: Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
measure: Fatty acid composition of cholesteryl esters and erythrocytes
measure: proteomics
measure: iso-prostanes
measure: blood pressure and heart rate
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University, Division of Human Nutrition
Study officials:
affiliation: VU University of Amsterdam
name: Ingeborg Brouwer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: VU University of Amsterdam
name: Martijn Katan, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wanders 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.