Healthy
Conditions
Keywords
CLA, Industrial trans fatty acids, Oleic acid, Controlled dietary trial
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.
Interventions
PROCEDUREConsumption of CLA enriched food
Sponsors
VU University of Amsterdam
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total cholesterol | — |
| HDL cholesterol | — |
| LDL cholesterol | — |
| Apo B | — |
| Triglycerides | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatty acid composition of cholesteryl esters and erythrocytes | — |
| Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg | — |
| proteomics | — |
| iso-prostanes | — |
| blood pressure and heart rate | — |
| Insulin status markers : HOMA; QUICKY | — |
Countries
Netherlands
Outcome results
None listed