NCT00529828CompletedNot Applicable
Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wageningen University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total cholesterol
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age 18-65 years
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
Outcomes
Primary Outcomes
Total cholesterol
HDL cholesterol
LDL cholesterol
Apo B
Triglycerides
Secondary Outcomes
- 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
- blood pressure and heart rate
Investigators
Study Sites (1)
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