Health Effects of CLA Versus Industrial Trans Fatty Acids

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00529828
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Status Verified: 2008-01
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Last Update Submitted: 2008-01-10
• Last Update Posted: 2008-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Total cholesterol
HDL cholesterol
LDL cholesterol
Apo B
Triglycerides

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wageningen University, Division of Human Nutrition; 🇳🇱 Wageningen, Netherlands