Health Effects of CLA Versus Industrial Trans Fatty Acids (CLARINeT)

Wageningen University

Status

Completed

Conditions

Healthy

Treatments

Procedure: Consumption of CLA enriched food

Study type

Interventional

Funder types

Other

Identifiers

NCT00529828

NL15599.081.07

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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