Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

Wageningen University

Status

Completed

Conditions

Healthy

Treatments

Procedure: consumption of CLA enriched food

Study type

Interventional

Funder types

Other

Identifiers

NCT00449462

NL15420.081.06

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 CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.

Full description

Each volunteer receives CLA enriched products for a total of 3 weeks containing approximately 20g CLA per day. A control group is not needed. If three subjects or more show one or more blood values for liver and kidney function above predefined limits the study will be terminated.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

age 18-60 years
serum total cholesterol < 8.0 mmol/L
serum triglycerides < 3.0 mmol/L
ALAT < 45 IU/L
ASAT < 41 IU/L
amylase 35-130 U/L
alkaline phosphatase 40-125 U/L
bilirubin < 17 µmol/L
gamma-glutamyltranspeptidase > 75 U/L (men) and < 40 U/L (women)
lactate dehydrogenase 230-485 U/L
creatinine clearance >= 90 mL/min
fasting glucose levels 70-115 mg/dL
fasting insulin levels 5-30 mU/L

Exclusion criteria

use of cholesterol lowering medication
high alcohol intake
BMI > 30
chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
pregnancy