Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00449462
• 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 CLAxon-study will be performed to investigate wether high doses of CLA can be safely given to healthy human volunteers.

Detailed 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.

Study Timeline

• Status Verified: 2007-03
• Study Start: 2007-03
• Study First Submitted: 2007-03-19
• Study First Submitted QC: 2007-03-19
• Study First Posted: 2007-03-20
• Study Completion: 2007-06
• Last Update Submitted: 2007-07-05
• Last Update Posted: 2007-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
lactate dehydrogenase
creatinine clearance
ALAT
ASAT
amylase
bilirubin
alkaline phosphatase
gamma-glutamyltranspeptidase

Secondary Outcome Measures

Name	Time	Method
total cholesterol
HDL cholesterol
LDL cholesterol
triglycerides
fatty acids

Trial Locations

Locations (2)

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

VU University Amsterdam, Institute for Health Sciences; 🇳🇱 Amsterdam, Netherlands