Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

This study has been completed.

First Received on March 19, 2007. Last Updated on July 5, 2007 History of Changes

Sponsor:	Wageningen University
Collaborator:	VU University of Amsterdam
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00449462

Purpose

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.

Condition	Intervention
Healthy	Procedure: consumption of CLA enriched food

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)

Further study details as provided by Wageningen University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

total cholesterol
HDL cholesterol
LDL cholesterol
triglycerides
fatty acids

Estimated Enrollment:	20
Study Start Date:	March 2007
Study Completion Date:	June 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449462

Locations

Netherlands
VU University Amsterdam, Institute for Health Sciences
Amsterdam, Netherlands
Wageningen University, Division of Human Nutrition
Wageningen, Netherlands

Sponsors and Collaborators

Wageningen University

VU University of Amsterdam

Investigators

Principal Investigator:	Ingeborg A Brouwer, PhD	VU University of Amsterdam
Principal Investigator:	Martijn B Katan, Professor	VU University of Amsterdam

More Information

No publications provided by Wageningen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wanders AJ, Leder L, Banga JD, Katan MB, Brouwer IA. A high intake of conjugated linoleic acid does not affect liver and kidney function tests in healthy human subjects. Food Chem Toxicol. 2010 Feb;48(2):587-90. Epub 2009 Nov 22.

ClinicalTrials.gov Identifier:	NCT00449462 History of Changes
Other Study ID Numbers:	NL15420.081.06
Study First Received:	March 19, 2007
Last Updated:	July 5, 2007
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:

CLA
liver
kidney

ClinicalTrials.gov processed this record on February 12, 2012