Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function - Full Text View

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Sponsors and Collaborators

Wageningen University

University of Amsterdam

Investigators


Principal Investigator:	Ingeborg A Brouwer, PhD	University of Amsterdam

Principal Investigator:	Martijn B Katan, Professor	University of Amsterdam

More Information

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

Keywords provided by Wageningen University:

CLA

liver

kidney

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Wageningen University University of Amsterdam
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00449462