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

Tracking Information

First Received Date ^ICMJE

March 19, 2007

Last Updated Date

July 5, 2007

Start Date ^ICMJE

March 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00449462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

total cholesterol
HDL cholesterol
LDL cholesterol
triglycerides
fatty acids

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

Official Title ^ICMJE

The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Procedure: consumption of CLA enriched food

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00449462

Responsible Party

Study ID Numbers ^ICMJE

NL15420.081.06

Study Sponsor ^ICMJE

Wageningen University

Collaborators ^ICMJE

VU University of Amsterdam

Investigators ^ICMJE

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

Information Provided By

Wageningen University

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP