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Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

This study has been completed.
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00449462
First received: March 19, 2007
Last updated: July 5, 2007
Last verified: March 2007
History of Changes
  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)

Resource links provided by NLM:

U.S. FDA Resources

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):

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 May 23, 2013