This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

This study has been completed.
VU University of Amsterdam
Information provided by:
Wageningen University Identifier:
First received: March 19, 2007
Last updated: July 5, 2007
Last verified: March 2007

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
Intervention Model: Single Group Assignment
Masking: None (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:

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.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00449462

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00449462     History of Changes
Other Study ID Numbers: NL15420.081.06
Study First Received: March 19, 2007
Last Updated: July 5, 2007

Keywords provided by Wageningen University:
kidney processed this record on September 21, 2017