- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00449462
Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function
July 5, 2007 updated by: Wageningen University
The Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function in Healthy Volunteers (CLAxon-Study)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amsterdam, Netherlands
- VU University Amsterdam, Institute for Health Sciences
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Wageningen, Netherlands
- Wageningen University, Division of Human Nutrition
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
creatinine clearance
|
bilirubin
|
ALAT
|
ASAT
|
amylase
|
alkaline phosphatase
|
gamma-glutamyltranspeptidase
|
lactate dehydrogenase
|
Secondary Outcome Measures
Outcome Measure |
---|
HDL cholesterol
|
LDL cholesterol
|
total cholesterol
|
triglycerides
|
fatty acids
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ingeborg A Brouwer, PhD, VU University of Amsterdam
- Principal Investigator: Martijn B Katan, Professor, VU University of Amsterdam
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
March 19, 2007
First Submitted That Met QC Criteria
March 19, 2007
First Posted (Estimate)
March 20, 2007
Study Record Updates
Last Update Posted (Estimate)
July 6, 2007
Last Update Submitted That Met QC Criteria
July 5, 2007
Last Verified
March 1, 2007
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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