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CompletedNCT00449462Updated Jul 6, 2007

Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

An interventional study of consumption of CLA enriched food in Healthy, sponsored by Wageningen University. Completed at 2 sites in Netherlands. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-07-06.

Sponsored by Wageningen University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • CLA
  • liver
  • kidney
03

In context

Lead sponsor

Wageningen University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • use of cholesterol lowering medication
  • high alcohol intake
  • BMI > 30
  • chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • Procedureconsumption of CLA enriched food
06

What researchers measure

Primary outcomes

  1. ALAT

  2. ASAT

  3. amylase

  4. bilirubin

  5. alkaline phosphatase

  6. gamma-glutamyltranspeptidase

  7. lactate dehydrogenase

  8. creatinine clearance

Secondary outcomes

  1. total cholesterol

  2. HDL cholesterol

  3. LDL cholesterol

  4. triglycerides

  5. fatty acids

07

Study locations

2 sites
  • VU University Amsterdam, Institute for Health Sciences
    Amsterdam, Netherlands
  • Wageningen University, Division of Human Nutrition
    Wageningen, Netherlands
08

References and documents

Publications

  • Wanders AJ, Leder L, Banga JD, Katan MB, Brouwer IA. A high intake of conjugated linoleic acid does not affect liver and kidney function tests in healthy human subjects. Food Chem Toxicol. 2010 Feb;48(2):587-90. doi: 10.1016/j.fct.2009.11.036. Epub 2009 Nov 22. PubMed 19932729 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00449462
Lead sponsor
Wageningen University
Collaborators
VU University of Amsterdam
First posted
Mar 20, 2007
Start date
Mar 2007
Completion
Jun 2007
Last update
Jul 6, 2007

Study contacts

Ingeborg A Brouwer, PhD
principal investigator · VU University of Amsterdam
Martijn B Katan, Professor
principal investigator · VU University of Amsterdam

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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