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OpenTrials
Completed

NCT Number: NCT00449462

Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VU University Amsterdam, Institute for Health Sciences, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consumption of CLA enriched food

Procedure

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

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • VU University of Amsterdam

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2007
First posted
Mar 20, 2007
Registry last updated
Jul 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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