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Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

NCT ID: NCT00449462

Last Updated: 2007-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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consumption of CLA enriched food

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VU University of Amsterdam

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Principal Investigators

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Ingeborg A Brouwer, PhD

Role: PRINCIPAL_INVESTIGATOR

VU University of Amsterdam

Martijn B Katan, Professor

Role: PRINCIPAL_INVESTIGATOR

VU University of Amsterdam

Locations

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VU University Amsterdam, Institute for Health Sciences

Amsterdam, , Netherlands

Site Status

Wageningen University, Division of Human Nutrition

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 19932729 (View on PubMed)

Other Identifiers

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NL15420.081.06

Identifier Type: -

Identifier Source: org_study_id