Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00449462

Enrollment

Registered

2007-03-20

Start date

2007-03-31

Completion date

2007-06-30

Last updated

2007-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

CLA, liver, kidney

Brief 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.

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.

Interventions

PROCEDUREconsumption of CLA enriched food

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
creatinine clearance	—
amylase	—
bilirubin	—
alkaline phosphatase	—
gamma-glutamyltranspeptidase	—
lactate dehydrogenase	—
ALAT	—
ASAT	—

Secondary

Measure	Time frame
HDL cholesterol	—
LDL cholesterol	—
triglycerides	—
fatty acids	—
total cholesterol	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026