Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449462
• Other study ID #: NL15420.081.06
• Status: Completed
• Phase: N/A
• First received: March 19, 2007
• Last updated: July 5, 2007
• Start date: March 2007
• Est. completion date: June 2007

Study information

• Verified date: March 2007
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Procedure:
• consumption of CLA enriched food

Locations

Country	Name	City	State
Netherlands	VU University Amsterdam, Institute for Health Sciences	Amsterdam
Netherlands	Wageningen University, Division of Human Nutrition	Wageningen

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen University	VU University of Amsterdam

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ALAT
Primary	ASAT
Primary	amylase
Primary	bilirubin
Primary	alkaline phosphatase
Primary	gamma-glutamyltranspeptidase
Primary	lactate dehydrogenase
Primary	creatinine clearance
Secondary	total cholesterol
Secondary	HDL cholesterol
Secondary	LDL cholesterol
Secondary	triglycerides
Secondary	fatty acids