Effect of Conjugated Linoleic Acid Intake on Liver and Ki... | NCT00449462

Studies
Effect of Conjugated Linoleic Acid Intake on Liver and Kidney Function

NCT00449462

Sponsor

Wageningen University

Status

Completed

Last Update Posted

Jul 6, 2007Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

consumption of CLA enriched food

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Mar 19, 2007

First Submission Date that Met QC Criteria

Mar 19, 2007

First Posted Date

Mar 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2007

Last Update Posted Date

Jul 6, 2007Estimated

Name	Class
VU University of Amsterdam	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
consumption of CLA enriched food	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ALAT
ASAT
amylase
bilirubin
alkaline phosphatase
gamma-glutamyltranspeptidase
lactate dehydrogenase
creatinine clearance

Secondary Outcomes

Measure	Description	Time Frame
total cholesterol
HDL cholesterol
LDL cholesterol

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingeborg A Brouwer, PhD	VU University of Amsterdam	Principal Investigator
Martijn B Katan, Professor	VU University of Amsterdam	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VU University Amsterdam, Institute for Health Sciences		Amsterdam			Netherlands
Wageningen University, Division of Human Nutrition

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19932729	Derived	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.