NCT00449462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2007

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 6, 2007

Status Verified

March 1, 2007

First QC Date

March 19, 2007

Last Update Submit

July 5, 2007

Conditions

Healthy

Keywords

CLAliverkidney

Outcome Measures

Primary Outcomes (8)

  • ALAT

  • ASAT

  • amylase

  • bilirubin

  • alkaline phosphatase

  • gamma-glutamyltranspeptidase

  • lactate dehydrogenase

  • creatinine clearance

Secondary Outcomes (5)

  • total cholesterol

  • HDL cholesterol

  • LDL cholesterol

  • triglycerides

  • fatty acids

Interventions

consumption of CLA enriched foodPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • use of cholesterol lowering medication
  • high alcohol intake
  • BMI \> 30
  • chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VU University Amsterdam, Institute for Health Sciences

Amsterdam, Netherlands

Location

Wageningen University, Division of Human Nutrition

Wageningen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19932729DERIVED

Study Officials

  • Ingeborg A Brouwer, PhD

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR

  • Martijn B Katan, Professor

    VU University of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 20, 2007

Study Start

March 1, 2007

Study Completion

June 1, 2007

Last Updated

July 6, 2007

Record last verified: 2007-03

Locations

NL(2)