Health Effects of CLA Versus Industrial Trans Fatty Acids (CLARINeT)

January 10, 2008 updated by: Wageningen University

Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)

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 CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will be a double-blind randomized multiple cross-over trial with 3 treatments:

  • CLA;
  • Industrial trans fatty acids (as a positive control);
  • Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.

Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6703 HD
        • Wageningen University, Division of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-65 years
  • healthy

Exclusion Criteria:

  • serum total cholesterol >= 6,5 mmol/L
  • serum triglycerides > 2,3 mmol/L
  • chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
  • use of cholesterol lowering medication
  • use of blood pressure lowering medication
  • high alcohol intake
  • BMI > 30
  • pregnant and lactation women
  • unusual dietary requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglycerides
Apo B

Secondary Outcome Measures

Outcome Measure
Insulin status markers : HOMA; QUICKY
Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
Fatty acid composition of cholesteryl esters and erythrocytes
proteomics
iso-prostanes
blood pressure and heart rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wageningen University

Collaborators

VU University of Amsterdam

Investigators

  • Principal Investigator: Ingeborg Brouwer, Dr., VU University of Amsterdam
  • Principal Investigator: Martijn Katan, Prof. Dr., VU University of Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (ESTIMATE)

September 14, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

January 16, 2008

Last Update Submitted That Met QC Criteria

January 10, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NL15599.081.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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