Health Effects of CLA Versus Industrial Trans Fatty Acids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Consumption of CLA enriched food

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes