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Completed

NCT Number: NCT00529828

Health Effects of CLA Versus Industrial Trans Fatty Acids

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University, Division of Human Nutrition

Wageningen, 6703 HD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consumption of CLA enriched food

Procedure

Primary outcomes

  1. Total cholesterol

  2. HDL cholesterol

  3. LDL cholesterol

  4. Apo B

  5. Triglycerides

Secondary outcomes

  1. Insulin status markers : HOMA; QUICKY

  2. Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg

  3. Fatty acid composition of cholesteryl esters and erythrocytes

  4. proteomics

  5. iso-prostanes

  6. blood pressure and heart rate

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • VU University of Amsterdam

Registry information

Official study title

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

Acronym: CLARINeT

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 14, 2007
Registry last updated
Jan 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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