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Completed

NCT Number: NCT01841645

CLA Metabolism and Effects on Human Health

The purpose of the study is to investigate the effects of Conjugated Linoleic Acid (CLA) from dairy products on fatty acid metabolism and human health. A CLA depletion-repletion study was carried out with healthy volunteers. CLA depletion was achieved through an eight-week dairy fat restriction, followed by an eight-week repletion period consisting of intake of a butter naturally enriched with CLA. Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid composition of lipid classes are evaluated after depletion and repletion phases.

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Key information

Conditions

Dietary Modification Body Composition, Beneficial Glucocorticoid Receptor Deficiency Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio de Janeiro

Rio de Janeiro, 21941-909, Brazil

About this study

After collecting baseline blood samples, CLA-depletion phase started with dietary orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their diets any type of dairy fat for the following 8 weeks. Blood samples were taken at the end of CLA-depletion, and CLA-repletion phase was initiated by dietitians' instructions: volunteers returned to their regular diets, and additionally consumed a CLA-enriched butter for another 8-week period. Blood samples were taken at the end of the CLA-repletion phase. The effects of CLA on the following parameters were evaluated: inflammatory mediators; fatty acid composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition; clinical factors associated with the metabolic syndrome and indicators of cell membranes' stability.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers;
  • 20 to 40 years;
  • BMI between 18.0 and 29.9 kg/m2.

Exclusion criteria

  • Use of dietary supplements;
  • Smoker;
  • Alcoholic;
  • Under medication;
  • History of chronic disease

Treatment and study plan

CLA depletion-repletion

Dietary Supplement

Primary outcomes

  1. Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention

    Time frame: 16 weeks

    Changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membrane stability, plasma lipid levels and fatty acid composition of lipid classes were evaluated before and after depletion and repletion phases.

Sponsors and collaborators

Lead sponsor

Alexandre Guedes Torres

Other

Collaborators

  • Rio de Janeiro State University

Registry information

Official study title

Conjugated Linoleic Acid (CLA) Depletion-repletion: Metabolism and Bioactivity in Humans

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 26, 2013
Registry last updated
May 3, 2013

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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