CLA Metabolism and Effects on Human Health

Not Applicable

Completed

• Conditions: Dietary Modification; Inflammation; Body Composition, Beneficial
• Interventions: Dietary Supplement: CLA depletion-repletion

• Registration Number: NCT01841645
• Lead Sponsor: Alexandre Guedes Torres

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Study First Submitted: 2013-04-17
• Study First Submitted QC: 2013-04-23
• Study First Posted: 2013-04-26
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-02
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLA depletion-repletion	CLA depletion-repletion	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Federal University of Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil