CLA Metabolism and Effects on Human Health

NCT ID: NCT01841645

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-10-31

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.

Conditions

Dietary Modification; Inflammation; Body Composition, Beneficial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CLA depletion-repletion

Group Type: OTHER

CLA depletion-repletion

Intervention Type: DIETARY_SUPPLEMENT

Interventions

CLA depletion-repletion

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: collaborator

Alexandre Guedes Torres

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Guedes Torres

Professor Alexandre Guedes Torres

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexandre G Torres, DSc

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro

Locations

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

Countries

Brazil

Other Identifiers

AGT2013

Identifier Type: -

Identifier Source: org_study_id