CLA Metabolism and Effects on Human Health

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841645
• Other study ID #: AGT2013
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: May 2, 2013
• Start date: July 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2013
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Dietary Modification
• Inflammation

Intervention

Dietary Supplement:
• CLA depletion-repletion

Locations

Country	Name	City	State
Brazil	Federal University of Rio de Janeiro	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Alexandre Guedes Torres	Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention	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.	16 weeks	No