Back to resultsCLA Metabolism and Effects on Human Health
Primary Purpose
Dietary Modification, Inflammation, Body Composition, Beneficial
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CLA depletion-repletion
Sponsored by
About this trial
This is an interventional basic science trial for Dietary Modification focused on measuring CLA-enriched butter, CLA metabolism, inflammation
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
Sites / Locations
- Federal University of Rio de Janeiro
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CLA depletion-repletion
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01841645
First Posted
April 17, 2013
Last Updated
May 2, 2013
Sponsor
Alexandre Guedes Torres
Collaborators
Rio de Janeiro State University
1. Study Identification
Unique Protocol Identification Number
NCT01841645
Brief Title
CLA Metabolism and Effects on Human Health
Official Title
Conjugated Linoleic Acid (CLA) Depletion-repletion: Metabolism and Bioactivity in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexandre Guedes Torres
Collaborators
Rio de Janeiro State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Modification, Inflammation, Body Composition, Beneficial
Keywords
CLA-enriched butter, CLA metabolism, inflammation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLA depletion-repletion
Arm Type
Other
Intervention Type
Dietary Supplement
Intervention Name(s)
CLA depletion-repletion
Primary Outcome Measure Information:
Title
Fatty acid metabolism and inflammatory mediators were accompanied during a CLA depletion-repletion dietary intervention
Description
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre G Torres, DSc
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-909
Country
Brazil
12. IPD Sharing Statement
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CLA Metabolism and Effects on Human Health
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