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CompletedNCT01841645Updated May 3, 2013

CLA Metabolism and Effects on Human Health

An interventional study of CLA depletion-repletion in Dietary Modification, Inflammation and Body Composition, Beneficial, sponsored by Alexandre Guedes Torres. Completed at 1 site in Brazil. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by Alexandre Guedes Torres · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dietary Modification
  • Inflammation
  • Body Composition, Beneficial

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Keywords

  • CLA-enriched butter
  • CLA metabolism
  • inflammation
03

In context

Inflammation

3,520 studies on the registry are indexed under Inflammation; 638 are open to participants now.

This study's enrollment of 29 is below the median of 50 across 2,496 interventional studies indexed under Inflammation.

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Lead sponsor

This is the only study on the registry with Alexandre Guedes Torres as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Use of dietary supplements;
  • Smoker;
  • Alcoholic;
  • Under medication;
  • History of chronic disease
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Other
    CLA depletion-repletion

    Dietary Supplement: CLA depletion-repletion

Interventions

  • Dietary supplementCLA depletion-repletion
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 16 weeks

07

Study locations

1 site
  • Federal University of Rio de Janeiro
    Rio de Janeiro, Rio de Janeiro 21941-909, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01841645
Lead sponsor
Alexandre Guedes Torres
Collaborators
Rio de Janeiro State University
Responsible party
Alexandre Guedes Torres (Professor Alexandre Guedes Torres, Universidade Federal do Rio de Janeiro) — Sponsor-investigator
First posted
Apr 26, 2013
Start date
Jul 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
May 3, 2013

Study contacts

Alexandre G Torres, DSc
principal investigator · Universidade Federal do Rio de Janeiro

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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