NCT01841645

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

April 17, 2013

Last Update Submit

May 2, 2013

Conditions

Dietary ModificationInflammationBody Composition, Beneficial

Keywords

CLA-enriched butterCLA metabolisminflammation

Outcome Measures

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.

    16 weeks

Study Arms (1)

CLA depletion-repletion

OTHER
Dietary Supplement: CLA depletion-repletion

Interventions

CLA depletion-repletionDIETARY_SUPPLEMENT
CLA depletion-repletion

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-909, Brazil

Location

MeSH Terms

Conditions

InflammationGlucocorticoid Receptor Deficiency

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre G Torres, DSc

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Alexandre Guedes Torres

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 26, 2013

Study Start

July 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

BR(1)