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Conjugated Linoleic Acid in Obese Women (CLA)

Primary Purpose

Lipid Metabolism Disorders, Obesity

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CLA
Placebo
Sponsored by
Universidade Estadual de Londrina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipid Metabolism Disorders

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Had no signs or symptoms of disease
  • No orthopedic injuries
  • Must be inactive or moderately active (defined as performing any type of physical exercise less than twice a week)
  • Must be non-smokers
  • Must be free from the use of ergogenic aids
  • Had no metabolic disorders or chronic degenerative diseases
  • Not use drug therapy for body mass loss.

Exclusion Criteria:

  • Had frequency to training sessions below 85% of the total sessions

Sites / Locations

  • Universidade Estadual de Londrina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aerobic exercise associated with CLA

Aerobic exercise

Arm Description

CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%).

Placebo group received 4 g/day of olive oil.

Outcomes

Primary Outcome Measures

Body fat
Dual-energy X-ray absorptiometry

Secondary Outcome Measures

Total cholesterol
Blood analysis
Triglycerides
Blood analysis
High-density lipoprotein
Blood analysis
Low-density lipoprotein
Estimated by Friedewald formula
Trunk fat
Dual-energy X-ray absorptiometry
Arm fat
Dual-energy X-ray absorptiometry
Leg fat
Dual-energy X-ray absorptiometry

Full Information

First Posted
August 4, 2015
Last Updated
August 18, 2015
Sponsor
Universidade Estadual de Londrina
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1. Study Identification

Unique Protocol Identification Number
NCT02529046
Brief Title
Conjugated Linoleic Acid in Obese Women
Acronym
CLA
Official Title
Effect of Conjugated Linoleic Acid Associated With Aerobic Exercise on Body Fat and Lipid Profile in Obese Women: A Randomized, Double-blinded and Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual de Londrina

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this trial, the investigators analyzed the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women.
Detailed Description
The aim of this investigation was to analyze the effects of eight weeks of CLA supplementation associated with aerobic exercise on body fat and lipid profile in obese women. The investigators performed a randomized, double-blinded and placebo-controlled trial with 28 obese women who received 3.2 g/d of CLA or 4 g/d of olive oil (placebo group) while performing an 8-week protocol of aerobic exercise. Dietary intake (food record), body fat (DXA) and biochemical analysis (blood sample) were assessed before and after the intervention period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic exercise associated with CLA
Arm Type
Active Comparator
Arm Description
CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%).
Arm Title
Aerobic exercise
Arm Type
Placebo Comparator
Arm Description
Placebo group received 4 g/day of olive oil.
Intervention Type
Dietary Supplement
Intervention Name(s)
CLA
Intervention Description
CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). Aerobic exercise associated with CLA
Intervention Type
Behavioral
Intervention Name(s)
Placebo
Intervention Description
Placebo group received 4 g/day of olive oil. Aerobic exercise
Primary Outcome Measure Information:
Title
Body fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Total cholesterol
Description
Blood analysis
Time Frame
8 weeks
Title
Triglycerides
Description
Blood analysis
Time Frame
8 weeks
Title
High-density lipoprotein
Description
Blood analysis
Time Frame
8 weeks
Title
Low-density lipoprotein
Description
Estimated by Friedewald formula
Time Frame
8 weeks
Title
Trunk fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Title
Arm fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Title
Leg fat
Description
Dual-energy X-ray absorptiometry
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Body mass
Description
Urano, model PS 180
Time Frame
8 weeks
Title
Maximum oxygen uptake
Description
incremental treadmill test
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Had no signs or symptoms of disease No orthopedic injuries Must be inactive or moderately active (defined as performing any type of physical exercise less than twice a week) Must be non-smokers Must be free from the use of ergogenic aids Had no metabolic disorders or chronic degenerative diseases Not use drug therapy for body mass loss. Exclusion Criteria: Had frequency to training sessions below 85% of the total sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edilson Cyrino, PhD
Organizational Affiliation
Universidade Estadual de Londrina
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Estadual de Londrina
City
Londrina
State/Province
Paraná
ZIP/Postal Code
86.057-970
Country
Brazil

12. IPD Sharing Statement

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Conjugated Linoleic Acid in Obese Women

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