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Effect of Conjugated Linoleic Acid Supplement on Body Composition

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ClinicalTrials.gov Identifier: NCT00347373
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Sponsor:
Collaborator:
Cognis
Information provided by:
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
The purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. Individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or 6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory values are compared between the three groups.

Condition or disease Intervention/treatment Phase
Obesity Drug: Tonalin Conjugated linoleic acid (dietary supplement) Not Applicable

Detailed Description:
Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and lean body mass will be determined by DEXA at baseline and twelve weeks during the intervention. In addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight, waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill counts will be measured as an indication of compliance. Several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Conjugated Linoleic Acid and Body Fat Mass in Obese Humans
Study Start Date : August 2004
Study Completion Date : September 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change in body fat mass at 12 weeks
  2. Change in lean body mass at 12 weeks
  3. Change in body mass index at 12 weeks
  4. Change in body weight at 12 weeks
  5. Change in energy expenditure at 12 weeks

Secondary Outcome Measures :
  1. Change in lipid profile at 6 weeks and 12 weeks
  2. Change in clinical laboratory values at 6 weeks and 12 weeks (safety)

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 30 and 35 kg/m2

Exclusion Criteria:

  • history of chronic disease
  • food allergies or intolerances
  • drug therapy for diagnosed disease or lipid-lowering
  • use of weight-lowering medication or diet
  • use of tobacco products
  • current or planned pregnancy
  • use of CLA supplement in previous 3 months
  • current substance abuse
  • abnormal clinical laboratory values
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347373


Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina
Cognis
Investigators
Principal Investigator: Susan E Steck, PhD, MPH, RD University of North Carolina, Chapel Hill
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00347373     History of Changes
Other Study ID Numbers: GCRC2166
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by University of North Carolina, Chapel Hill:
conjugated linoleic acid
obesity
body composition
body fat mass
lean body mass