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Effects of CLA Supplements on Body Weight and Fat Oxidation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00204932
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : December 22, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:
Conjugated linoleic acid (CLA) is form of fat found in dairy foods, beef and other natural sources. When given to small animals, decreases of body fat have been noted.. Although weight loss is the best treatment for overweight and obesity, it is difficult to maintain the loss in the long term. Because of this, treatment emphasis has turned to small weight losses obtained through non-restrictive diets and prevention of weight regain. This is a study to determine if 6 months of consumption a purified form of CLA will result in greater loss of body fat than control and to determine whether CLA consumption increases total fat oxidation, which would help explain why the weight loss occurs.

Condition or disease Intervention/treatment Phase
Obesity Drug: conjugated linoleic acid Phase 2

Detailed Description:
Subjects were screened and then underwent baseline evaluation. The substudy evaluation measured 24-h energy expenditure and substrate utilization by using a whole-room indirect calorimeter. Dietary fat oxidation was measured by mixing [1-13C]oleate and D31-palmitate into a breakfast meal and then collecting breath carbon dioxide and urine to measure the end products of oxidation. Subjects were then provided either 4 g/d of 78% active CLA isomers (3.2 g/d: 39.2% cis-9,trans-11 and 38.5% trans-10,cis-12) or 4 g/d of safflower oil placebo as 1-g gel capsule supplements. The baseline evaluations were repeated 6 mo later.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of CLA Supplements on Body Weight and Fat Oxidation
Study Start Date : July 2004
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CLA treatment
The group randomized to Conjugated Linoleic Acid (CLA) treatment at 4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA; and 22% safflower oil for 6 months
 Drug: conjugated linoleic acid
4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months
Placebo Comparator: Placebo
The group randomized to control received 4 g/d of safflower oil.
 Drug: conjugated linoleic acid
4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. Fat Mass [ Time Frame: 6 months ]
    loss of fat mass, kg


Secondary Outcome Measures :
  1. Total Fat Oxidation [ Time Frame: 6 months ]
    24 hour respiratory gas analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 25-29.9 kg/m2
  • Absence of a weight change of greater than 3 kg in the previous 6 months

Exclusion Criteria:

  • Presence of a physical limitation to walking exercise
  • Current or recent (6 months) enrollment in a commercial or self-prescribed weight loss program
  • A history of metabolic disease-ie. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study
  • A history of a psychiatric or eating disorders Ÿ Presence of metal implants that would interfere with body composition analysis
  • Fasting plasma cholesterol >300mg/dl or triglycerides above 500 mg/dl.
  • Abnormal EKG
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00204932


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Study Chair: Dale A Schoeller, PhD University of Wisconsin, Madison
Principal Investigator: Dale A Schoeller, PhD University of Wisconsin, Madison
More Information
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Publications of Results:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204932    
Other Study ID Numbers: 2004-0060
First Posted: September 20, 2005    Key Record Dates
Results First Posted: December 22, 2014
Last Update Posted: July 17, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Body Weight