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Effects of CLA Supplements on Body Weight and Fat Oxidation

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204932
First received: September 12, 2005
Last updated: April 5, 2010
Last verified: April 2010
History of Changes
  Purpose

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 Intervention Phase
Obesity
 Drug: conjugated linoleic acid
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of CLA Supplements on Body Weight and Fat Oxidation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • loss of body fat [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body fatness


Secondary Outcome Measures:
  • total fat oxidation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Blood chemistries and general well being


Enrollment: 53
Study Start Date: July 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CLA Drug: conjugated linoleic acid
Placebo Comparator: Placebo Drug: conjugated linoleic acid

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204932

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

No publications provided

Responsible Party: Dale A. Schoeller, University of Wisconsin-Madison
ClinicalTrials.gov Identifier: NCT00204932     History of Changes
Other Study ID Numbers: 2004-0060
Study First Received: September 12, 2005
Last Updated: April 5, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Body Weight
Obesity
Signs and Symptoms
 Overnutrition
Nutrition Disorders
Overweight

ClinicalTrials.gov processed this record on May 19, 2013