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Effects of CLA Supplements on Body Weight and Fat Oxidation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204932
First Posted: September 20, 2005
Last Update Posted: May 31, 2017
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.
Information provided by (Responsible Party):
University of Wisconsin, Madison
September 12, 2005
September 20, 2005
August 4, 2011
December 22, 2014
May 31, 2017
July 2004
January 2008   (Final data collection date for primary outcome measure)
Fat Mass [ Time Frame: 6 months ]
loss of fat mass, kg
loss of body fat
Complete list of historical versions of study NCT00204932 on ClinicalTrials.gov Archive Site
Total Fat Oxidation [ Time Frame: 6 months ]
Blood chemistries and general well being
Total Fat Oxidation
Not Provided
Not Provided
 
Effects of CLA Supplements on Body Weight and Fat Oxidation
Effects of CLA Supplements on Body Weight and Fat Oxidation
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Obesity
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
  • 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
    Intervention: Drug: conjugated linoleic acid
  • Placebo Comparator: Placebo
    The group randomized to control received 4 g/d of safflower oil.
    Intervention: Drug: conjugated linoleic acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
January 2008
January 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 44 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00204932
2004-0060
Yes
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Study Chair: Dale A Schoeller, PhD University of Wisconsin, Madison
Principal Investigator: Dale A Schoeller, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP