Effects of CLA Supplements on Body Weight and Fat Oxidation

Obesity Clinical Trial

Official title:

Effects of CLA Supplements on Body Weight and Fat Oxidation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204932
• Other study ID #: 2004-0060
• Status: Completed
• Phase: Phase 2
• Start date: July 2004
• Est. completion date: March 2005

Study information

• Verified date: June 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (2)

Close RN, Schoeller DA, Watras AC, Nora EH. Conjugated linoleic acid supplementation alters the 6-mo change in fat oxidation during sleep. Am J Clin Nutr. 2007 Sep;86(3):797-804. — View Citation

Watras AC, Buchholz AC, Close RN, Zhang Z, Schoeller DA. The role of conjugated linoleic acid in reducing body fat and preventing holiday weight gain. Int J Obes (Lond). 2007 Mar;31(3):481-7. Epub 2006 Aug 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat Mass	loss of fat mass, kg	6 months
Secondary	Total Fat Oxidation	24 hour respiratory gas analysis	6 months