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Effects of CLA Supplements on Body Weight and Fat Oxidation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dale Schoeller, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00204932
First received: September 12, 2005
Last updated: December 18, 2014
Last verified: December 2014
  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:


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

Primary Outcome Measures:
  • Fat Mass [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    loss of fat mass, kg


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 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Dale Schoeller, Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00204932     History of Changes
Other Study ID Numbers: 2004-0060
Study First Received: September 12, 2005
Results First Received: August 4, 2011
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015