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Effects of CLA Supplements on Body Weight and Fat Oxidation

Primary Purpose

Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
conjugated linoleic acid
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CLA treatment

Placebo

Arm Description

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

The group randomized to control received 4 g/d of safflower oil.

Outcomes

Primary Outcome Measures

Fat Mass
loss of fat mass, kg

Secondary Outcome Measures

Total Fat Oxidation
24 hour respiratory gas analysis

Full Information

First Posted
September 12, 2005
Last Updated
June 18, 2018
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT00204932
Brief Title
Effects of CLA Supplements on Body Weight and Fat Oxidation
Official Title
Effects of CLA Supplements on Body Weight and Fat Oxidation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CLA treatment
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The group randomized to control received 4 g/d of safflower oil.
Intervention Type
Drug
Intervention Name(s)
conjugated linoleic acid
Intervention Description
4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months
Primary Outcome Measure Information:
Title
Fat Mass
Description
loss of fat mass, kg
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total Fat Oxidation
Description
24 hour respiratory gas analysis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale A Schoeller, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dale A Schoeller, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16924272
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. doi: 10.1038/sj.ijo.0803437. Epub 2006 Aug 22.
Results Reference
result
PubMed Identifier
17823448
Citation
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. doi: 10.1093/ajcn/86.3.797.
Results Reference
result

Learn more about this trial

Effects of CLA Supplements on Body Weight and Fat Oxidation

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