NCT00204932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

December 22, 2014

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

8 months

First QC Date

September 12, 2005

Results QC Date

August 4, 2011

Last Update Submit

June 18, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Fat Mass

    loss of fat mass, kg

    6 months

Secondary Outcomes (1)

  • Total Fat Oxidation

    6 months

Study Arms (2)

CLA treatment

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: conjugated linoleic acid

Interventions

conjugated linoleic acidDRUG

4 grams per day of 39% cis-9, trans-11 CLA; 39% trans-10, cis-12 CLA, and 22% safflower oil for 6 months

CLA treatmentPlacebo

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25-29.9 kg/m2
  • Absence of a weight change of greater than 3 kg in the previous 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (2)

  • 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.

    PMID: 16924272RESULT

  • 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.

    PMID: 17823448RESULT

MeSH Terms

Conditions

Obesity

Interventions

Linoleic Acids, Conjugated

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Linoleic AcidsFatty Acids, Omega-6Fatty Acids, UnsaturatedFatty AcidsLipids

Results Point of Contact

Title
Dale Schoeller Principal Investigator
Organization
U Wisconsin-Madison
dschoell@nutrisci.wisc.edu
608-262-1082

Study Officials

  • Dale A Schoeller, PhD

    University of Wisconsin, Madison

    STUDY CHAIR

  • Dale A Schoeller, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

July 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

July 17, 2018

Results First Posted

December 22, 2014

Record last verified: 2018-06

Locations

US(1)