NCT00347373

Brief Summary

The purpose of this clinical trial is to examine the effects of a low and high dose of conjugated linoleic acid supplement on body composition in obese humans. Individuals with a body mass index between 30 and 35kg/m2 are randomized to receive either placebo, 3.2gCLA, or 6.4g CLA daily for twelve weeks. Changes in body composition, weight, and clinical laboratory values are compared between the three groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Aug 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 4, 2006

Status Verified

June 1, 2006

First QC Date

June 30, 2006

Last Update Submit

June 30, 2006

Conditions

Obesity

Keywords

conjugated linoleic acidobesitybody compositionbody fat masslean body mass

Outcome Measures

Primary Outcomes (5)

  • Change in body fat mass at 12 weeks

  • Change in lean body mass at 12 weeks

  • Change in body mass index at 12 weeks

  • Change in body weight at 12 weeks

  • Change in energy expenditure at 12 weeks

Secondary Outcomes (2)

  • Change in lipid profile at 6 weeks and 12 weeks

  • Change in clinical laboratory values at 6 weeks and 12 weeks (safety)

Interventions

Tonalin Conjugated linoleic acid (dietary supplement)DRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 30 and 35 kg/m2

You may not qualify if:

  • history of chronic disease
  • food allergies or intolerances
  • drug therapy for diagnosed disease or lipid-lowering
  • use of weight-lowering medication or diet
  • use of tobacco products
  • current or planned pregnancy
  • use of CLA supplement in previous 3 months
  • current substance abuse
  • abnormal clinical laboratory values

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Susan E Steck, PhD, MPH, RD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

August 1, 2004

Study Completion

September 1, 2005

Last Updated

July 4, 2006

Record last verified: 2006-06

Locations

US(1)