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Completed

NCT Number: NCT00347373

Effect of Conjugated Linoleic Acid Supplement on Body Composition

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

Sixty healthy obese adult volunteers will be enrolled and randomized into either: 1) placebo, 2) 3.2 g CLA, or 3) 6.4 g CLA groups and supplemented for 12 weeks. Body fat mass (BFM) and lean body mass will be determined by DEXA at baseline and twelve weeks during the intervention. In addition, indirect calorimetry will be performed at baseline and twelve weeks to measure changes in energy expenditure. The effect of CLA supplementation on weight, waist and hip measurements, and BMI will also be determined at 12 weeks. Plasma CLA and pill counts will be measured as an indication of compliance. Several blood parameters will be monitored throughout the study, and five random 24-hour recall surveys will be used to monitor dietary intake of CLA-rich foods, energy, micronutrients and antioxidants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 30 and 35 kg/m2

Exclusion criteria

  • 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

Treatment and study plan

Tonalin Conjugated linoleic acid (dietary supplement)

Drug

Primary outcomes

  1. Change in body fat mass at 12 weeks

  2. Change in lean body mass at 12 weeks

  3. Change in body mass index at 12 weeks

  4. Change in body weight at 12 weeks

  5. Change in energy expenditure at 12 weeks

Secondary outcomes

  1. Change in lipid profile at 6 weeks and 12 weeks

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

Sponsors and collaborators

Lead sponsor

University of North Carolina

Other

Collaborators

  • Cognis

Registry information

Official study title

Conjugated Linoleic Acid and Body Fat Mass in Obese Humans

Important dates

Study start
2004
Study completion
2005
First posted
Jul 4, 2006
Registry last updated
Jul 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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