Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347373
Status:
COMPLETED
Last Update Posted:
2006-07-04
First Post:
2006-06-30
Brief Title:
Effect of Conjugated Linoleic Acid Supplement on Body Composition
Sponsor:
University of North Carolina
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Conjugated Linoleic Acid and Body Fat Mass in Obese Humans
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 35kgm2 are randomized to receive either placebo 32gCLA or 64g CLA daily for twelve weeks Changes in body composition weight and clinical laboratory values are compared between the three groups
Detailed Description:
Sixty healthy obese adult volunteers will be enrolled and randomized into either 1 placebo 2 32 g CLA or 3 64 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None