Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108524
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2005-04-15
Brief Title:
A Low-Carbohydrate Ketogenic Diet Versus Orlistat for Weight Loss
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Low-Carbohydrate Ketogenic Diet Versus Orlistat for Weight Loss
Status:
COMPLETED
Status Verified Date:
2014-03
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:
This study compares two types of diet interventions a low carbohydrate ketogenic diet Atkins and a low-fat diet combined with a medication Orlistat
Detailed Description:
Overweight and obesity are increasingly prevalent in the veteran population as well as the general public For patients with obesity-associated illnesses there are few effective treatment options available after failed attempts at diet and exercise even though weight loss has been shown to alleviate these conditions The purpose of this study is to compare the tolerability safety and efficacy of a low-carbohydrate ketogenic diet Atkins with a combination of a low-fat diet and Orlistat The outcomes examined over a 48 week duration will include body weight risk factors for heart disease eg lipid profiles and blood sugar This is a randomized parallel-intervention trial Subjects n150 will be recruited from the Durham VAMC Ambulatory Care Clinics All patients receive one of the two intensive weight loss interventions
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