A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
Behavioral: Low carbohydrate ketogenic diet
Drug: Orlistat plus a low-fat diet
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss|
- Body Weight [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.
- Risk Factors for Heart Disease (e.g., Lipid Profiles) [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]LDL-C, low-density lipoprotein cholesterol
- Blood Sugar [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]Fasting glucose, mg/dL
|Study Start Date:||July 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
|Behavioral: Low carbohydrate ketogenic diet|
Active Comparator: Arm 2
Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
|Drug: Orlistat plus a low-fat diet|
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 (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.
|United States, North Carolina|
|Durham VA Medical Center HSR&D COE|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||William S. Yancy, MD MHS||Durham VA Medical Center HSR&D COE|