A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss

Not Applicable

Completed

Interventions: Behavioral: Low carbohydrate ketogenic diet
Drug: Orlistat
Behavioral: Low-fat diet

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 (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.

Recruitment & Eligibility

Inclusion Criteria

Participants must have a VA medical center primary care provider;
Failed first line diet and exercise recommendations;
In stable health by screening physical and lab tests;
Agrees to make regular visits per study protocol;
Has access to telephone;
Body mass index (BMI) > or = 27 with obesity-related illness OR BMI > or = 30 with no risk factors;
No contraindications to Orlistat;
Not pregnant or breast-feeding;
No serious mental health illness such as dementia or schizophrenia;
No use of a weight loss therapy in the month prior to screening.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Low-Fat Diet plus Orlistat	Low-fat diet	Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.
Low Carbohydrate Ketogenic Diet	Low carbohydrate ketogenic diet	Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Low-Fat Diet plus Orlistat	Orlistat	Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight at 48 Weeks	baseline and 48 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks	baseline and 48 weeks	Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.
Change From Baseline in Blood Sugar at 48 Weeks	Baseline and 48 weeks	Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.