Conditions: Diabetes Mellitus Obesity
Keywords: anti-obesity agents diet therapy diet, reducing obesity overweight risk factors weight loss
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 146
Healthy volunteers: yes

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.

Arms:
arm 1: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. arm 2: 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.

Interventions: intervention 1: Low carbohydrate ketogenic diet intervention 2: Orlistat intervention 3: Low-fat diet
Intervention descriptions: intervention 1: A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat. intervention 2: In addition to the low fat diet, Orlistat is taken 3 times daily. intervention 3: Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

Protocol document: