NCT00108524

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
BEHAVIORAL	Low carbohydrate ketogenic diet	A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
DRUG	Orlistat	In addition to the low fat diet, Orlistat is taken 3 times daily.
BEHAVIORAL	Low-fat diet	Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-04-18
• Last updated: 2014-04-17
• Results posted: 2013-12-12

Locations

1 site across 1 country: United States