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

US Department of Veterans Affairs (VA)

Status: Completed

Conditions: Diabetes Mellitus; Obesity

Treatments: Behavioral: Low carbohydrate ketogenic diet; Behavioral: Low-fat diet; Drug: Orlistat

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00108524

CLIN-005-03F

Details and patient eligibility

About

This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

• No VAMC primary care provider
• Unable to attend regular study visits
• No access to telephone
• BMI < 27
• Contraindications to Orlistat
• Pregnancy, breast feeding or planning to become pregnant
• Unstable mental health illness
• Use of a weight loss therapy in the month prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Low Carbohydrate Ketogenic Diet

Experimental group

Description:

Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.

Treatment:

Behavioral: Low carbohydrate ketogenic diet

Low-Fat Diet plus Orlistat

Active Comparator group

Description:

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.

Treatment:

Behavioral: Low-fat diet

Drug: Orlistat