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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Obesity

In brief

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

Key facts

Study ID

NCT00108524

Run by

US Department of Veterans Affairs

People needed

146

Starts

2004-07-01

Expected to finish

2007-12-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Durham VA Medical Center HSR&D COE — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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