Overview
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Status:
Completed
Completed
Trial end date:
2007-12-01
2007-12-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
US Department of Veterans AffairsVA Office of Research and Development
Treatments:
OrlistatCriteria
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