N/A
N=160
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Diabetes Mellitus · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00108524 ↗Enrolled (actual)
160
Serious AEs
2.1%
Results posted
Dec 2013
Primary outcome: Primary: Change From Baseline in Body Weight at 48 Weeks — -9.5; -8.5 percentage of weight loss
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low carbohydrate ketogenic diet (Behavioral); Orlistat (Drug); Low-fat diet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight at 48 Weeks |
-9.5; -8.5 | — |
| SECONDARY Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks |
-1.91; -8.29 | — |
| SECONDARY Change From Baseline in Blood Sugar at 48 Weeks |
-9.74; -3.54 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00108524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.