A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
| Condition | Intervention |
|---|---|
|
Obesity Diabetes Mellitus |
Behavioral: Low carbohydrate ketogenic diet Drug: Orlistat plus a low-fat diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss |
- Body weight
- Risk factors for heart disease (e.g., lipid profiles)
- Blood sugar
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | April 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided by Department of Veterans Affairs
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00108524 History of Changes |
| Other Study ID Numbers: | CLIN-005-03F |
| Study First Received: | April 15, 2005 |
| Last Updated: | January 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
obesity weight loss diet, reducing anti-obesity agents |
diet therapy risk factors overweight |
Additional relevant MeSH terms:
|
Diabetes Mellitus Obesity Weight Loss Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Body Weight Changes Orlistat Anti-Obesity Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013