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

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

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Obesity

Intervention / Treatment
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* Behavioral: Low carbohydrate ketogenic diet
* Drug: Orlistat
* Behavioral: Low-fat diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Carbohydrate Ketogenic Diet<br>Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake. | Behavioral: Low carbohydrate ketogenic diet<br>* A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.<br>|
| Active Comparator: Low-Fat Diet plus Orlistat<br>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. | Drug: Orlistat<br>* In addition to the low fat diet, Orlistat is taken 3 times daily.<br>* Other names: Xenical;Behavioral: Low-fat diet<br>* Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Body Weight at 48 Weeks | Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes. | baseline and 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks | Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks. | baseline and 48 weeks | 
| Change From Baseline in Blood Sugar at 48 Weeks | Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks. | Baseline and 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss