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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00108524
Recruitment Status : Completed
First Posted : April 18, 2005
Results First Posted : December 12, 2013
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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Brief 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Obesity Behavioral: Low carbohydrate ketogenic diet Drug: Orlistat Behavioral: Low-fat diet Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Study Start Date : July 2004
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Orlistat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Low Carbohydrate Ketogenic Diet
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
 Behavioral: Low carbohydrate ketogenic diet
A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
Active Comparator: Low-Fat Diet plus Orlistat
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
In addition to the low fat diet, Orlistat is taken 3 times daily.
Other Name: Xenical

Behavioral: Low-fat diet
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Body Weight at 48 Weeks [ Time Frame: baseline and 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.


Secondary Outcome Measures :
  1. Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks [ Time Frame: baseline and 48 weeks ]
    Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.

  2. Change From Baseline in Blood Sugar at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
    Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108524


Locations
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United States, North Carolina
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: William S. Yancy, MD MHS Durham VA Medical Center HSR&D COE
More Information
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Publications of Results:

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108524    
Other Study ID Numbers: CLIN-005-03F
First Posted: April 18, 2005    Key Record Dates
Results First Posted: December 12, 2013
Last Update Posted: April 17, 2014
Last Verified: March 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
anti-obesity agents
diet therapy
diet, reducing
obesity
 overweight
risk factors
weight loss
Additional relevant MeSH terms:
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Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Body Weight Changes
Orlistat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Obesity Agents
Lipid Regulating Agents