Back to resultsA Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Primary Purpose
Diabetes Mellitus, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low carbohydrate ketogenic diet
Orlistat
Low-fat diet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss
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
Sites / Locations
- Durham VA Medical Center HSR&D COE
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low Carbohydrate Ketogenic Diet
Low-Fat Diet plus Orlistat
Arm Description
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change From Baseline in Blood Sugar at 48 Weeks
Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.
Full Information
NCT ID
NCT00108524
First Posted
April 15, 2005
Last Updated
March 26, 2014
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00108524
Brief Title
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Official Title
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Obesity
Keywords
anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Carbohydrate Ketogenic Diet
Arm Type
Experimental
Arm Description
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Arm Title
Low-Fat Diet plus Orlistat
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Low carbohydrate ketogenic diet
Intervention Description
A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.
Intervention Type
Drug
Intervention Name(s)
Orlistat
Other Intervention Name(s)
Xenical
Intervention Description
In addition to the low fat diet, Orlistat is taken 3 times daily.
Intervention Type
Behavioral
Intervention Name(s)
Low-fat diet
Intervention Description
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake
Primary Outcome Measure Information:
Title
Change From Baseline in Body Weight at 48 Weeks
Description
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.
Time Frame
baseline and 48 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks
Description
Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.
Time Frame
baseline and 48 weeks
Title
Change From Baseline in Blood Sugar at 48 Weeks
Description
Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.
Time Frame
Baseline and 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William S. Yancy, MD MHS
Organizational Affiliation
Durham VA Medical Center HSR&D COE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center HSR&D COE
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23911112
Citation
Mayer SB, Jeffreys AS, Olsen MK, McDuffie JR, Feinglos MN, Yancy WS Jr. Two diets with different haemoglobin A1c and antiglycaemic medication effects despite similar weight loss in type 2 diabetes. Diabetes Obes Metab. 2014 Jan;16(1):90-3. doi: 10.1111/dom.12191. Epub 2013 Aug 29.
Results Reference
result
PubMed Identifier
19212822
Citation
Yancy WS Jr, Almirall D, Maciejewski ML, Kolotkin RL, McDuffie JR, Westman EC. Effects of two weight-loss diets on health-related quality of life. Qual Life Res. 2009 Apr;18(3):281-9. doi: 10.1007/s11136-009-9444-8. Epub 2009 Feb 11.
Results Reference
result
PubMed Identifier
20101008
Citation
Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492. Erratum In: JAMA Intern Med. 2015 Mar;175(3):470.
Results Reference
result
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A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
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