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
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Obesity||Behavioral: Low carbohydrate ketogenic diet Drug: Orlistat Behavioral: Low-fat diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 69 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
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
|United States, North Carolina|
|Durham VA Medical Center HSR&D COE|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||William S. Yancy, MD MHS||Durham VA Medical Center HSR&D COE|
|Responsible Party:||US Department of Veterans Affairs|
|Other Study ID Numbers:||
|First Posted:||April 18, 2005 Key Record Dates|
|Results First Posted:||December 12, 2013|
|Last Update Posted:||April 17, 2014|
|Last Verified:||March 2014|
Body Weight Changes
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents