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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108524
First received: April 15, 2005
Last updated: March 26, 2014
Last verified: March 2014
  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
Diabetes Mellitus
Obesity
Behavioral: Low carbohydrate ketogenic diet
Drug: Orlistat
Behavioral: 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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Change From Baseline in Body Weight at 48 Weeks [ Time Frame: baseline and 48 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 48 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.


Enrollment: 146
Study Start Date: July 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108524

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

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108524     History of Changes
Other Study ID Numbers: CLIN-005-03F
Study First Received: April 15, 2005
Results First Received: September 26, 2013
Last Updated: March 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
anti-obesity agents
diet therapy
diet, reducing
obesity
overweight
risk factors
weight loss

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 September 11, 2014