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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2007

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.

Interventions

  • Behavioral: Low carbohydrate ketogenic diet
    • A low-carb diet limits carbohydrates – such as grains, starchy vegetables and fruit – and emphasizes dietary protein and fat.
  • Drug: Orlistat
    • In addition to the low fat diet, Orlistat is taken 3 times daily.
  • Behavioral: Low-fat diet
    • Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake

Arms, Groups and Cohorts

  • Experimental: Low Carbohydrate Ketogenic Diet
    • Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 69 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • US Department of Veterans Affairs
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William S. Yancy, MD MHS, Principal Investigator, Durham VA Medical Center HSR&D COE

Citations Reporting on Results

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.

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.

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.

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