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

NCT ID: NCT00108524

Last Updated: 2014-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-12-31

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.

Conditions

Diabetes Mellitus; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Carbohydrate Ketogenic Diet

Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.

Group Type: EXPERIMENTAL

Low carbohydrate ketogenic diet

Intervention Type: BEHAVIORAL

A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.

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.

Group Type: ACTIVE_COMPARATOR

Orlistat

Intervention Type: DRUG

In addition to the low fat diet, Orlistat is taken 3 times daily.

Low-fat diet

Intervention Type: BEHAVIORAL

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

Interventions

Low carbohydrate ketogenic diet

A low-carb diet limits carbohydrates - such as grains, starchy vegetables and fruit - and emphasizes dietary protein and fat.

Intervention Type: BEHAVIORAL

Orlistat

In addition to the low fat diet, Orlistat is taken 3 times daily.

Intervention Type: DRUG

Low-fat diet

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Xenical

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William S. Yancy, MD MHS

Role: PRINCIPAL_INVESTIGATOR

Durham VA Medical Center HSR&D COE

Locations

Durham VA Medical Center HSR&D COE

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 23911112 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19212822 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20101008 (View on PubMed)

Other Identifiers

CLIN-005-03F

Identifier Type: -

Identifier Source: org_study_id