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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00108524
• Other study ID #: CLIN-005-03F
• Status: Completed
• Phase: N/A
• First received: April 15, 2005
• Last updated: March 26, 2014
• Start date: July 2004
• Est. completion date: December 2007

Study information

• Verified date: March 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Durham VA Medical Center HSR&D COE	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

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/do — View 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. — View 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/archint — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 48 weeks	No
Secondary	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.	baseline and 48 weeks	Yes
Secondary	Change From Baseline in Blood Sugar at 48 Weeks	Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.	Baseline and 48 weeks	No