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

US Department of Veterans Affairs146 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

146

Conditions

Diabetes Mellitus Obesity

Interventions

Low carbohydrate ketogenic dietBEHAVIORAL

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

OrlistatDRUG

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

Low-fat dietBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Durham VA Medical Center HSR&D COE

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline and 48 weeks

Secondary Outcomes

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.

Time frame: baseline and 48 weeks

Change From Baseline in Blood Sugar at 48 Weeks

Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.

Time frame: Baseline and 48 weeks

Data from ClinicalTrials.gov

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