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Health Services Research & Development

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2008 HSR&D National Meeting Abstract

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National Meeting 2008

3012 — A Randomized Trial of a Low-Carbohydrate Diet Versus Orlistat for Weight Loss in Veteran Outpatients

Yancy, Jr. WS (Durham VAMC), Westman EC (Duke University Medical Center), McDuffie JR (Durham VAMC), Bolton JH (Durham VAMC), Jeffreys AS (Durham VAMC), Grambow SC (Durham VAMC), Chalecki AM (Durham VAMC), Oddone EZ (Durham VAMC)

Objectives:
Weight loss interventions that are effective in veterans and can be integrated into VA outpatient clinics are needed. In randomized trials, low-carbohydrate diets have been more effective than low-fat diets over 6 months, and at least as effective over 1 year; they have not been compared with weight loss medications, however, and have been studied infrequently in medical outpatients.

Methods:
Outpatients with BMI > 27 kg/m2 were recruited from the Durham VAMC and randomized to a low-carbohydrate, ketogenic diet (LCKD; n=72) or orlistat 120 mg thrice daily plus a low-fat, energy-restricted diet (O+LFD; n=74). Subjects received diet, exercise, and behavioral counseling at group meetings (biweekly for 24 weeks, then monthly for 24 weeks). Linear mixed-effects models were used to examine outcomes over the first 24 weeks; 48-week measurements were completed recently.

Results:
Mean age was 52 years; 72% were men, 55% were Black, 42% were White, and 32% had diabetes. Over 24 weeks, model predicted mean (SE) weight change in the O+LFD group was -9.9 (0.8) kg and in the LCKD group, -12.0 (1.1) kg (p=0.1). Waist circumference change in the O+LFD group was -9.3 (0.7) cm and in the LCKD group, -10.7 (1.1) cm (p=0.3). Systolic and diastolic blood pressure changes in the O+LFD group were -1.4 (1.4) and -2.6 (1.0) mm Hg, respectively, and in the LCKD group, -5.2 (1.7) and -4.4 (1.1) mm Hg (p=0.09 and 0.2). Fasting serum triglyceride decreased in both groups (O+LFD: -15%, LCKD: -30%; p=0.1). HDL cholesterol change was more favorable in the LCKD group (O+LFD: +1%, LCKD: +11%; p=0.002), whereas LDL cholesterol change was more favorable in the O+LFD group (O+LFD: -12%, LCKD: +7%; p < 0.001).

Implications:
The LCKD was comparable to O+LFD for weight loss over 6 months duration. Changes in serum lipids were beneficial overall yet dissimilar in the two groups: the LCKD raised HDL cholesterol and the O+LFD lowered LDL cholesterol. These results in medical outpatients are consistent with those seen in healthy volunteers from previous trials of these therapies.

Impacts:
Targeting these weight loss therapies to metabolic profile (and possibly patient preference) could improve cardiovascular disease risk and weight loss in veterans.


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