Randomized controlled trial of the Medifast 5 & 1 Plan for weight loss

J M Shikany, A S Thomas, T M Beasley, C E Lewis, D B Allison, J M Shikany, A S Thomas, T M Beasley, C E Lewis, D B Allison

Abstract

Objective: The Medifast 5 & 1 Plan (MD) is a portion-controlled, nutritionally-balanced, low-fat weight-loss plan. We studied the effects of MD compared with a reduced-energy, food-based diet (FB) on body weight, waist circumference, fat mass and other measures in adults.

Design: We conducted a two-parallel-arm, randomized, controlled trial comparing MD to FB over 52 weeks. A total of 120 men and women aged 19-65 years with BMI 35 and 50 kg m(-2) were randomized to MD (n=60) or FB (n=60). Follow-up included a 26-week weight-loss phase and 26-week weight-maintenance phase. Anthropometric, body composition, biochemical and appetite/satiety measures were performed at baseline and at 26 and 52 weeks. An intention-to-treat, linear mixed models analysis was the primary analysis.

Results: Fifty MD subjects (83.3%) and 45 FB subjects (75.0%) completed the study on assigned treatment. At 26 weeks, race-adjusted mean weight loss was 7.5 kg in MD subjects vs 3.8 kg in FB subjects (P=0.0002 for difference); reduction in waist circumference was 5.7 cm in MD vs 3.7 cm in FB (P=0.0064); and fat mass loss was 6.4 kg in MD vs 3.7 kg in FB (P=0.0011). At 52 weeks, the corresponding reductions were 4.7 vs 1.9 kg (P=0.0004); 5.0 vs 3.6 cm (P=0.0082); and 4.1 vs 1.9 kg (P=0.0019) in MD and FB subjects, respectively.

Conclusion: In obese adults, MD resulted in significantly greater reductions in body weight and fat compared with an FB diet for 1 year after randomization.

Conflict of interest statement

Conflict of Interest: Authors James M. Shikany, Amy S. Thomas, T. Mark Beasley, and Cora E. Lewis have no potential conflicts of interest to report. Dr. Allison has, anticipates, or has had financial interests with the following: Paul, Weiss, Rifkin, Wharton & Garrison, LLP; Kraft Foods, Inc., and Nutrition Impact, LLC, and has received consulting fees from Medifast.

Figures

Figure 1
Figure 1
Consort diagram.

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