Efficacy of Meal Replacements Versus a Standard Food-Based Diet for Weight Loss in Type 2 Diabetes: A Controlled Clinical Trial

Purpose The purpose of this study is to compare the efficacy of aportion-controlled meal replacement diet (PCD) to a standard diet (SD) basedon recommendations by the American Diabetes Association in achieving andmaintaining weight loss among obese participants with type 2 diabetes. Methods This study is a university-based, controlled clinical trial. Participantswere 119 men and women with diabetes with a body mass index between 25 and 40kg/m², assigned randomly to one of two 34-week, 75% of predictedenergy need diets (portion controlled or standard, self-selected, food based)and then followed by 1-year maintenance. Results Using intention-to-treat analyses, weight loss at 34 weeks and weightmaintenance at 86 weeks was significantly better on PCD versus SD.Approximately 40% of the PCD participants lost >=5% of their initial weightcompared with 12% of those on the SD. Significant improvements in biochemicaland metabolic measures were observed at 34 weeks in both groups. The retentionrate and self-reported ease of adherence in the PCD group were significantlyhigher throughout the study. Conclusions A diet using portion-controlled meal replacements yielded significantlygreater initial weight loss and less regain after 1 year of maintenance than astandard, self-selected, food-based diet. As PCDs may help obese patients withtype 2 diabetes adhere to a weight control program, diabetes educators mayconsider recommending them as part of a comprehensive approach to weightcontrol.