Efficacy of Orlistat 60 mg on Weight Loss and Body Fat Mass in US Army Soldiers

Abstract

A higher body mass index is associated with exercise-related injuries and increased risk for musculoskeletal and connective tissue disorders, which are relevant to military personnel. Studies show the efficacy of orlistat 60 mg for promoting weight and body fat loss in civilians; however, its efficacy among predominantly young, male soldiers is unknown. This study's objective was to examine the effect of a 6-month, standard education-based weight-management program with and without orlistat 60 mg on changes in weight and body fat in overweight soldiers. Data were collected for this randomized, controlled trial from March 2008 to November 2010 at Fort Bragg, NC. Participants were enrolled in an education-based weight management program (n=435; 75% men) and were randomized to placebo or orlistat 60 mg, three capsules daily with meals. All participants were recommended to maintain a reduced-energy, low-fat diet. Among study completers (14% retention rate; placebo n=22, orlistat n=35) members of both groups lost significant weight from baseline (placebo −3.0±5.2 kg; orlistat −3.2±4.7 kg; P<0.01), but only the orlistat group lost fat mass (−2.5±3.9 kg; P<0.001), whereas the placebo group lost lean mass (−1.4±2.7 kg; P <0.01). An intent-to-treat analysis (≥1 follow-up body weight measure) demonstrated that the orlistat group lost more fat mass vs the placebo group (−1.3±2.9 kg vs −0.6±1.8 kg, respectively; P<0.05), but less lean mass (−0.2±2.0 kg vs −0.8±1.8 kg, respectively; P<0.01). Orlistat 60 mg may be an effective adjunct to an education-based weight management program in a mostly young, male soldier population.