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Effects of a weight-loss aid in healthy overweight adults: double-blind, placebo-controlled clinical trial

2000; Elsevier BV; Volume: 61; Issue: 4 Linguagem: Inglês

10.1016/s0011-393x(00)89034-7

1879-0313

Douglas Kalman, Carlon M. Colker, Qivhu Shi, Melissa A. Swain,

Muscle metabolism and nutrition

Objective: This study was undertaken to determine the effects of an ephedrine- and synephrine-based compound on body mass, body composition, metabolic variables, and mood states in healthy overweight adults. Methods: Thirty subjects with a body mass index > 27 kg/m2 were assigned randomly to the experimental group or the placebo group. The experimental group received a capsule containing ephedrine alkaloids 20 mg, synephrine 5 mg, caffeine 200 mg, and salicin 15 mg twice daily for 8 weeks, whereas the other group received a matching placebo. A registered dietitian instructed all patients about a 22-kcal/kg National Cholesterol Education Program Step One diet. In addition, all patients performed a cross-training exercise program 3 days per week under the guidance of an exercise physiologist. During the exercise sessions, patients achieved ∼70% of age-predicted maximum heart rate. Results: The experimental group had a significantly greater weight loss compared with the placebo group (3.14 kg vs 2.05 kg, respectively; P < 0.05). The experimental group experienced a 16% decrease in body fat compared with a 1% increase for the placebo group. The between-group difference was significant (P = 0.005). Both groups achieved a significant reduction in fat-free mass; however, the reduction in the placebo group was greater than that of the experimental group. This suggests a muscle-sparing effect in the experimental group. No significant changes in blood pressure, serial electrocardiograms, pulse rate, serum chemistry, or caloric intake were noted. Conclusions: These findings indicate the apparent safety and efficacy of the ephedrine- and synephrine-based compound within the confines of this study.