The effect of leptin, caffeine/ephedrine, and their combination upon visceral fat mass and weight loss

Objective To evaluate the effects of combination caffeine/ephedrine and leptin A‐200 on visceral fat mass and weight loss over 24 weeks. Design and Methods In this randomized, double‐blind, parallel‐arm trial, 90 obese subjects received one of the three treatments for 24 weeks: 200 mg caffeine/20 mg ephedrine t.i.d. (CE), leptin A‐200 (recombinant methionyl human Fc‐leptin, 20 mg q.d.) (L), or combination leptin A‐200 and caffeine/ephedrine (LCE). Outcomes included change in weight, visceral fat mass by computed tomography, lean mass and fat mass by dual energy X‐ray absorptiometry. Results Groups treated with CE and LCE lost significant amounts of weight (−5.9 ± 1.2% and −6.5 ± 1.1%, P < 0.05) and whole body fat mass (−9.6 ± 2.4% and −12.4 ± 2.3%, P < 0.05) compared to leptin only group. Only treatment with LCE significantly reduced visceral fat mass (−11.0 ± 3.3%, P < 0.05). There were no differences in lean mass between treatment groups. Conclusions Our study provides evidence that CE is a modestly effective weight loss agent and produces significant reductions in fat mass. Leptin A‐200 was not effective in producing weight loss and did not have any significant additive or synergistic actions when combined with CE.