Effects of a leucine and pyridoxine-containing nutraceutical on body weight and composition in obese subjects

Background: We recently demonstrated leucine to modulate energy partitioning between adipose tissue and muscle. Further, leucine exhibits a synergy with B6, resulting in reduced adipocyte lipid storage coupled with increased muscle fat oxidation. Accordingly, a nutraceutical (NuShape (TM)) containing 2.25 g leucine and 30 mg B6 increased fat oxidation by >30 g/day in a 28-day randomized controlled trial. The present study evaluated the long-term efficacy of this combination in modulating body weight and composition. Methods: Two 24-week, placebo-controlled, randomized trials, one with weight maintenance (n = 20) and one hypocaloric (-500 kcal/day; n = 24), were conducted using the nutraceutical Nushape in obese subjects. Results: The supplement resulted in fat loss in the maintenance study (-1.12 +/- 0.36 and -1.82 +/- 0.70 kg at 12 and 24 weeks, P < 0.01 versus placebo) while no change was found in the placebo group. In the hypocaloric study, the supplement group lost up to twice as much weight (6.18 +/- 1.02 versus 3.40 +/- 0.81 kg at 12 weeks and 8.15 +/- 1.33 versus 5.25 +/- 1.13 kg at 24 weeks, P < 0.01) and fat (4.96 +/- 0.61 versus 2.31 +/- 0.53 kg at 12 weeks and 7.00 +/- 0.95 versus 4.22 +/- 0.74 kg at 24 weeks, P < 0.01) than the placebo group. Conclusion: This nutraceutical combination results in significant fat loss in the absence of caloric restriction and markedly enhances weight and fat loss by 50%-80% over a 24-week period.