The effect of 7-Keto Naturalean™ on weight loss:: A randomized, double-blind, placebo-controlled trial

Background: A natural metabolite of dehydroepiandrosterone (DHEA), 3-acetyl-7-oxo-dehydroepiandrosterone (7-oxo-DHEA), has been shown to be effective in enhancing weight loss when combined with a diet and exercise program. Objective: This study assessed the effects of a formula containing 7-oxo-DHEA, L-tyrosine, asparagus root extract, choline bitartrate, inositol, copper gluconate, manganese, and potassium iodide (7-Keto Naturalean(TM)) on weight loss, body composition, and basal metabolic rate (BMR) in overweight patients following a weight-reduction diet and exercise regimen. Methods: In this prospective, randomized, double-blind, placebo-controlled trial, healthy, overweight adults were given 7-Keto Naturalean (200 mg/d) or a placebo of maltodextrin and followed a calorie-restricted diet (105 kJ/kg) and an exercise program for 8 weeks. Body weight, body composition (by bioelectric impedance), and BMR (by indirect calorimetry) were measured at baseline, week 4, and week 8. A thyroid panel was done at baseline and week 8. Results: Of 35 healthy, overweight adults enrolled, 33 completed the study (12 men, 21 women; age, 40-69 years; body mass index [BMI], 27.0-42.7 kg/m(2)). Patients taking 7-Keto Naturalean lost significantly more weight after 8 weeks than those taking placebo (mean +/- SD loss, 2.15 +/- 2.38 kg and 0.72 +/- 2.12 kg, respectively) (P = 0.038). The change in BMI in the 7-Keto Naturalean-treated group was significant compared with the change in the placebo group (mean +/- SD decrease, 0.71 +/- 0.79 kg/m(2) and 0.01 +/- 1.05 kg/m(2), respectively) (P = 0.036). There were no other statistically significant differences in any of the other measured variables. 7-Keto Naturalean was well tolerated, and there were no significant adverse events. Conclusion: In this select population, 7-Keto Naturalean combined with a reduced-calorie diet and an exercise program resulted in a significant weight loss compared with diet and exercise alone.