Single group, open-­‐label, pilot study of weight loss formula designed to improve body composition by facilitating loss of body fat without concomitant loss of fat-­‐free mass

Abstract

Efficacy and safety of a weight-­‐loss formula (LeanSpa, Orange, CT) designed to increase metabolism, improve appetite, and influence hormonal balance positively in order to deplete excess body fat while preserving fat-­‐free mass (FFM) and bone mineral density (BMD) was assessed in an open-­‐label, single-­‐group study. This was performed using conditions that closely resembled those under which consumers would most likely use the formula. The formula consisted of chromium, 5-­‐hydroxytryptophan, iodine, natural caffeine, octopamine HCL and extracts of Garcinia cambogia, green tea, and acai berry. Efficacy, assessed in 20 over-­‐weight adults enrolled in a 60-­‐day regimen, focused on changes in dual energy x-­‐ ray absorptiometry-­‐-­‐derived body composition and resting metabolic rates (RMR). Safety was assessed by analyses of a 40-­‐item clinical chemistry panel, vital signs, and daily tracking reports of appetite control, adverse events, and self-­‐reported quality of life. Over two-­‐months, subjects lost an average of 3.8 lbs of body fat (P <0.0003) while gaining 1.3 lbs of fat-­‐free mass (FFM) (P=0.054). BMD increased, but statistical significance was not reached. Total % body fat was reduced -­‐1.7% (P=0.0017); and abdominal fat, by -­‐1.7% (P=0.0035). At mid-­‐study, RMR increased 7.5% (P=0.0165) and remained elevated until the end. While self-­‐reported appetite control increased from baseline to end of study (P=0.042), no significant changes were found in blood pressure, resting heart rate, and daily self-­‐ratings of adverse/positive effects. These results suggest the potential for formulas designed to have a multi-­‐ mechanistic effects (increase metabolism, aid eating control, better hormonal balance) to improve body composition by facilitating loss of excess body fat without concomitant adverse effects on FFM and BMD.

KEY WORDS: Weight Loss; Body Composition; Body Composition Improvement Index (BCI); Fat Loss; Fat-­‐Free Mass; Bone Mineral Density; Resting Metabolic Rate; Eating Control; Multi-­‐Mechanistic Approach