Weight management outcomes. Change in total body fat mass from baseline to end of study (6 months of intervention) in the Intention-to-Treat (a) and Per Protocol (PP) (b) populations. Evolution of body fat mass in the PP population during intervention and at follow-up (c). Changes in trunk fat mass (d), android fat mass (e), lean body mass (f), body weight (g), waist circumference (h) and hip circumference (i) from baseline to end of study in the PP population. Body composition in panels a-f was measured with dual-energy X-ray absorptiometry. Results are expressed as mean ± 95% CI. Results were analyzed with ANCOVA and Dunnett's pairwise comparisons corrected for multiple testing. In the ITT population, the last observation was carried forward for the statistical analysis of participants who withdrew from the study. Solid line shows baseline; dotted line shows the level of the Placebo group. N of participants included in the statistical analysis in the Intention-to-Treat population: Placebo n = 53, LU n = 51, B420 n = 47, LU + B420 n = 48. N for the PP population: Placebo n = 35–36, LU n = 35–36, B420 n = 24–25, LU + B420 n = 37. Overall ANCOVA as follows: a) P = 0.46, b) P = 0.095, d) P = 0.036, e) P = 0.23, f) P = 0.30, g) P = 0.13, h) P = 0.10, i) P = 0.31.