Figure 1.CONSORT diagramTwo hundred and thirty eight individuals were eligible and 220 individuals were randomized. Two individuals, both assigned to the calorie-restricted (CR) group, dropped out prior to starting the intervention, resulting in an intention-to-treat cohort of 218 participants; 75 in the ad libitum (AL) control and 143 in the CR group (Table 1). Thirty participants were withdrawn or dropped from the intervention prior to completion including 4 (5.3%) in the AL control group and 26 (18.2%) in the CR group (p=0.01).
