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Fig. 1.a Chest circumference at axilla (CCA, 2), chest circumference at nipples (CCN, 3), waist circumference (WC, 4), hip circumference (HC, 5); b hip circumference oblique (HCO, 6).



As no parameters describing the change of the above mentioned circumferences per kg of weight lost have been found in the reviewed literature, new quotients of mean daily decrease of the circumferences for mean daily weight decrease (QNC, QCCA, QCCN, QWC, QHC, QHCO) were introduced. These parameters reflect the volume-to-weight change of the corresponding region. The ratios WHtR and WHR were also calculated [17].

In the context of clinical examination, systolic and diastolic blood pressure (SBP and DBP) were measured with a classical quicksilver apparatus (Focal no. FC113, Tokyo, Japan). Heart rate (HR) and hemoglobin oxygen saturation (SatO2) were measured with a pulse oxymeter (Bionics Palmcare, Seoul, Korea).

Serum K+, Na+, and Cl- ion concentrations were determined by ion selective electrodes (EasyLyte analyzer, Medica Corporation, Bedford, MA, USA). Serum urea, creatinine and glucose concentrations, and urine creatinine concentration were measured following standard laboratory methods (ABX Pentra, Horiba, Montpellier, France). Serum osmolality was measured by a cryoscopic osmometer (Osmomat 030 Gonotec, Berlin, Germany). Urine weight for each participant was calculated daily from urine volume and its specific gravity. Each participant noted the approximate weight of stools for all 5 days of FWD, and from these data the approximate mean daily stool discharge was calculated.

Anthropometric data and 24-hour urine volume are presented as additive mean change values per day. For the critical hemodynamic (SBP, DBP, HR, SatO2) and laboratory parameters (serum glucose, serum osmolality, K+, Na+, Cl-, urea, creatinine, creatinine clearance), the mean, maximum, and minimum values are presented, in order to show the degree of safety for each of the participants on a daily basis.

Statistical Analysis

Statistical analysis of data was carried out with the SPSS version 15.0.0 software package (Chicago, IL, USA). 2 nonparametric tests for correlated samples (Friedman and Wilcoxon tests) were used. The Friedman test was applied to all parameters and was used to detect differences from day 0 to day 5 of the intervention.

The parameters, for which cumulative values were used, were calculated as follows: Initially, for every participant the daily change of the relative anthropometric parameter was calculated by subtracting the daily value from the corresponding value of the previous day. Then, the mean daily change was calculated by adding all the daily change values and dividing the outcome by the number of participants. Finally, each mean change value was added to the sum of the predecessor mean values. Data are presented as mean additive change per day.

The minimum, maximum, and mean values for glucose, serum osmolality, K+, Na+, Cl-, urea, creatinine, creatinine clearance, SBP, DBP, HR, and SatO2 are presented for each day. The Friedman test was employed for all values from day 0 to day 5. Differences were considered significant, if the probability (pf) that occurred by chance was < 0.05. Furthermore, the Wilcoxon test was performed to compare the values of day 0 and day 5 and determine pw. For serum glucose, an additional comparison of the values on day 0 and day 3 was made and pw3 was determined. The significance level was regarded positive when pw < 0.05.