Franny Jongbloed

186 CHAPTER 7 up in a list of the service deliverables provided by Brainshake (http://www.brainshake. fi/ service-deliverables-web-v1_0) 31 . A schematic overview of all of the parameters and measurements, as well as the experimental timeline, is shown in Figure S2. Randomization Randomization was performed using computer-generated lists, which were printed out and put into opaque envelopes by an employee not involved in the study. The first 30 sequential numbers of each group ( i.e. , kidney donors and morbidly obese patients) where generated at once. Sequential numbers for the two groups were distinguishable. After these blocks, the total number of dropouts was randomized in one block by the same procedure. The coordinating investigator approached patients eligible for the study at the hospitals’ outpatient clinic during their scheduled doctor appointments. Allocation occurred after informed consent was given. All participants randomized to either the restricted diet or the DER-diet were blinded to which diet they received. Statistical analysis Categorical data are presented as numbers (percentage) and continuous variables as mean (SD/normal distribution) or median (interquartile distance/no normal distribution). The data were tested for normality using the Shapiro–Wilks test and visual assessment. Continuous data were compared using either the non-parametric Mann-Whitney test or the t-test for parametric data. Related samples were analyzed using the non-parametric Wilcoxon signed rank test. Semi-quantitative scoring of the questionnaires was performed via the paired t-test. Significance was set at P< 0.05. A Bonferroni correction for multiple testing was performed on the metabolic parameters. A P- value of ≤0.002 was considered significant. The analyses were performed using Statistical Packages for Social Sciences 21.0 (SPSS Inc., Chicago, IL, USA), GraphPad Prism (GraphPad Software Inc., La Jolla, CA, USA, version 5.01), and Office Excel (2010). This study was designed as a pilot study and therefore no power calculations were performed.