Outcomes and assessments
SECONDARY
The primary outcome of the current randomized clinical trial (RCT) was the changes in some kidney function parameters, and the secondary outcomes were changes in PAB, glycemic status, quality of life, and BP from baseline to the end of the intervention.The socio-demographic questionnaire was filled by an interview in the first visit. Anthropometric parameters such as weight and height were assessed by validated tools at the baseline and the end of the trial. Weight was measured with light clothes and no shoes, close to 100 g, by a digital Seca scale (Seca 22089, Hamburg, Germany). Height was measured using a portable stadiometer (Seca, Hamburg, Germany), in a straight standing position and without shoes, close to 0.5 cm. Then, BMI was calculated by dividing weight in kilograms by height in meters squared. At the end of each medical appointment, BP was measured using a mercury sphygmomanometer (ALPK2, Japan). 10 mL of blood sample was obtained from each participant after 12 h of overnight fasting at the commencement of the study and at the end of intervention. Samples were collected into the tubes containing ethylenediamine tetraacetic acid (EDTA) for Hemoglobin A1C (HbA1C) analysis and tubes without anticoagulant (for centrifugation and obtaining the serum). Separated serums were used to measure insulin (enzyme-linked immunosorbent assay (ELISA), Monobind), fasting blood sugar (FBS) (enzymatic-colorimetric, Mancompany), and creatinine (Jaffe, Parsazmun). The other aliquoted serum samples were frozen at − 20 °C for the PAB assay analysis (ELISA, Merck KGaA). Hemoglobin A1C (corrected-enzymatic, Biorexfars) was determined from whole blood samples. The 24-h urine samples were collected to measure volume and the protein content (Photometric, Parsazmun) at the baseline and the end of the study. All biochemical measurements except PAB were performed immediately after sampling. Pro-oxidant–antioxidant balance assay was done as described by Faraji-Rad et al.