27 Before and after diet serum high sensitive-C-reactive protein (CRP) (in μg/mL), total and high molecular weight adiponectin (both μg/mL), and fetuin-A (in ng/mL), were measured by sandwich enzyme-linked immunosorbent assay (ELISA) with the following characteristics: hs-CRP (BioVendor, Heidelberg, Germany; #RH961CRP01HR), intraassay coefficient of variation (CV) 3.8%, and interassay CV 5.2%. Adiponectin
(ALPCO Immunoassays, Salem, NH; #47-ADPHU-E01), intraassay CV between 5.1% and 9.8% for the different multimeres and interassay CV between 4.8% and 6.5%. Fetuin-A (BioVendor, Heidelberg, Germany; #RD191037100), intraassay CV 4.9% and interassay CV 5.7%. Transforming growth factor beta1 (TGF-β1) ELISA kits were purchased from Biovendor and used according this website to the manufacturer’s protocol. Samples were measured in duplicate. The intra- and interassay CVs for the ELISA were 5.1% and 8.4%, respectively. Soluble human intermediate filament protein fragments of cytokeratin 18 were measured with the M30-Apoptosense ELISA from Peviva AB (Bromma, Sweden) in strict accordance with the manufacturer’s protocol. Intraassay coefficient of variation
was 3.1% and interassay coefficient of variation was 5.2% in a pooled control plasma sample from our laboratory. The B-SMART study had the primary goal to compare weight loss with reduced fat and reduced carbohydrate hypocaloric eltoprazine diets. learn more Overall, we expected a 5%-10% weight loss from baseline within 6 months with a 3% greater body weight reduction from baseline in the reduced carbohydrate compared with the reduced fat group. The secondary goal was to examine associated cardiovascular and metabolic
markers. To allow for a meaningful analysis of these secondary goals, we included enough patients to have at least 50 patients in each group complete the 6-month weight loss phase. With 50 patients in each group, the study had a 95% statistical power to show a 3% difference in weight loss from baseline between groups (alpha = 0.05, two-sided). For changes in body weight, measured every month during diet, we additionally performed an intention to treat with last observation carried forward analysis. Because magnetic resonance imaging and spectroscopy was only conducted in patients finishing the 6-month weight loss phase, the statistical analysis is restricted to completers. No interim analysis was planned. Differences in the response to dietary interventions were analyzed using unpaired t tests. For subgroup analysis at baseline, we applied one-way analysis of variance (ANOVA) with Bonferroni post-hoc tests. To test for interactions between diet groups over the 6-month period (diet × time), we used a two-way ANOVA for repeated measures.