05, a standard deviation (SD) in percent change from baseline in fasting serum triglycerides of 25%, and 80% power, it was estimated that 60 subjects would be required per group, and 300 subjects would be required, in

total. However, a large degree of intra-individual selleck screening library variation was observed in the TG measurements, which were not accounted for in the power calculation. Thus, in addition to present the TG level changes after 6 and 12 weeks, the mean changes from baseline at 6 and 12 weeks in fasting TG in the four krill oil groups were pooled in a time- and dose-independent manner for comparison to the placebo group. By doing so, the statistical power was increased and the relative (%) changes from baseline in fasting TGs were compared using a Student’s t-test. However, the pooling approach can only be seen as explorative data analysis. The other lipid parameters (total cholesterol, LDL-C and HDL-C) were not associated with large intra-individual signaling pathway variability and were therefore compared to the

corresponding measures in the placebo group using an analysis of variance (ANOVA), without pooling the data points across the krill oil groups. The TG data presented in Table 4 was analyzed using ANOVA. The statistical analyses were performed in JMP 10.0.2 (SAS Institute, Cary, NC). Changes were considered statistically significant at p < 0.05. All data are presented as means ± SD, unless otherwise specified. A total of 300 subjects were randomized into five groups and were supplemented with either placebo (olive oil) or one of four krill oil doses (0.5, 1, 2 or 4 g/day) (Fig. 1). Altogether, data for 33 subjects were not included in the efficacy analysis. The average of the Screening and Day 0 TG values was used as baseline TG values. However,

twenty-four subjects had a fasting TG level within the range required for inclusion at screening (i.e., between 150 and 499 mg/dL, find more inclusive); and not at baseline, where the fasting TG levels were normal (i.e., <150 mg/dL). Data for these 24 subjects were excluded from the analysis. Of the other 9 subjects whose data were not included in the efficacy analysis, 1 subject was determined from the dietary records to consume fatty fish more than twice per month, 1 subject had adverse events (hypertension; not related to study product intake), 3 subjects withdrew from the study (two because of scheduling conflicts and one for personal reasons) and 4 subjects had major protocol deviations (all four were not fasted at blood sampling). Daily EPA and DHA doses are depicted in Table 2, as are the numbers of subjects that could be used for the efficacy assessments. More males (69%) than females participated in the study. Most subject characteristics at baseline were not significantly different between the groups. In particular mean fasting serum TG values at baseline, which were approximately 232 mg/dL, were similar between the groups.