Nutrients 2023 , 15 , 3466
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reduction observed at week 12 for the LPHEAL9 group and at week 8 for the placebo group with no significant differences between the groups (Table S1). Normally the cortisol levels increase in the morning, but for about 38% of the subjects, the cortisol level did not increase over 2.5 nmol/L at the baseline measurement (non-responders). Performing the analysis including only the responders did not change the results. Only looking at the first sample taken after the subject woke up (T0-sample) showed that the salivary cortisol level was significantly reduced at week 12 compared with baseline in the LPHEAL9 group ( p =0.039) but not in the placebo group ( p =0.525). 3.3. Mood and Quality of Sleep Mood was evaluated by the Profile of Mood States (POMS) questionnaire. The mean total mood disturbance score was 20.5 at baseline for the LPHEAL9 group and 18.4 for the placebo group (NS difference) (Table S2). For both groups, the mean total mood score reduced significantly over time, i.e., showed improved mood, and at week 12, the groups had mean scores of 9.1 and 10.6, respectively ( p = 0.161 between groups). All seven subscales improved significantly in the LPHEAL9 group after 12 weeks, while in the placebo group, three of the subscales did not change over the course of the study (Confusion–Bewilderment, Depression–Dejection, and Friendliness). For one of the sub scales, Confusion–Bewilderment, there was a trend for benefitting from LPHEAL9 con- sumption (mean change from baseline to week 12: − 1.63) compared to placebo consump- tion ( − 0.47, p = 0.051). In addition, for two of the mood subscales, Anger–Hostility and Depression–Dejection, there were trends for interaction between time and group, with an overall favor of LPHEAL9 vs. placebo (mixed ANOVA, p = 0.086 and p = 0.088, re- spectively). For Anger–Hostility, the score reduced equally in both groups at week 4, but at weeks 8 and 12, a larger decrease in the LPHEAL9 group was observed ( p =0.072 between groups at week 8). The scores for Depression–Dejection behaved in a similar way with larger reductions seen at week 8 ( p = 0.079 between groups) and at week 12 for the LPHEAL9 group. The quality of sleep was evaluated using the questionnaire Pittsburg Sleep Quality Index (PSQI). The PSQI total score reduced significantly over time in both groups and no difference between the groups was observed (Table S3). The PSQI total score can be divided into good sleep (score ≤ 5) or poor sleep (score > 5). At baseline, 55% of the subjects in the LPHEAL9 group and 61% in the placebo group had poor sleep (NS difference between groups). The percentage of subjects having poor sleep decreased over time, with a tendency of improved sleep in the LPHEAL9 group vs. placebo group. At week 8, the corresponding figures were 28% and 44%, respectively ( p = 0.069 between groups), and at week 12, 29% and 44%, respectively ( p = 0.087 between groups) (Chi-square analysis). The subscales of the PSQI showed a significantly improved overall sleep quality only within the LPHEAL9 group ( p = 0.037), while no difference was seen in the placebo group. There was also a significant improvement in daytime dysfunction within the LPHEAL9 group ( p <0.001), and a trend for an improvement in the placebo group ( p =0.052). 3.4. Cognition Six cognition tests were conducted at baseline and after 12 weeks of intervention. For two of these tests, all subjects scored high already at baseline and only minor changes over time were observed (Four Choice Reaction time and Computerised Corsi block; results not presented). For the other four tests, differences between the groups were measured (Table S4). A significant effect of LPHEAL9 on short-term memory was observed in the word recall test (Figure 3). The mean % accuracy increased significantly in the LPHEAL9 group from 42.8 at baseline to 49.3% after 12 weeks ( p = 0.003, ITT population). In contrast, the mean % accuracy decreased in the placebo group from 46.35 to 43.65% and a significant difference between the groups was observed ( p < 0.001) in both the ITT and PP population.
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