Nutrients 2023 , 15 , 2688
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3.5. Antropometrics, Physical Activity, Dietary Intake and Health-Related Quality of Life No significant differences between groups were observed for anthropometric parame- ters at any visit (Table S6). Physical activity assessed using the PASE questionnaire showed similar activity at baseline and throughout the 48 weeks between the HE and placebo groups (Table S7). Dietary analysis using the FFQ showed both groups had similar intake at baseline. After 48 weeks, the HE group showed higher fat, calcium, and vitamin K 2 intakes, compared to the placebo group ( p < 0.05; Table S7). For fat, the median change from placebo at week 48 was + 11 g/d, for calcium +112 mg/d, and for vitamin K 2 +2.3 µ g/d in the HE group compared to the placebo group. Changes in SF-36 scores after 48 weeks are shown in Table 2. The physical functioning score was significantly increased in the HE group compared to the placebo group ( p <0.05), with 25 participants (53%) showing increased scores (>0) in the HE group compared to 14 (30%) in the placebo group. The role limitations due to physical health score trended toward a greater increase in the HE group compared to placebo ( p = 0.08); however, at least 50% of the participants had no change in both groups (Q1; Q3 changes from baseline = 0; 0), and only eight and five participants had increased scores in the HE and placebo group, respectively, indicating a weak effect. No difference between groups was observed for the other scores.
Table2. Health-related quality of life.
SF-36 Scores
Statistics
HE ( n =50)
Placebo ( n =47)
p
Physical functioning
median (Q1; Q3) median (Q1; Q3)
5 (0; 10) 0 (0; 0) 0 (0; 0)
0 (0; 5) 0 (0; 0) 0 (0; 0)
0.049 0.082 0.589 0.914 0.530 0.555 0.969 0.407
Role limitations due to physical health
Role limitations due to emotional problems median (Q1; Q3)
Energy/fatigue
mean (SD)
2.66 (11.7) 0 ( − 4; 8) 0 (0; 0) 1.01 (18.96) 2.77 (10.67)
1.6 (12.69) 0 ( − 4; 4) 0 (0; 0) 1.06 (23.06) − 0.43 (14.74)
Emotional well-being Social functioning
median (Q1; Q3) median (Q1; Q3)
Pain
mean (SD) mean (SD)
General health
3.6. Gut Microbiome Modulation As the gut microbiota is a key player in prenylflavonoid metabolism and bone home- ostasis, potential differences in the microbiome composition between the HE and placebo groups were explored. Low-dimensional representations of the taxonomic profiles com- puted using non-metric multidimensional scaling (MDS) on Bray–Curtis and Jaccard β -diversity scores suggested that there were no differences between the groups at any visit. These exploratory results were also confirmed with MiRKAT overall association tests based on β -diversity (Figure S1). There was also no significant difference between groups in terms of α -diversity assessed as change from baseline by the inverse Simpson index, Shannon index, and observed number of species (Figure S2). Despite this lack of significant differences between the overall compositions of samples between the HE and placebo groups, an exploratory multivariate analysis was run to identify the taxa that seem more relevant to distinguish between the two groups. Results for each taxonomic rank (family, genus, specie) are displayed in Figure 3. Results shown in Figure 3A highlight five families enriched in the HE group and seven enriched in the placebo group. The most discriminant family to differentiate between the two groups was Barnesiellaceae, which was more abundant in the HE group. Observed prevalence, however, was high and roughly the same in both groups. Turicibacteraceae was also enriched in the HE group, showing larger mean abundance and prevalence than in the placebo group. This finding was consistent with the identification of Turicibacter as a differentiating genus more abundant and prevalent in the HE group. To be noted, Turicibacter was also identified as one of the most discriminant genus to differentiate between the two groups after 24 weeks, being more abundant and prevalent in the HE group compared to the placebo group such as after 48 weeks (Figure S3). Shigella was also
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