Nutrients 2023 , 15 , 2688 Nutrients 2023 , 15 , x FOR PEER REVIEW
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Figure 2. Relative changes from baseline at week 48 of BMD at L2-L4 lumbar spine and total body ( A ); percentage of women with a total body BMD change from baseline at week 48 ≥ 1% ( B ); sub- group analysis with relative changes from baseline at week 48 of BMD at L2-L4 lumbar spine and total body in vitamin D su ffi cient vs. insu ffi cient women at baseline ( C ). All data are represented as mean ± SEM. # Odds ratio for relative change from baseline (probability modeled for class ≥ 1%) (HE vs. Placebo) (95% CI): 2.41 (1.01; 5.74), p < 0.05. * p = 0.05 versus placebo. 3.4. Biochemical Analysis No signi fi cant di ff erences were observed between the HE and placebo groups after 48 weeks of supplementation for any of the plasma bone biomarkers measured (Table S5). Compared to baseline, CTx level increased after 48 weeks in both groups ( p < 0.001), while sclerostin and TRAP5b decreased in both groups ( p < 0.05). uOC decreased signi fi cantly in the HE group after 48 weeks ( p < 0.01). Similarly, no signi fi cant di ff erences between groups were observed at 48 weeks for the following blood parameters: triglycerides, total cholesterol, HDL-cholesterol, LDL- cholesterol, fasting glucose, insulinemia, HbA1c, HOMA-IR, serum 25-OH D3 concentra- tion, and 17- β oestradiol (Table S6). 3.5. Antropometrics, Physical Activity, Dietary Intake and Health-Related Quality of Life No signi fi cant di ff erences between groups were observed for anthropometric param- eters 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 pla- cebo 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, com- pared 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 µg/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 signi fi cantly 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 Similarly, no significant differences between groups were observed at 48 weeks for the following blood parameters: triglycerides, total cholesterol, HDL-cholesterol, LDL- cholesterol, fasting glucose, insulinemia, HbA1c, HOMA-IR, serum 25-OH D3 concentra- tion, and 17- β oestradiol (Table S6). Additionally, post hoc sub-group analysis was performed according to vitamin D status (sufficient if ≥ 75 nmol/L and insufficient if <75 nmol/L). In vitamin D suffi- cient women, there was an increase in the HE group compared to the placebo group for the BMD at L2-L4 lumbar spine (difference of adjusted relative changes from baseline ± SE=2.29 ± 1.16%; p = 0.051) and the total body BMD (difference of adjusted relative changes from baseline ± SE=1.44 ± 0.78%, p = 0.066; Figure 2C). 3.4. Biochemical Analysis No significant differences were observed between the HE and placebo groups after 48 weeks of supplementation for any of the plasma bone biomarkers measured (Table S5). Compared to baseline, CTx level increased after 48 weeks in both groups ( p < 0.001), while sclerostin and TRAP5b decreased in both groups ( p < 0.05). uOC decreased significantly in the HE group after 48 weeks ( p <0.01). Figure2. Relative changes from baseline at week 48 of BMD at L2-L4 lumbar spine and total body ( A ); percentage of women with a total body BMD change from baseline at week 48 ≥ 1%( B ); sub-group analysis with relative changes from baseline at week 48 of BMD at L2-L4 lumbar spine and total body in vitamin D sufficient vs. insufficient women at baseline ( C ). All data are represented as mean ± SEM. # Odds ratio for relative change from baseline (probability modeled for class ≥ 1%) (HE vs. Placebo) (95% CI): 2.41 (1.01; 5.74), p <0.05. * p = 0.05 versus placebo. Regarding body composition, lean mass and fat percentage were not modulated in any groups, while fat mass and visceral fat were significantly increased after 48 weeks compared to baseline in the HE group (median change (Q1; Q3) = 714.0 ( − 123.0; 1285.0) g for fat mass and 52.5 ( − 55.0; 213.0) g for visceral fat, p < 0.05), but no significant difference between groups was found.
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