Table 1. Demographic data and baseline clinical and analytical characteristics.
| Control – ViveSoy® | ViveSoy® – control | p values | |
|---|---|---|---|
| Demographic data | |||
| Age (years); mean (SD) | 51.5 (3.5) | 51.8 (3.1) | 0.5665 |
| Weight (kg); mean (SD) | 64.8 (9.1) | 65.4 (10.7) | 0.9822 |
| Anthropometric measurements | |||
| BMI; mean (SD) | 25.55 (3.22) | 26.70 (4.26) | 0.3617 |
| Overweight or obese patients; n (%) | 26 (57.8) | 24 (53.3) | 0.6714 |
| Neck circumference (cm); mean (SD) | 32.8 (1.8) | 33.6 (2.6) | 0.0750 |
| Waist circumference (cm); mean (SD) | 83.0 (9.4) | 87.0 (12.2) | 0.0997 |
| Hip circumference (cm); mean (SD) | 100.5 (8.4) | 101.6 (10.5) | 0.6931 |
| Body fat (%); mean (SD) | 38.4 (4.4) | 40.2 (5.4) | 0.1145 |
| Lifestyle and habits | |||
| Smoking | 0.5749 | ||
| Ex-smoker for less than 5 years; n (%) | 1 (2.2) | 3 (6.7) | |
| Smoker (at least 1 cigarette in the last month); n (%) | 15 (33.3) | 12 (26.7) | |
| Non-smoker/Ex-smoker for at least 5 years; n (%) | 29 (64.4) | 30 (66.7) | |
| Alcohol consumption (AU/week; mean (SD) | 0.3 (0.4) | 0.1 (0.3) | 0.1158 |
| Physical activity | 0.2244 | ||
| Vigorous; n (%) | 2 (4.4) | 1 (2.2) | |
| Light; n (%) | 21 (46.7) | 29 (64.4) | |
| Moderate; n (%) | 22 (48.9) | 15 (33.3) | |
| Energy expenditure (kcal/day); mean (SD) | 2148.77 (253.49) | 2135.48 (253.37) | 0.9039 |
| Clinical data | |||
| SBP (mmHg); mean (SD) | 120.5 (13.3) | 123.6 (14.1) | 0.4164 |
| DBP (mmHg); mean (SD) | 74.7 (9.1) | 77.3 (9.7) | 0.2607 |
| Heart rate (bpm.); mean (SD) | 71.8 (9.2) | 72.3 (8.4) | 0.6373 |
| Analytical data | |||
| Glucose (mg/dL); mean (SD) | 88.8 (8.4) | 89.6 (9.7) | 0.5302 |
| Cholesterol (mg/dL); mean (SD) | 233.5 (33.1) | 241.6 (31.6) | 0.2788 |
| Triglycerides (mg/dL); mean (SD) | 98.3 (53.2) | 104.9 (48.1) | 0.2307 |
| HDL Cholesterol (mg/dL); mean (SD) | 66.4 (15.2) | 64.4 (11.7) | 0.7111 |
| LDL Cholesterol (mg/dL); mean (SD) | 147.5 (29.7) | 156.1 (29.3) | 0.1930 |
| Hemoglobin A1c (%); mean (SD) | 5.51 (0.28) | 5.43 (0.37) | 0.0985 |
| Hemoglobin A1C (mmol/mol); mean (SD) | 36.9 (3.1) | 35.8 (4.1) | 0.0985 |
| C-reactive protein (mg/L); mean (SD) | 2.37 (4.14) | 2.66 (3.41) | 0.9519 |
| Atherogenic index; mean (SD) | 3.67 (0.88) | 3.87 (0.84) | 0.2182 |
| Total cholesterol > 200 mg/dL; n (%) | 37 (82.2) | 38 (84.4) | 1.0000 |
| LDL cholesterol > 100 mg/dL; n (%) | 42 (93.3) | 45 (100.0) | 0.2416 |
| HDL cholesterol < 40 mg/dL; n (%) | 0 | 0 | - |
| Triglycerides > 150 mg/dL; n (%) | 5 (11.1) | 6 (13.3) | 1.0000 |
| Cardiovascular risk | |||
| SCORE score; mean (SD) | 0.52 (0.44) | 0.56 (0.38) | 0.5680 |
| Bone metabolism | |||
| BAP | 11.50 (4.19) | 11.55 (3.73) | 0.6653 |
| MRS questionnaire | |||
| Total score; mean (SD) | 15.7 (6.9) | 15.8 (7.5) | 0.9836 |
| Symptoms subscale; mean (SD) | 7.1 (2.5) | 7.2 (2.7) | 0.7736 |
| Psychological subscale; mean (SD) | 5.5 (3.6) | 5.8 (3.5) | 0.4025 |
| Urogenital subscale; mean (SD) | 3.2 (2.3) | 2.7 (2.8) | 0.1579 |
| SF-12 quality of life questionnaire | |||
| Mental health component (MCS); mean (SD) | 45.56 (9.65) | 43.07 (10.86) | 0.3664 |
| Physical health component (PCS); mean (SD) | 46.81 (10.39) | 45.00 (10.26) | 0.2202 |
MRS, Menopause Rating Scale; BMI, body mass index; SBP, systolic blood pressure; DBP, diastolic blood pressure; BAP, Bone alkaline phosphatase.