Impact of a soy drink on climacteric symptoms: an open-label, crossover, randomized clinical trial

Figures & data

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.

Figure 1. Changes in climacteric symptoms (symptoms subscale on the MRS questionnaire, items 1, 2, 3, and 11).

Figure 2. Changes in total score on the MRS questionnaire.