Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial

Figures & data

Figure 1 Flowchart of the study.

Note: *Seven participants were excluded on account of an MRS <20.
Abbreviations: PL, placebo; NUT, nutraceutics; SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MRS, Menopause Rating Scale.

Table 1 Baseline demographic and clinical characteristics of the study population divided by initial treatment

	Starting with probiotics + PL (n=22)	Starting with probiotics + NUT (n=21)	P-value
Age (years)	55.3±3.8	55.5±3.3	NS
SBP (mmHg)	130.8±17.2	121.8±11.8	NS
DBP (mmHg)	78.8±5.7	76.1±6.5	NS
Waist circumference (cm)	88.4±13	89.1±14.7	NS
Total cholesterol (mmol/L)	5.8±0.85	5.5±0.79	NS
HDL cholesterol (mmol/L)	1.5±0.38	1.52±0.33	NS
LDL cholesterol (mmol/L)	3.61±0.81	3.4±0.7	NS
Triglycerides (mmol/L)	1.5±0.64	1.3±0.64	NS
Fructosamine (μmol/L)	221.6±35.6	222.5±38.3	NS
MRS (score)	27.8±5.9	28.9±4	NS

Note: Each value represents mean ± SD.

Abbreviations: PL, placebo; NUT, nutraceutics; SBP, systolic blood pressure; DBP, diastolic blood pressure; HDL, high-density lipoprotein; LDL, low-density lipoprotein; MRS, Menopause Rating Scale; NS, not significant; SD, standard deviation.

Table 2 MRS score compared from baseline after first-line intervention and second-line intervention

	Second visit (% vs randomization visit)	Final visit (% vs second visit)
Starting with probiotic + PL (n=22)	0.4	−35.0
Starting with probiotic + NUT (n=21)	−31.0	−1.3

Notes: P=0.705 when comparing second visit of group starting with probiotic + PL versus final visit of group starting with probiotic + NUT; P=0.532 when comparing final visit of group starting with probiotic + PL versus second visit of group starting with probiotic + NUT.

Abbreviations: MRS, Menopause Rating Scale; PL, placebo; NUT, nutraceutics.

Figure 2 MRS score after placebo and NUT period.

Note: Data obtained with active treatment and placebo were cumulated for the statistical analysis.
Abbreviations: MRS, Menopause Rating Scale; NUT, nutraceutics.

Table 3 MRS divided into different categories of menopausal symptoms at baseline and at the end of the two study periods

	Baseline (n=43)	Placebo (n=43)	NUT combination (n=43)	P< (placebo vs baseline)	P< (NUT vs baseline)	P< (NUT vs placebo)
Urogenital symptoms	6.5±1.9	6.9±1.8	4.9±1.9	NS	0.0001	0.0001
Psychological symptoms	13.4±2.9	12.8±3.4	8.2±2.8	NS	0.0001	0.0001
Somatovegetative symptoms	8.4±1.9	8.0±2.2	5.4±1.9	NS	0.0001	0.0001

Note: Each value represents mean ± SD.

Abbreviations: MRS, Menopause Rating Scale; NUT, nutraceutics; NS, not significant; SD, standard deviation.

Table 4 Blood pressure, lipid, and glucose profile at baseline and at the end of the two study periods

	Baseline (n=43)	Placebo (n=43)	NUT combination	P< (placebo vs baseline)	P< (NUT vs baseline)	P< (NUT vs placebo)
SBP (mmHg)	126.2±15.2	128.4±13	126.4±10.3	NS	NS	NS
DBP (mmHg)	77.5±6.3	76.3±6	74.6±6.6	NS	0.026	NS
Waist circumference (cm)	88.7±13.8	88.9±13.8	88.3±13.5	NS	NS	NS
Total cholesterol (mmol/L)	5.7±0.83	5.6±0.76	4.9±0.71	NS	0.0001	0.0001
HDL cholesterol (mmol/L)	1.5±0.35	1.5±0.33	1.6±0.37	NS	0.0001	0.01
LDL cholesterol (mmol/L)	3.5±0.76	3.5±0.77	2.8±0.69	NS	0.0001	0.0001
Triglycerides (mmol/L)	1.4±0.65	1.3±0.57	1.2±0.43	NS	0.016	0.036
Fructosamine (μmol/L)	222.0±36.6	219.6±31.5	210.9±34.4	NS	NS	NS

Note: Each value represents mean ± SD.

Abbreviations: NUT, nutraceutics; SBP, systolic blood pressure; DBP, diastolic blood pressure; HDL, high-density lipoprotein; LDL, low-density lipoprotein; NS, not significant; SD, standard deviation.