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Effects of a New Combination of Nutraceuticals on Postmenopausal Symptoms and Metabolic Profile: A Crossover, Randomized, Double-Blind Trial

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Effects of a New Combination of Nutraceuticals on Postmenopausal Symptoms and Metabolic Profile: A Crossover, Randomized, Double-Blind Trial

Valentina Trimarco et al. Int J Womens Health.

Abstract

Objectives: This study was designed to measure the beneficial effects of a combination of nutraceutics (NUT; AkP04, Morestril®, Akademy Pharma) containing soy isoflavones (80 mg), dry extract of Angelica sinensis (50 mg), dry extract of Morus alba leaf (200 mg) and magnesium (56.25 mg) in the relief of somatic, psychological, and urogenital symptoms in postmenopausal patients, using the validated Menopause Rating Scale (MRS) and cardiovascular risk factors.

Materials and methods: A total of 43 symptomatic postmenopausal women (MRS ≥20) were enrolled in a crossover trial. After a 2-week run-in period, patients were randomized into two arms. One arm received probiotics plus placebo over 4 weeks, followed by a 4-week treatment with probiotics plus NUT. The second arm received probiotics plus NUT for 4 weeks, followed by a 4-week treatment with probiotics plus placebo.

Results: After the NUT period, participants showed a significant reduction in MRS score (18.4±5.4) in comparison to baseline (28.4±5) and the placebo period (28±5.2) (P<0.0001 for both comparisons). Furthermore, at the end of the active-treatment period, we observed a significant reduction in triglycerides, total and low-density lipoprotein cholesterol plasma levels and an increase in high-density lipoprotein cholesterol plasma concentration versus baseline and versus placebo (all P<0.04). Moreover, during the NUT period, we detected a significant reduction in diastolic blood pressure in comparison to baseline, but not in comparison to the placebo period.

Conclusion: This NUT combination was effective for the relief of menopause symptoms in postmenopausal patients and improved their cardiovascular risk profile.

Keywords: cardiovascular risk; cholesterol; hot flushes; lipid profile; menopause; phytoestrogens; soy isoflavones.

Conflict of interest statement

The abstract of this paper was presented at the 14th National Congress of the Italian Society of Cardiovascular Prevention (SIPREC), Naples, March 17–19, 2016 as a poster presentation with interim findings. It was published in High Blood Pressure & Cardiovascular Prevention (2016;23[2]:155–174). The authors report no conflicts of interest in this work.

Figures

Figure 1
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.
Figure 2
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.

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