Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial
Received 28 June 2016
Accepted for publication 23 August 2016
Published 11 October 2016 Volume 2016:8 Pages 581—587
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Leyla Bahar
Peer reviewer comments 3
Editor who approved publication: Professor Elie Al-Chaer
Valentina Trimarco,1 Francesco Rozza,2 Raffaele Izzo,3 Vincenzo De Leo,4 Valentina Cappelli,4 Carla Riccardi,1 Costantino Di Carlo1
1Department of Neuroscience, Reproductive Sciences and Dentistry, 2Department of Biomedical Sciences, 3Department of Translational Medical Sciences, Federico II University of Naples, Naples, 4Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy
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: menopause, hot flushes, lipid profile, cholesterol, phytoestrogens, soy isoflavones, cardiovascular risk
This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.Download Article [PDF] View Full Text [HTML][Machine readable]