title: Effects of a new combination of nutraceuticals on postmenopausal symptoms and metabolic profile: a crossover, randomized, double-blind trial.
abstract: OBJECTIVE
  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 ofAngelica sinensis(50 mg), dry extract ofMorus albaleaf (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.
  
  
  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 (allP<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.
  
  
  CONCLUSIONS
  This NUT combination was effective for the relief of menopause symptoms in postmenopausal patients and improved their cardiovascular risk profile.
authors: Department of Neuroscience, Reproductive Sciences and Dentistry.
authors: Valentina
authors: V
authors: Trimarco
authors: Department of Biomedical Sciences.
authors: Francesco
authors: F
authors: Rozza
authors: Department of Translational Medical Sciences, Federico II University of Naples, Naples.
authors: Raffaele
authors: R
authors: Izzo
authors: Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.
authors: Vincenzo
authors: V
authors: De Leo
authors: Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy.
authors: Valentina
authors: V
authors: Cappelli
authors: Department of Neuroscience, Reproductive Sciences and Dentistry.
authors: Carla
authors: C
authors: Riccardi
authors: Department of Neuroscience, Reproductive Sciences and Dentistry.
authors: Costantino
authors: C
authors: Di Carlo
keywords: cardiovascular risk; cholesterol; hot flushes; lipid profile; menopause; phytoestrogens; soy isoflavones