Combination of Soy Isoflavones, 8-Prenylnaringenin and Melatonin Improves Hot Flashes and Health-Related Quality of Life Outcomes in Postmenopausal Women: Flavie Study.
Study Goal
The researchers aimed to investigate the effects of a combination of soy isoflavones, 8-PN, and melatonin on reducing hot flashes and improving quality of life in postmenopausal women.
Results Summary
The study found significant improvements in quality of life scores and reductions in hot flashes at 4 and 12 weeks, with progressive benefits over time. The supplement combination effectively improved vasomotor, psychosocial, and physical domains.
Population
Postmenopausal women suffering from moderate-to-severe hot flashes (≥5 daily or ≥35 weekly).
Effective Dosage
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | vasomotor domain of MENQoL questionnaire | postmenopausal women suffering from moderate-to-severe hot flashes | 41.2% | significantly improved | #1 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | psychosocial domain of MENQoL questionnaire | postmenopausal women suffering from moderate-to-severe hot flashes | 26.3% | significantly improved | #2 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | physical domain of MENQoL questionnaire | postmenopausal women suffering from moderate-to-severe hot flashes | 25.0% | significantly improved | #3 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | menopause domain of the Cervantes Scale | postmenopausal women suffering from moderate-to-severe hot flashes | 39.3% | significantly increased | #4 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | psychic domain of the Cervantes Scale | postmenopausal women suffering from moderate-to-severe hot flashes | 51.7% | significantly increased | #5 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | global score of the Cervantes Scale | postmenopausal women suffering from moderate-to-severe hot flashes | 18.6% | significantly increased | #6 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | increase | global score of the Cervantes Scale | postmenopausal women suffering from moderate-to-severe hot flashes | 35.4% | significantly increased | #7 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | decrease | moderate-to-severe hot flashes | postmenopausal women suffering from moderate-to-severe hot flashes | 41.7% reduction | significantly decreased | #8 |
54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks | decrease | moderate-to-severe hot flashes | postmenopausal women suffering from moderate-to-severe hot flashes | 76.5% | further reduced | #9 |
Food supplements containing soy isoflavones, 8-PN, and melatonin | decrease | clinically significant hot flashes | postmenopausal women | - | showed an early and progressive benefit for reducing | #10 |
Food supplements containing soy isoflavones, 8-PN, and melatonin | increase | health-related quality of life across all domains | postmenopausal women | - | improving | #11 |
OBJECTIVES: This study aims to investigate the effects of a combination of soy isoflavones, 8-prenylnaringenin (8-PN), and melatonin in postmenopausal women suffering from moderate-to-severe hot flashes (HFs). METHODS: A multicenter, prospective, open-label study enrolled 44 postmenopausal women suffering from moderate-to-severe HFs (≥ 5 daily or ≥ 35 weekly) to receive 54.4 mg standardized soy isoflavones (including 24.5 mg genistein and 16.3 mg daidzein), 100 µg 8-PN, and 1 mg melatonin once daily for 12 weeks. The primary clinical outcomes included changes in health-related quality of life (HRQoL) scores (Menopause-Specific QoL questionnaire [MENQoL] and Cervantes Scale) and HFs following 4 and 12 weeks of treatment. Other analyses included treatment adherence, acceptability, tolerability, and safety. RESULTS: All of the four domains of MENQoL questionnaire significantly improved at 4 weeks (P < 0.05) and 12 weeks (P < 0.001), affecting significantly the vasomotor, psychosocial, and physical spheres (41.2%, 26.3%, and 25.0%; 12 weeks improvements, respectively). Similarly, in the menopause (39.3%) and psychic (51.7%) domains (both P < 0.05 at 12 weeks), the global score of the Cervantes Scale significantly increased at 4 weeks (18.6%) and 12 weeks (35.4%). Accordingly, moderate-to-severe HFs significantly decreased at 4 weeks compared to baseline (41.7% reduction) and further reduced at 12 weeks (76.5%), including the total number of episodes. CONCLUSIONS: Food supplements containing soy isoflavones, 8-PN, and melatonin showed an early and progressive benefit for reducing clinically significant HFs and for improving HRQoL across all domains, favorably affecting postmenopausal women's overall well-being.