FLAVOCAV Trial

Research Hypothesis
Our primary hypothesis was that daily supplementation with 80 mg of soy isoflavones would significantly improve quality of life in menopausal women, as measured by the Menopause-Specific Quality of Life (MENQOL) questionnaire, without adversely affecting coagulation markers (D-dimer and platelet counts).

Data and Methodology
Data were gathered through a parallel-group, double-blind, randomized controlled trial. One hundred postmenopausal women (12+ months amenorrhea) aged 45–65 were randomized to receive either soy isoflavones (80 mg/day) or a matching multivitamin placebo for 180 days. The MENQOL questionnaire (a validated 35-item instrument) was administered, and venous blood samples were collected to measure D-dimer, platelets, total cholesterol, and glucose at baseline, 90 days, and 180 days. Statistical analyses included repeated-measures ANOVA and t-tests, with intention-to-treat analysis.

Key Findings
Quality of Life: A significant improvement in total MENQOL score was observed in the intervention group at 180 days (104.9 ± 7.5 vs. 98.7 ± 9.1 in placebo; p = 0.0008).

Coagulation Markers: No significant changes were found in D-dimer (p = 0.371) or platelet levels (p = 0.164) between groups over time.

Safety: No adverse events or changes in clinical parameters (e.g., blood pressure, heart rate) were attributable to the intervention.

Interpretation
The data support the hypothesis: soy isoflavones significantly enhanced menopausal quality of life without affecting coagulation pathways. This suggests that soy isoflavones are a safe and effective non-hormonal alternative for alleviating menopausal symptoms, particularly in women seeking options beyond hormone therapy. Researchers and clinicians can use these findings to recommend soy isoflavones for quality-of-life improvement, with confidence that they do not increase thrombotic risk. Future studies should explore longer-term effects and mechanisms underlying these benefits.