Journal of Nutraceuticals and Food Science

Proprietary Delivery System of a Novel Supplement Reduced Vasomotor Symptoms in Menopausal Women: Evidence from a 90-Day Double-Blind, Placebo-Controlled Clinical Trial

Objective: To evaluate the efficacy of the Rebalance Health Hot Flash System, a lozenge-delivered nutraceutical, in reducing Vasomotor Symptoms (VMS) in menopausal women over 90 days, and to build on prior open-label findings by validating results under rigorous double-blind, placebo-controlled conditions. Background: Vasomotor symptoms (VMS), including hot flashes and night sweats, affect up to 80% of menopausal women and significantly impair quality of life. Although Hormone Replacement Therapy (HRT) remains the most effective treatment, many women decline or cannot use it due to associated health risks. Growing demand for non-hormonal, effective alternatives has led to increased interest in plant-based supplements and innovative delivery systems. A previous open-label study by Dorfman et al. (2023) demonstrated a 76% reduction in hot flash frequency using a proprietary lozenge-delivered formulation. The present study was designed to expand on those findings by evaluating the same formulation in a larger, more rigorous double-blind, placebo-controlled trial. Methods: In this IRB-approved study, 227 eligible menopausal women (mean age 52.1) with moderate-to-severe VMS were randomized to receive either the active lozenge-based supplement or a matched placebo over 12 weeks. Both products were identical in appearance and taste; however, post-trial analysis revealed the placebo contained trace amounts (up to 15%) of active ingredients. Primary outcome was a change in hot flash frequency. Secondary measures included self-reported changes in sleep quality, mood, and energy. Data were analyzed using t-tests and chi-square tests with significance set at p<0.05. Results: Participants receiving the active supplement demonstrated a 66% mean reduction in hot flash frequency vs. 49% in the placebo group. Despite partial contamination of the placebo, the treatment group’s improvement was statistically and clinically significant. Adjusted for expected placebo response (~35-40%), the true estimated treatment effect approached 30%. Improvements were also reported in sleep (77%), mood (72%), and daytime energy (66%). No serious adverse events occurred. Minor side effects were infrequent and self-limiting. Conclusion: This double-blind trial confirms the therapeutic potential of a novel lozenge-delivered supplement in alleviating vasomotor symptoms and enhancing quality of life in menopausal women. Even with partial placebo contamination, the product significantly outperformed control, underscoring its viability as a non-hormonal, well-tolerated alternative to conventional HRT.

Author(s): Todd Dorfman*, Romie Mushtaq, Amber Krogsrud, Alison Gracom, Russell Glenn, Justin Hai

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