January 15, 2024 – Akay Bioactives unveils recent human clinical trial results featured in Frontiers in Nutrition (doi: 10.3389/fnut.2023.1200118), highlighting the impressive advantages of ThymoDream™—the patented black cumin seed oil—in addressing non-restorative sleep challenges within seven days. These findings suggest its potential as a supportive intervention for occasional sleeplessness.

The recent randomized double-blinded placebo-controlled investigation, utilizing 70 healthy volunteers who self-reported to have non-refreshing sleep issues, employed a multifaceted approach, incorporating actigraphy and a validated sleep questionnaire (RSQ-W) to systematically assess the impact of ThymoDream™ on various sleep parameters relative to placebo. Actigraphy, employed as an objective measurement tool, furnishes continuous data on sleep patterns throughout an extended observation period. Participants, equipped with devices capturing movement and activity levels, offered an unobtrusive means of obtaining precise insights into both the duration and quality of their actual sleep. Complementing this, participants contributed self-reported data through the application of the Restorative Sleep Questionnaire (RSQ-W), a rigorously validated instrument renowned for its effectiveness in gauging the rejuvenating aspects of sleep quality. This combined methodology ensures a comprehensive and scientifically rigorous evaluation of ThymoDream™'s effects on sleep metrics.

Results of the trial indicated significant improvements in sleep efficiency, total sleep time, sleep onset latency, and wake-after-sleep-onset. Within a mere seven days, individuals administered ThymoDream™, via 200 mg soft gelatin capsules once nightly, exhibited a remarkable 75.3% improvement in sleep quality relative to baseline (P < 0.001), surpassing a substantial 68.9% improvement when compared to the placebo group (P < 0.001). These findings substantiate ThymoDream™'s efficacy in ameliorating non-restorative sleep challenges within a short timeframe, without side effects, presenting it as a promising adjunct for individuals necessitating supportive interventions for occasional sleeplessness.

The results of this study along with previous studies on its effect on Stress, Sleep and Immunity enable brands to make substantiated structure-function claims that ThymoDream™ can help with stress and sleep without affecting memory. The formulation is well-suited for liquid-filled capsules, and softgels. “This is an example of our unique knowledge of holistic ‘Ayurvedic approach to Nutrition’ to provide unique health solutions. While black cumin is known for supporting immunity and inflammation management, our discovery and clinical work could explore a highly bioavailable patented composition in a completely new area of restorative sleep and stress management,” noted Frederik Krabbe Errebo, head of business unit Akay Bioactives. “This shows the power of what our integrated R&D model can do.”

ThymoDream™ is a patented and bioavailable black cumin seed extract made from Nigella sativa, standardized to deliver potent bioactives at a definite ratio. Produced with proprietary cold-press technology designed to preserve high levels of bioactives without the use of heat or solvents. With four compelling clinical studies behind it, ThymoDream™ manages occasional sleeplessness, stress, and immune health. ThymoDream™'s safety, efficacy, and unique mechanism of action have been substantiated to balance natural melatonin and cortisol levels in the body.

According to the Centers for Disease Control and Prevention, one-third of U.S. adults typically receive less than the recommended amount of sleep. Insufficient sleep is associated with numerous chronic diseases and conditions that pose a threat to the nation's health. Additionally, the sleep aid market, as projected by Allied Market Research, is anticipated to reach $54.7 billion by 2032, with a compounded annual growth rate (CAGR) of 6.3% expected from 2023 to 2033. This underscores the substantial demand for sleep aids and reflects the widespread challenges individuals face in achieving adequate and restful sleep.

About Akay Bioactives

Akay Bioactives (www.akaybioactives.com) is a global pioneer in natural and clinically substantiated bioactive ingredients. Driven by the purpose of amplifying nature’s ability to enhance human health, they sustainably transform natural resources into bioactives with substantiated health outcomes.

Their unparalleled clinical research and cutting-edge delivery technologies unlock the full potential of nature’s hidden abilities. With a vertically integrated approach and an agile partnership model, they empower their partners to accelerate and enhance innovation to support in-demand claims, improve health outcomes, and drive new consumer trends.

Akay Bioactives is a brand of the Oterra Group.