Unigen Announces Successful Results of Maizinol® in Second Clinical Study
UNIGEN ANNOUNCES SUCCESSFUL RESULTS OF MAIZINOL®, A NUTRACEUTICAL INGREDIENT, IN AN OBJECTIVE ASSESSMENT OF SLEEP PARAMETERS MEASURED BY ACTIGRAPHY AND EEG DEVICE
A randomized, triple-blind, placebo controlled, parallel clinical trial to investigate the safety and efficacy of Maizinol® on sleep quality in a healthy population with difficulty falling asleep or staying asleep.
TACOMA, WASHINGTON – October 8, 2024: Unigen Inc., a natural product R&D and proprietary ingredient supplier announces today its clinical trial results for Maizinol® supplementation on important parameters of sleep. The study was conducted by KGK Science Inc. (“KGK”), London, Canada, in a randomized, triple-blind, placebo-controlled, parallel design clinical trial (RCT). The study enrolled healthy participants with difficulties in falling asleep or staying asleep. The study yielded statistically-significant results on sleep quality including reduction in sleep latency, reduction in the number of nighttime awakenings, reduction in awake duration after sleep onset, improvements in sleep efficiency, increases in REM and NREM sleep, increases in total sleep time, and optimization of sleep structure without inducing a change in circadian rhythm.
KGK is submitting this gold standard RCT for peer-reviewed publication. KGK is a leading full-service premium contract research organization (CRO) and regulatory consulting firm, specializing in custom-designed clinical trials and expert regulatory support for the nutraceutical, cannabis, hemp, and psychedelic industries.
Maizinol® is an extract derived from the leaves of Zea mays L. (commonly known as corn) and contains a naturally occurring compound structurally similar to melatonin, with an affinity for melatonin receptors and stimulating melatonin synthesis. In a double blind, placebo-controlled sleep study published in Journal of Medicinal Food in 2023, Maizinol® was found to increase total sleep time and deep sleep time as measured by a fitness activity tracker, to improve sleep quality and efficiency as measured by Pittsburgh sleep quality index (PSQI) with no serious adverse events or clinically relevant changes in vital signs.
In this second clinical study of Maizinol®, a total of 80 healthy adult participants, ages 18-65 years, with difficulty in falling asleep or staying asleep, were randomized to either 500 mg daily Maizinol® or placebo (40 adults per group; 28-day study). Objective sleep measures (sleep times in different sleep stages, sleep efficiency, sleep latency, number of awakenings, number of awakenings >3 minutes) were assessed by an actigraphy and EEG (Electroencephalogram) device at baseline, day 14, and day 28.
The results showed that supplementation with Maizinol® 60 minutes before bedtime for 28 days significantly improved objective measures of REM sleep, NREM sleep, and total sleep time compared to placebo in a population with self-reported difficulties falling and/or staying asleep. These findings were supported by improvements in sleep latency and awake duration, which are particularly relevant for the studied population. These objective sleep measures were further supported by group improvements in subjective measures of sleep.
Maizinol® supplementation was found to be safe and well tolerated which is an important finding given the safety concerns over prescription sleep aids. Taken together, findings from the current study suggest Maizinol® may play a role in improving objective and subjective measures of sleep which is relevant for the maintenance of physical and mental health.
“Conducting gold-standard clinical studies with objective tools like EEG to investigate sleep quality is critical to further our understanding of the complex interactions between natural health products and improvements in sleep” says Dr. Erin D. Lewis, Scientific Director at KGK Science.
Unigen Chief Scientific Officer, Dr. Qi Jia, added “This study is a critical step toward providing consumers with a scientifically-based and safe sleep support ingredient – Maizinol® – that not only provides strong scientific substantiation of sleep benefits from Maizinol®, but also establishes a high standard to the nutritional industry to assess the overcrowded and self-claimed sleep support actives with objective measurement of sleep quality by actigraphy and EEG device.”
For further information about Maizinol® and the KGK clinical study, please contact:
Kathy Markham
Marketing Manager
Email: kmarkham@unigen.net
Website: unigen.net
Anusri Nair
Marketing Manager
KGK Science Inc.
Email: anair@kgkscience.com
Website: kgkscience.com
About Unigen, Inc.
Unigen discovers, develops, and manufactures proprietary natural-product active ingredients for dietary supplements, cosmetic and personal care products, prescription medical food and botanical drug products. The Company discovers its ingredients through its high-throughput screening PhytoLogix® approach applied to a proprietary well-annotated collection of botanicals and a legacy mining approach applied to botanicals having known medicinal benefits.
Mechanism of action, safety, and efficacy are documented with extensive preclinical in vitro and by human clinical studies. Unigen protects its discoveries with issued patents and patent filings in all major territories and manufactures its products to GMP standards. Unigen commercializes its proprietary ingredients through licensing and ingredient supply alliances with commercial partners engaged in the manufacture, distribution, and marketing of end-products in each of Unigen’s target markets.
About KGK Science
KGK is a leading North American contract research organization based in London, Ontario that primarily provides high-quality clinical research trials with a focus on nutraceutical and emerging health care products. Founded in 1997, the business has successfully helped hundreds of companies with custom designed clinical trials and claim substantiation strategies to move products into global markets. KGK’s other existing service lines include expert regulatory support and compliance solutions, participant recruitment, research support services and consulting services. Furthermore, the company has produced over 150 publications, executed over 400 clinical trials across more than 40 indications, amassed 40,000 participants in its database and collected 10 million data points. For additional information, please visit kgkscience.com.
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