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
London, Ontario, Canada – Unigen Inc., a natural product R&D and proprietary ingredient supplier, featured its 2nd clinical trial results for Maizinol® sleep supplementation at SLEEP 2025 (Seattle, WA) and Nutrition 2025 (Orlando, FL). The Maizinol® study was conducted by KGK Science Inc. (“KGK”), London, Canada, in a randomized, triple-blind, placebo-controlled, parallel design clinical trial (RCT). This rigorous clinical investigation represents a significant advancement in natural sleep support research, utilizing objective EEG measurements to evaluate Maizinol®’s efficacy and sleep-promoting benefits in adults experiencing sleep difficulties.
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. The Maizinol® EEG study enrolled 80 healthy participants with difficulties in falling asleep or staying asleep. The study yielded statistically-significant results over placebo 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.
At the SLEEP 2025, Unigen showcased compelling clinical data supporting Maizinol’s sleep-enhancing properties. Chief Scientific Officer Qi Jia, PhD, and Director of Pre-Clinical Research Mesfin Yimam, DVM, MS, presented the EEG clinical trial results in their poster entitled “A Randomized, Triple-Blind, Placebo-Controlled Trial Investigating A Standardized Corn Leaf Extract On Sleep In Healthy Adults With Sleep Difficulties.” The Maizinol® EEG clinical trial abstract was among the 1600+ selected for poster presentation at the conference.
SLEEP 2025 marked the 39th annual meeting of the Associated Professional Sleep Societies (APSS), is a joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). The SLEEP meeting provides evidence-based education to advance the science and clinical practice of sleep medicine, disseminates cutting-edge sleep and circadian research, promotes the translation of basic science into clinical practice, and fosters the future of the field by providing career development opportunities at all levels.
At NUTRITION 2025, A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial Investigating A Corn Leaf Extract (UP165) On Sleep Quality in Healthy Adults With Sleep Difficulties was presented as an oral presentation at the session of Nutrition 2025: “Bioactives for Brian and Cardiometabolic Health”.
NUTRITION 2025 is the annual flagship meeting of the American Society for Nutrition and focuses on the latest nutrition research and news. Held May 31-June 3 in Orlando, FL, the program featured scientific symposia and educational sessions, unpublished research studies presented in oral and poster sessions and flash talks, as well as award lectures delivered by distinguished leaders.
KGK is submitting this gold-standard RCT for peer-reviewed publication. With over 28 years of experience, KGK Science Inc. is a leading full-service 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. The Maizinol® study reflects KGK’s continued commitment to advancing evidence-based natural health solutions through rigorous science and innovative clinical research methodologies.
For further information about Maizinol® and the KGK clinical study, please contact:
Anusri Nair
Marketing Manager, KGK Science Inc.
Email: anair@kgkscience.com
Website: www.kgkscience.com
Kathy Markham
Marketing Manager, Unigen, Inc.
Email: kmarkham@unigen.net
Website: www.unigen.net
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 in vivo testing 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 Science Inc. is a premier North American contract research organization based in London, Ontario, specializing in high-quality clinical trials with a focus on nutraceuticals and emerging health products. Since its founding in 1997, KGK has successfully supported hundreds of companies through custom-designed clinical trials and strategic claim substantiation to help bring innovative products to global markets.
In addition to clinical research, KGK offers a comprehensive suite of services, including expert regulatory support, compliance solutions, participant recruitment, research support, and consulting services. To date, the company has conducted over 400 clinical trials across more than 40 health indications, published more than 150 scientific papers, enrolled over 40,000 participants, and collected more than 10 million data points.
Notice Regarding Forward-Looking Information:
This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company. The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.
