Sleep supplement research on high as suppliers tease new sleep benefits from their nutrition ingredients: SupplySide West 2021 report

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The sleep market was a big focus at this October’s SupplySide West trade show, spurred by growing consumer demand. Ingredient suppliers Nutritional Outlook interviewed at the show revealed they are actively researching the sleep-health benefits of their ingredients—including teasing out the sleep-support potential of ingredients that had previously not been largely promoted for sleep health.

Maize-derived ingredient stretches from mood into sleep

Unigen Inc. (Tacoma, WA) is taking an existing branded ingredient called Maizinol, which it licensed and originally launched more than five years ago, primarily for mood support, and is now conducting studies on its potential sleep benefits. During the show, company president and CEO Qi Jia, PhD, discussed how Maizinol, an ingredient derived from immature corn leaves (Zea mays), might also assist with sleep.

Unigen has been exploring the sleep properties of Maizinol internally, including a clinical study showing the ingredient significantly increased deep-sleep time by 30 minutes when taken before bed. “We are pretty excited because Maizinol not only increased deep-sleep time but also had a significant reduction in cortisol levels in the early morning,” said Jia. Saliva testing showed a 30% reduction in cortisol levels compared to placebo, he said. “So, the benefit is quantifiable,” he added.

How does Maizinol aid sleep? Jia explained that it “works through the melatonin pathway. It increases the biosynthesis of melatonin. Also, the compounds are similar to melatonin, so it’s also binding to melatonin receptors.” Not only that, the ingredient doesn’t cause drowsiness.

In fact, he said, Maizinol might be a better alternative to melatonin, especially for those who experience adverse effects when supplementing with melatonin. Of Maizinol, Jia said, “I think this offers an alternative because it’s working in a similar way [as melatonin], but it naturally increases your own synthesis” of melatonin in the body. Some of the adverse effects experienced with melatonin supplementation might come from the fact that melatonin is a hormone, he added: “When you supplement a hormone, it interrupts your own biosynthesis process, and there are a lot of people who cannot tolerate, who can have…lots of dreams and dizziness in the morning.” Maizinol, he said, would sidestep these negative issues.

Unigen’s research on Maizinol is progressing on several fronts. The company is looking to get a manuscript of its aforementioned double-blind, placebo-controlled sleep study published in a peer-reviewed journal. In addition, Jia said, “We want to replicate this study, so we’re contacting some contract research organizations now. We want to run a 40-50 subject group and maybe also have subjects [use] electroencephalography (EEG) to monitor brain waves during sleep so that we can better define REM sleep and non-REM sleep.” The company is also looking into regulatory approval for Maizinol, including doing safety studies to support a Generally Recognized as Safe (GRAS) finding, and seeking regulatory approvals in other markets, including Europe and China. Jia pointed out that in the U.S., the ingredient would be considered an Old Dietary Ingredient (ODI) because it comes from corn shoots.

Jia said the science to support Maizinol is strong so far. “We have a dose-correlated study, we have an animal study, and we have mechanism of action, so it’s very solid in the science. So, we are very happy to have a chance to provide it to everybody.”

PEA’s sleep benefits: Good for athletes?

Gencor (Irvine, CA) has been feverishly studying the benefits of its palmitoylethanolamide (PEA) ingredient Levagen on many levels. Levagen, as well as its cold-water-dispersible version Levagen+, has been clinically shown to have anti-inflammatory and other benefits for joint health, immune health, exercise recovery, and mood, to name a few.

In October, Gencor announced the publication of a 103-subject, eight-week, randomized, double-blind, placebo-controlled study¹ showing that Levagen+ supported healthy sleep by reducing the time needed to fall asleep. Not only that, it also improved conditions upon waking, including helping subjects feel more fully awake faster and improving cognition upon waking. The researchers explained that the body’s endocannabinoid system plays a role in regulating many circadian processes. Because PEA, like the hemp phytocannabinoid cannabidiol (CBD), operates on the body’s endocannabinoid receptors, it might have an influence on sleep behavior.

PEA may also pose advantages for one specific population for whom sleep is essential: athletes. At the SupplySide West show, Maggie McNamara, Gencor’s marketing director, said the company has run a trial with Gloucester Rugby in the UK, whose athletes took Levagen in combination with Gencor’s Hydrocurc curcumin ingredient (Curcuma longa) for a six-month period and saw improvements in sleep, performance, and recovery. Now, McNamara said, the company is pursuing a U.S. trial with Levagen+ in triathletes.

She pointed out that athletes “felt like if they were getting better sleep, they would be healing quicker.” Gencor is also studying the fast-acting nature of Levagen because “when you’re sleep deprived, you don’t want something that’s going to work in two or three months; you want something that’s going to work relatively quickly,” McNamara said.

For Gencor, the sleep market might be one of the biggest opportunity markets for PEA moving forward. “For athletes who are dealing with inflammation, dealing with pain, trying to improve performance, and requiring help with sleep so that they in turn can perform better and heal quicker, Levagen is the absolute perfect ingredient for an athlete,” she said.

Furthermore, McNamara pointed out, unlike CBD, PEA is 100% legal as an ingredient in many countries. Where athletes are concerned, it is also free of any substances banned by the World Anti-Doping Agency.

Spearmint and green tea aid sleep, waking

At SupplySide West, Kemin (Des Moines, IA) showcased its recently launched DailyZz branded ingredient supported by a human clinical trial² published earlier this year showing that it significantly improved quality of sleep as well as performance the next day, including better concentration, reaction time, and visual recall and processing.

The 89-subject, 30-day, double-blind, randomized, placebo-controlled trial showed that 485 mg of DailyZz taken 30 minutes before bedtime promoted these positive effects as early as one week into supplementation, compared to placebo. Test methods included computerized performance testing and validated sleep diary surveys.

The ingredient is a blend of proprietary spearmint and green tea extract, explained Penny Woods, Kemin’s marketing director, at the SupplySide West show. “When you want to wake up and feel like you got a good night’s sleep, that’s really what this product does,” she said.

Reference

1. Rao A et al. “Palmitoylethanolamide for sleep disturbance. A double-blind, randomised, placebo-controlled interventional study.” Sleep Science and Practice, vol. 5 (2021)
2. Tubbs AS et al. “A randomized, double-blind, placebo-controlled trial of a polyphenol botanical blend on sleep and daytime functioning.” International Journal of Environmental Research and Public Health. Published online March 16, 2021.