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A Stress-free Dose of Z’s

Sleep Support Sleep Support
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Having life cause its share of stress can be difficult enough to deal with, especially when it affects sleep. Natural ingredients and products are teaming up to help consumers get the sleep they yearn for.

It’s safe to say, experiencing some sort of stress in life is inevitable. The reasons behind it can vary as people face different situations at school, the workplace or social relationships. In fact, according to 2014 stress statistics gathered by both the American Psychological Association and the American Institute of Stress, 73 percent of people in the U.S. regularly experience psychological symptoms caused by stress, while 77 percent of people regularly experience physical symptoms caused by stress. More so, it can take a toll on a person when sleep is compromised.

Aware of the situation, natural ingredient suppliers have developed and continue to develop ingredients for products that not only calm one’s stress, but can also help one get a good night’s sleep.

Ingredients & Concerns

When it comes to sleep and stress management, ashwagandha is a major contributor—ingredients such as Sensoril, a brand of ashwagandha root and leaf extract, have made it a bit simpler for formulators to use.

“Finished goods companies are recognizing that consumer demand is for products that give recognizable benefits and help them feel less stressed and sleep better,” noted Bruce Abedon, PhD, vice president of scientific and regulatory affairs at Vermont-based NutraGenesis LLC. “That is why these companies are choosing clinically tested ingredients like Sensoril standardized ashwagandha root and leaf extract, which was shown to significantly reduce stress and sleeplessness in a randomized, double-blind, placebo-controlled clinical trial. Sensoril’s experiential benefits in these areas have made it the top-selling patented root and leaf extract of ashwagandha in the industry. Sensoril also is a go-to ingredient for formulators because it is self-affirmed GRAS [generall recognized as safe], is easy to work with and water-soluble so can also be used in liquid delivery systems, is non-GMO [genetically modified organism] and gluten free, and comes in both conventional and certified organic versions.”

Another dual-action ingredient is Lactium, an Ingredia Nutritional product (based in France, that also developed CranMax, Benexia and Celadrin), which not only helps with sleep, but decreases “anxiety-related symptoms” as well, according to the manufacturer’s website.

“Lactium is a one-of-a-kind hydrolysate of milk proteins that contain a bioactive peptide with relaxing properties which regulate stress naturally,” said Mitch Skop, senior director of new product development at Pharmachem Laboratories Inc. in New Jersey. “In addition, Lactium is capable of facilitating and promoting sleep, with no or minimal sedative properties.”

As a result, Skop added that when producing these natural ingredients, manufacturers should make sure that they do not result in the “hang-over” type of side effects that is associated with traditional medication. Abedon agreed. “For sleep, the main concern is that the ingredient helps people fall asleep and stay asleep without having sedative properties. In this way, when people wake up they feel refreshed,” he said. “For stress, the main concern is that the ingredient is experiential, which is why Sensoril is such a successful ingredient in this area. Sensoril provides these kinds of healthy, sleep-related benefits.”

Finding Ways to Innovate

When appealing to customers, it is helpful for creativity to be involved in the process. Iowa-based Kemin Industries, Inc. for instance, via its Human Nutrition and Health division, has made its innovative mark by trendsetting.

“Kemin developed Neumentix from patent-pending, non-GMO, spearmint plant lines. These plants are grown on family farms in the U.S. in accordance with good agricultural and sustainable farming practices,” said Kim Colletti, global cognition product manager with the company. “In fact, Kemin’s spearmint plants are the first spearmint to be certified sustainably grown in the U.S.

“These special plants serve as the source for this innovative dietary ingredient,” Colletti explained. “The native polyphenolic profile of the leaves is harnessed through a patent-pending drying technology followed by a gentle water-extraction method that preserves and maintains the natural phenolic constituents, which are greater than 50 in number. The resulting extract is dried and undergoes rigorous quality testing prior to release. This exciting cognitive ingredient is targeted to not only support cognitive performance specifically, focus and working memory, but also support the ability to get to sleep quicker. Additionally, looking closer at how key molecules in Neumentix may work, there are four potential mechanisms of action—antioxidant defenses, protection of existing neurons and growth of new neurons, as well as through nerve transmission.”

In addition, Nutragenesis’ ashwagandha product provides innovation through practicality and efficacy. Not only are both the roots and leaves are utilized, but its beneficial content is believed to be greater. “Most ashwagandha ingredients are derived from roots only,” Abedon noted. “Sensoril is an innovative nutraceutical ingredient because its unique manufacturing process utilizes both roots and leaves of ashwagandha for the extraction process. Ashwagandha leaves are naturally richer in glycowithanolide bioactive content than roots. This results in Sensoril having the highest levels of ashwagandha glycowithanolide bioactives of any ashwagandha extract sold (Sensoril is standardized to a minimum of 10 percent glycowithanolides). The premium bioactive content allows Sensoril to be highly effective at a low daily dose.”

Ease of use is also a consideration for stress and sleep products. Customers often prefer finished products that can be consumed quickly and with more convenience, and Skop pointed out that Lactium succeeds on both levels.

“Lactium,” he said, “can be offered in a number of ways, including ready-to-drink beverages, powdered ready-to-mix drinks, soft chews, gummies and in a tasty hard candy form. This is especially ‘sweet’ at night, as it could be considered a little treat while winding down before bedtime.”

Market Status

Experts in the natural ingredient industry concur—as long as people continue with their ways of life, stress will be an ongoing part of the day. Consequently, this can result in a lack of sleep for some.

Falling short in the sleep department does not go unnoticed, as a large portion of the population is aware that sleep is a prime component of living a balanced, healthy life.

Brian Zapp, director of marketing with Applied Food Sciences, Inc. in Texas found this to be anything but a shock.

“It is no surprise that people value their sleep,” he observed. “Eighty-eight percent of the U.S. general population said getting adequate sleep is extremely important in how they maintain a healthy lifestyle (NMI, April 2017). This was the largest segment of concern, ahead of mental attitude and stress management.

“But some interesting data suggests that consumers also feel they are falling short in their health goals in achieving that sleep,” Zapp added. He pointed out that 42 percent of the U.S. population indicated that, over the last 10 years, their ability to get a good night’s sleep has gotten worse (NMI, April 2017). What’s also telling is that 55 percent of those polled also feel that their energy level has worsened over the last 10 years as well (NMI, April 2017). Americans tend to be overworked and under-rested. “To supplement our lack of energy,” Zapp said, “many Americans fill their days with caffeine, so it is no wonder, then, that the U.S. population is left hardwired and their quality of sleep is suffering.”

Zapp added that:

• Around 70 million Americans have sleep problems (The National Center on Sleep Disorders Research)
• Relaxation beverages are a $218 million industry worldwide (IBISWorld, 2016)
• More natural solutions are needed to compete with the largely dominant OTC (over-the-counter) and pharmaceutical sleep solutions.

With various issues surrounding people’s difficulty sleeping, a common response would be to seek a solution to the problem. With prescription medications presenting unwanted consequences, some individuals are seeking alternatives.

“Consumers are becoming more interested in natural sleep remedies due to concerns with side effects, dependency, and safety of prescription medications,”1 noted Colletti. “Neumentix Phenolic Complex K110-42, an extract produced from Kemin’s patented spearmint varieties, meets the need for a safe and natural sleep aid. Neumentix is not only for working memory improvements, but also is shown to support sleep. People who took Neumentix for benefits in working memory, found they fell to sleep faster and easier at night. When taken in the morning, participants taking 900 mg of Neumentix reported that they got to sleep easier and faster at night compared to subjects who took placebo.”2

Formulation & Research

When it comes to providing ingredients, suppliers must be able to cover all bases to ensure top-notch quality.

“An ingredient should be clinically efficacious, regulatorily compliant, competitively priced, well tolerated, possess a low efficacious dose, be easy to work with, have methods that exist to test it analytically for bioactive content and ID it qualitatively to meet GMP [good manufacturing practice] requirements and have no supply issues,” said Abedon. “Sensoril ashwagandha extract meets these requirements.”

After being asked about tips for successful formulation, Zapp referenced Kava-kava (piper methysticum), a plant grown in many of the South Pacific islands. He noted, “the active compounds in kava, called kavalactones, have been studied in more than a dozen different human clinical papers over the last 20 years for their benefits in anti-anxiety, stress and sleep support (Pittler, 2000).”

Although these specific ones apply to the mentioned botanical, Zapp suggested questions that ingredient manufacturers keep in mind when formulating. These can be altered to a specific ingredient.

1. Are your suppliers using only noble cultivars that have grown to maturity (about three years)?

2. Due to microbial issues, are your suppliers overseeing harvesting utilizing standardized practices that eliminate environmental contaminants?

3. Are your suppliers manufacturing only the correct parts of the plant, namely the root and rhizome? The actives in kava are present throughout the plant, so avoid micronized ingredients that are not clearly identified.

4. Kava can have several extraction methods. By optimizing the beneficial lactones and reducing or eliminating the negative ones, are your suppliers providing you with the safest extract, that formulation experts can confidently use in products?

5. How are your suppliers scientifically validating the measurement of those actives?

Skop stressed the validation of ingredient claims. For example, Lactium promotes sleep while producing “no or minimal sedative properties.” In fact, a study supporting this was published in the peer-reviewed scientific journal, Behavioural Brain Research. Pharmachem is concerned with proving the effectiveness of this hydrolysate, Skop noted.

“The study authors found that Lactium induces sleep promotion as shown by an augmented pentobarbital-induced sleep in mice and an increased slow (delta) EEG wave in rats. This sleep-promoting effect is probably mediated through the GABAergic neurotransmitter system,” Skop explained. “The probable sedative effect of Lactium was evaluated through the open-field and rota-rod test, and compared with the results of mice treated with the benzodiazepine drug, diazepam. Consistent with previous studies, diazepam decreased (after single treatment) the locomotor activity of mice in the open-field test. A decreased locomotor activity in this test is considered to reflect the sedative effects of a substance. Lactium did not significantly alter the locomotor activity of mice. This result indicates that this substance has no strong sedative effects. Similar results were observed in the rota-rod test.

“In the study, Lactium was orally administered in 75, 150, 300 or 500 mg/kg of body weight. Then, acute or repeated behavioral changes consequential to Lactium consumption were observed in various experimental procedures that would characterize the sedative (open-field and rota-rod test) and sleep-promoting (pentobarbital-induced sleeping test and EEG monitoring) activities of a substance. The most commonly used and prescribed benzodiazepine, diazepam, was used as a reference drug in these experiments.”

Being that proof of validity is a necessity, the current stress and sleep market has shown that values within the industry are continuing to increase.

“The current market requires higher standards for stress and sleep ingredients compared to a decade ago,” observed Abedon. “In greatest demand are ingredients that are supported by one or more double-blind, placebo-controlled, human clinical trials which demonstrate an ingredient’s superior efficacy in healthy subjects.” NIE

References:

1 Passport. Is the perfect sleep a dream? – Trends in calming and sleeping products, June 2014. Euromonitor.

2 RDBPC 12-week study (Fonseca et al., [Abstract] American Academy of Neurology Conference, Washington D.C., 2015.) evaluated healthy men and women between the ages of 50 and 70 with age-associated memory impairment. The study showed significant differences between active and placebo groups on improvements in working memory and ease of falling asleep. Working memory is a type of short-term memory system that allows temporary storage and manipulation of sound, speech, visual and spatial information. Working memory is critical to a wide range of cognitive tasks including attention, multi-tasking and complex thought, is highly correlated with measures of mental aptitude and has been found to be affected by the aging process and other factors such as stress or lack of sleep. Please contact Kemin for details on clinical findings.

For More Information:
Applied Food Sciences, Inc., (800) 345-9666
Kemin Industries, Inc., (515) 559-5100
NutraGenesis LLC, (802) 257-5345
Pharmachem Laboratories Inc., (800) 526-0609

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