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Cognitive Health Cognitive Health

The cognitive health market is seeing a surge in consumer demand for products that are portable, reliable and edible.

The unprecedented declines in mortality and fertility have resulted in a rapid population aging process in most developing countries, said the National Center for Biotechnology Information. Dementia has emerged as a public health problem as it is one of the most common diseases in the elderly and a major cause of disability and mortality.

According to the Alzheimer’s Association, an estimated 5.3 million Americans of all ages had Alzheimer’s in 2015. This number includes an estimated 5.1 million people age 65 and older, and approximately 200,000 individuals under age 65 who have younger-onset Alzheimer’s. And those numbers will continue to rise as the population continues to live longer.

The projected number of people with Alzheimer’s in 2050, has been approximated at 959,000, a 110 percent increase from 2010, according to the Alzheimer’s Association.

Upgrade Your Brain

As Baby Boomers reach retirement age the number of Americans experiencing decreased brain health and focus is on the rise. But declining cognitive function is not just age related. “Chronic stress associated with modern lifestyles can also result in difficulty focusing and remembering things. For example, just think how difficult it is to remember where the car keys are when pressed for time or feeling overwhelmed,” said Bruce Abedon, PhD, director of scientific affairs for Nutragenesis in Vermont.

“Recently we have seen a large number of startup companies driven by entrepreneurs with backgrounds outside of the dietary supplement industry,” added Chase Hagerman, brand director of Texas-based Chemi Nutra. “These enthusiastic business owners with backgrounds in the high-stress tech industry are drawn in by the nootropic category and the seeming appeal to ‘hack-their-brains’—a term reminiscent of technology. The idea is, you can swap your smartphone, tablet or laptop for an upgraded model; so why not try and improve your own central processing unit?”

Go Natural, Or Go Home

The increased awareness of the burden and cost of contracting neurodegenerative diseases, like Alzheimer’s, in addition to the potential adverse effects associated with pharmaceutical agents for treatment, has led to both older and younger consumers to demand natural and clinically researched ingredients to be used in cognitive health supplements, said Bryan See, regional product manager with New Jersey-based ExcelVite, Inc.

Ingredients addressing different aspects of memory health are being introduced to brain formulations, including brain signaling, anti-oxidative stress, membrane integrity, anti-toxicity, anti-brain aging, and more, explained Jennifer Gu, PhD, chief science officer with California-based AIDP.

The benefits of omega-3 fatty acid DHA and vitamin E tocopherols in supporting brain health are already widely known. However, a form of vitamin E called tocotrienols is gaining market attention with strong research evidence shown in supporting brain cell survival in the event of stroke, See shared.

“The tocotrienol ingredient used in the brain clinical studies is in the form of self-emulsifying delivery or bio-enhanced system, called EVNol SupraBio,” he said. “Unlike regular tocotrienol or vitamin E (oil extract), this self-emulsifying tocotrienol formula doesn’t rely on a high fat meal for absorption.”

According to Abedon, consumers are moving beyond traditional use of whole herbs, vitamins and minerals in the category of memory and cognitive health. They are purchasing, with increasing frequency, standardized extracts of botanicals that have been clinically tested to significantly enhance memory and cognitive benefits. “Branded, patented ingredients are particularly important due to their superior quality and excellent safety profiles,” he said.

“Besides proven clinical studies (being scientifically substantiated), the market is moving toward clean label and non-GMO (genetically modified organism),” See added.

Cognitive Food & Beverages

In addition to clean botanicals, consumers are turning to beverages for cognitive health, said Gu. This particular trend resulted in AIDP’s response in the form of Magtein, magnesium threonate, which has been studied for its effectiveness at reversing cognitive impairment, and returning cognitive function almost back to normal ability relative to age, the company said. The “gold standard” randomized, controlled, double-blind study was published in the Journal of Alzheimer’s Disease.

“The effect of magnesium threonate (Magtein) on cognitive ability was evaluated in four cognitive domains: executive function, working memory, attention and episodic memory by administration of the Trail Making, Digit Span, Flanker and Face-Name tests, respectively, as Baseline, Week 6, and Week 12,” the company stated. “These cognitive tests represent the best science available, based on the current consensus that multiple domains of cognitive should be evaluated to determine cognitive impairment. The cognitive domains selected were similar to those included in major cognitive studies. They are considered reliable for testing cognitive deficits and improvements.”

“Magtein is shown to effectively cross the blood-brain barrier and increase brain synaptic density by rejuvenating neural cells, attributing to its ability to improve memory and other cognitive functions,” Gu added.

Due to its clean taste, odorless, and high-solubility qualities it can be in both the nutraceutical and food/beverage markets, Gu continued.

Bluenesse by Maypro is also water-soluble. A fine, beige powder, it is a proprietary Melissa officinalis leaf extract, commonly known as lemon balm.

“Human clinical research shows that lemon balm supports a calm, positive mood and can reduce the effects of occasional stress,” said Dan Lifton, president, Proprietary Branded Ingredients Group, from New York-based Maypro. “Unlike other mood support ingredients, Bluenesse does not cause drowsiness, in fact research indicates that it improves indicators of alertness, focus, memory and learning.

With the food and beverage trend taking off, ExcelVite Inc. also launched their R&D teams to develop two forms of bio-enhanced tocotrienol ingredients to cater to the food and beverage market, as well as dietary supplement application.

EVNolMax, is a water dispersible natural, full-spectrum palm tocotrienol complex powder. EVNol SupraBio, is a patented and bio-enhanced natural full-spectrum palm tocotrienol complex liquid solution. Both of these products are bio-enhanced tocotrienol, which the bio-enhanced system ensures a consistent and increased absorption of tocotrienol (bioavailability), See explained.

The SupraBio system has been shown in human studies to improve oral bioavailability of individual tocotrienol isoform by up to 300 percent. In addition, a recent human tissue distribution study has conclusively proved that tocotrienol via oral supplementation of EVNol SupraBio is well-absorbed into the human plasma and is transported to vital human organs, including the brain.

A human clinical trial published in the American Heart Association’s journal, STROKE, reported that EVNol SupraBio supplementation for two years at 200 mg daily slows down the development of white matter lesions (WMLs) in the human brain.1 WMLs are closely related to vascular events of the brain and are indications of fragile brain vascular network.

“As consumers both young and old are reaching out for supplements to support cognitive health, they are also looking for simple, convenient, and on-the-go type of nutrient delivery formats to enhance cognitive health,” See said. “This has prompted the rise of brain health beverages and foods.”

“We collaborated with 3i Solutions from Wooster, OH, a leader in ingredient nanodispersion technology to come up with a solution to a formulation challenge for a couple phospholipid ingredients we produce [Mediator Phosphatidic Acid (PA) and SerinAid PhosphatidylSerine (PS)],” said Hagerman.

Both of the ingredients are fat soluble rather than water-soluble. “When customers would ask if they could use them in a beverage, we had to tell them they don’t mix well since oil and water don’t mix. 3i Solution’s nanotechnology allows us to have a raw material that can be added successfully to a beverage,” he continued.

More Than Memory

When consumers hear of cognitive health, many think of memory, and fear a future where cognitive impairment becomes a factor in their ability to live quality lives. However, long-term memory is not the only concern. There are some consumers who are looking for products that help with attention and stress in addition to memory benefits.

Cognitive health encompasses mood, stress and focus, as well as memory. In 2012 the American Psychological Association released a collective report, “Stress in America: Our Health at Risk,” that compared stress levels, and emotional tolls that stress has on individuals over a course of a few years. One such comparison compared the emotional and physical toll of stress to each other. “Americans report irritability or anger (42 percent); fatigue (37 percent); lack of interest, motivation or energy (35 percent); headaches (32 percent); and upset stomachs (24 percent) due to stress. A smaller percentage report having a change in appetite (17 percent) and sex drive (11 percent),” the report revealed.

NutraGenesis offers Sensoril, a “nutraceutical extract that works synergistically to not only enhance cognitive function, but also to help reduce stress and enhance mood based on the superior properties of the glycowithanolide bioactives it contains,” Abedon said.

Stress plays a major role in how our brain and body react to our environment. It is important to make sure that when we supplement for cognitive health, we keep in mind that our brain does more than remember the past, it affects our present and future state of being, as well.

Sensoril, not only helps with memory and mental clarity, consumers really feel the difference in mood, which helps them cope with life in general, Abedon said. It has been evaluated in multiple, randomized, double-blind, placebo-controlled human clinical trials that have demonstrated benefits in healthy subjects.

“In these trials, researchers utilized validated cognitive health tests that were both objective in nature and measured working memory, reaction time, and the ability to process and store information, as well as being subjective in nature.”

Other products for overall cognitive health from Maypro include: ETAS, a proprietary ingredient derived from the tough lower portion of asparagus stalks, which has been shown to increase quality of sleep, alleviate occasional stress, raise cognitive performance, reduce fatigue and improve stress response; and MicroPQQ, a specially formulated PQQ (pyrroloquinoline) preparation that combines a bio-adhesive polymer, natural wax, and J3-cyclodextrin to enhance dissolution and absorption in the human body, leading to higher levels of availability. Research suggests that PQQ protects nerve cells, improves cognitive function and alleviates occasional stress and sleeplessness. In addition, Maypro offers Venetron, a patented, purified extract of Apocynum venetum, which has some of the same active constituents of St. John’s wort. It has been shown in human clinical trials to promote a positive outlook, alleviate occasional stress and improve sleep quality.

Chemi Nutra makes two ingredients that aid in cognitive function that benefit more than just memory: SerinAid PhosphatidylSerine (PS) and AlphaSize Alpha-Glyceryl Phosphoryl Choline (A-GPC). AlphaSize A-GPC, derived from high phosphatidylcholine (PC) soy phospholipids, is a nutrient that occurs naturally in the human body, where it is involved in a multitude of very crucial biochemical functions, Hagerman explained. Phosphorylcholine, formed from A-GPC, migrates to the synaptic nerve endings found throughout the entire central nervous system, and in turn increases the synthesis and release of acetylcholine (AC). AC is a vastly important neurotransmitter present in both brain and muscle tissue. In the brain AC plays a key role in basically every cognitive function, while in muscle it is vitally involved in muscle contraction.

On the other hand, Hagerman said, SerinAid PS helps proteins that manage membrane functions that are involved in transmission of molecular messages from cell to cell, helps nutrients enter into cells, and helps harmful stress-related waste products to exit the cells.

“PS is so effective, the U.S. Food and Drug Administration (FDA) granted two health claims for it; indicating that it may reduce the risk of cognitive dysfunction and dementia in the elderly. This is especially notable since it is the only ingredient to have a qualified health claim for cognitive health,” Hagerman said.

Efficacy Matters

When selecting ingredients and formulating new products, Gu said there are six things to keep in mind: safety, efficacy/science, regulation, novelty, physical characteristics, and interaction with other ingredients. “When a product is supported by studies published in top journals, it shows strong science and quality and the significance it makes in the field,” Gu added.

See agreed. He noted that manufacturers should opt for ingredients with long histories of research across in-vitro, in-vivo, and human studies: in short, scientifically substantiated. They should also note ingredients with pharmacokinetic studies, like proven absorption and tissue distribution data in humans.

Of course, cGMP (current good manufacturing practice)-cerfitications, non-GMO, and other safety certifications, like kosher and halal, are also signs of quality ingredients. And if the demand from consumers is any hint, safe, natural and proven ingredients are being sought after by purchasers across all categories, and cognitive health is no exception.

Like the rest of the dietary supplement industry, one of the challenges associated with ingredients in this category is in the area of transparency, quality and ID testing, which is increasingly required for regulatory purposes and to satisfy consumer concerns about what is in their dietary supplement products, Abedon said.

“Sensoril is manufactured according to strict guidelines that maintain the highest level of quality and purity. Prior to sale, all raw materials are ID tested and the finished nutraceutical is evaluated for levels of bioactives, heavy metals, and microbial analysis via validated test methods,” Abedon explained.

“With watchful eyes dead set on the cognitive health category, it is more important now than ever to make sure your health product is in compliance with the rules and regulations of the nutrition industry. Thus, compliance influences research and development at the very basic level. Ingredients have to be approved for use in the health industry before you should even consider them for your formulation,” Hagerman said.

According to Hagerman, 2015 will go down in history for the health industry. It was a hallmark year, he said, with numerous high-profile case studies that made it into mainstream media’s negative limelight.

One such case was U.S. Senator Clair McCaskill’s (D-MO), three-pronged examination of dietary supplements that “specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease.” Her investigation was into the products themselves, the regulatory standing, and retailer vetting policies, Hagerman explained.

Branded ingredients that are backed up by published, clinical research, not just animal data or experimental research alone is key, Lifton said. “By using human research-supported ingredients in this way, consumers will be able to achieve optimal results and your product will be a big part of the reason why.” NIE

Resource:

1 Gopalan Y, Shuaib IL, Magosso E, Ansari MA, Abu Bakar MR, Wong JW, Karim Khan NA, Liong WC, Sundram J, Ng BH, Karuthan C, Yuen KH. “Clinical Investigation of the Protective Effects of Palm Vitamin E Tocotrienols on Brain White Matter.” Stroke 45, no. 5 (2014): 1422-8.

For More Information:
AIDP, (866) 262-6699
Chemi Nutra, (866) 907-0400
ExcelVite, Inc., +60 (05) 2014192
Maypro, (914) 251-0701
NutraGenesis, (802) 257-5345

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