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Nootropics for healthy cognitive function

People in many countries, including the U.S., are experiencing an increased life span.1 However, the aging population aims not just for increased, but optimized, years of life. Paramount to this are strategies to improve cognition or delay age-related cognitive decline. Supporting cognitive function is something that can, and should, be considered, even before the earliest signs of dementia are noticed.

Nootropic, a term coined in 1972 by Corneliu E. Giurgea, Ph.D, refers to a nontoxic substance that enhances learning and memory, facilitates communication between the brain hemispheres and enhances neurological resilience.2 Nootropics are commonly utilized to prevent or support early states of cognitive decline; they are also utilized by those who simply wish to optimize their cognitive function.

Cognitive function can be enhanced in a variety of ways. Studies show high levels of free radicals in the brains of those with cognitive decline.3 Antioxidants that can cross the blood-brain barrier tend to support cognitive function and protect the brain from the expected effects of aging. Vasodilators increase blood perfusion to the brain, enhancing oxygen levels and aiding glucose utilization.4 Substances that support neurotransmitter levels, particularly acetylcholine (ACh), can treat dementia.5 Finally, substances that support neurogenesis and increased neurological plasticity via modulation of brain-derived neurotrophic factor (BDNF) show great promise in enhancing cognitive function.6

Ginkgo bilboa (ginkgo) leaf is a well-known nootropic herb. Ginkgo trees belong to the Ginkgoaceae family, an ancient family cultivated for thousands of years for medicinal use in China. Much of the ginkgo used in research studies is a standardized product (EGb 761) of 22 to 27% flavonol glycosides, 5-7% terpene lactones, and less than 5 ppm ginkgolic acids. Ginkgo increases circulation to the brain, supporting glucose levels and adenosine triphosphate (ATP) utilization, and decreasing free-radical damage. Nootropic effects may also be due to increased levels of BDNF.6 Ginkgo is most effective when used for at least six weeks; long-term dosing is safe if the patient doesn’t have a clotting disorder or using anticoagulants (ginkgo thins the blood and should also be discontinued prior to surgery). Adulteration/contamination of ginkgo can be a concern,7 so analysis should be done on ginkgo sources to ensure a high-quality product.

Bacopa monnieri (water hyssop) is an Ayurvedic herb traditionally used as a medhya rasayana (memory/intellectual enhancer). Water hyssop grows in swampy or marshy areas; the arial portion of the plant is used, making it a very sustainable product. Sometimes referred to as brahmi, water hyssop is often contaminated with Centella asiatica.8 Water hyssop is a potent antioxidant that can cross the blood-brain barrier. Administration is protective against toxic exposure, including tobacco and common environmental contaminants with neurotoxic side effects.9,10 Water hyssop also increases cerebral blood flow and supports ACh levels.9 Additionally, early research seems to indicate enhancement of BDNF.6 Multiple studies have shown water hyssop improves memory acquisition and retention, as well as attention and memory processing. Results are most pronounced after three months of administration; short-term memory improvements are not seen in research studies, although many patients feel subjectively better even with short-term administration.

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Product formulation with plant-based proteins

The increasing popularity of, and consumer demand for, plant-based foods has created a whole new set of challenges for product developers. Whether creating plant-based foods that eat like their animal protein counterparts or developing great tasting standalone plant-based products, the obstacles can be significant.

Formulating with plant proteins requires a juggling act when it comes to balancing the functionality, sensory impact, nutrition profile, regulatory status and cost impact of the various ingredients. Two main challenges unique to plant proteins include perfecting functional and sensory attributes.

Functional

Animal and plant proteins are very different in their structure and functionality. While animal proteins are fibrillar and fibrous and play primarily a structural role, plant proteins are less organized and are globular and play more of a functional role. This results in differences in analytical measures such as oil- and water-holding capacity, emulsion capacity/stability, and foaming capacity/stability along with corresponding functional differences in gelation, emulsification, water/fat retention, matrix formation, viscosity, etc.

Protein content and quality also differ significantly between animal and plant proteins. Animal-sourced proteins are complete—containing an adequate proportion of each of the nine essential amino acids. Plant-sourced proteins—with the exception of soy—typically are not complete proteins and must therefore be strategically blended with other complimentary proteins to achieve the desired amino acid composition.

Sensory

In addition to structural differences, plant proteins each have their own unique flavor volatiles that often require masking or manipulation. These volatiles can include earthy, grassy, beany, “green,” hay, cardboard and “dirty,” just to name a few. Texturally, plant proteins can differ significantly, with some being dry and chalky, and others being described as gritty or sandy.

In terms of adding flavors to plant proteins, one faces not only the challenges of masking the undesirable flavors mentioned above, but also is challenged with the flavor “dampening” (binding) effect that plant proteins have. Plant proteins will require bolder and more impactful flavors (and possibly a higher usage rate for seasonings and flavors) to compensate for this dampening effect.

While the increasing popularity of food products made with plant proteins does present some new and unique challenges to the product developer, there are flavors, functional raw materials and processing methods that are available to successfully work through these challenges. Given the rapidly increasing consumer demand for new plant-based food products, flavor and functional ingredient suppliers are responding, and are constantly developing new solutions for food and beverage manufacturers.

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Trade groups to Congress: Authorize CBD in supplements

Four dietary supplement trade groups on Tuesday urged Congress to pass legislation clarifying hemp-derived CBD is a lawful dietary ingredient if the supplement meets established product safety and quality criteria.

Lawmakers also were asked to devote sufficient resources to shield consumers from unsafe CBD products.

While FDA has been examining the potential for a rulemaking that would authorize CBD to be added to food and marketed as a dietary supplement, agency officials have stressed such a process could take several years to complete.

Industry representatives have expressed fears that a lack of federal oversight could endanger the health of the public and continue to foster an environment of uncertainty, stymieing investments and innovation.

The U.S. market is already inundated with CBD products and a patchwork of state testing and labeling laws governing them.

Since at least 2015, FDA has asserted CBD can’t be marketed in a dietary supplement under federal law because, in short, the compound was first studied as a pharmaceutical drug. Last year, the agency approved the first CBD medicine, Epidiolex, to treat seizures associated with two severe forms of epilepsy.

Despite the drug-related exclusion above, the Federal Food, Drug & Cosmetic Act (FD&C Act) grants the head of the U.S. Department of Health and Human Services (HHS) discretion to authorize CBD to be marketed in supplements.

In the Oct. 8 letter to Congress, the trade associations noted any CBD products subject to such a “limited waiver” would need to meet the definition of hemp in the 2018 Farm Bill and comply with applicable requirements of the FD&C Act and FDA’s regulations related to dietary supplements, including requirements for new dietary ingredients.

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Applying the ‘E’ for joint health

Whether it’s an aging Boomer, an overworked Gen X weekend warrior or an active Millennial, maintenance joint health is increasingly a top daily concern. It’s a concern that spans generations and is driving consumers to seek out great information on natural solutions. Which raises the specter of the “E” in DSHEA.

That “E” stands for education. The concept behind the Dietary Supplement Health and Education Act of 1994 (DSHEA) was not only that dietary supplements were safe, but they are beneficial. That “E” stands for the opportunity to educate the consumer, and the law allows education to be available. Consider the critical discussion regarding claims for dietary supplements. That special allowance is present so that meaningful—as well as truthful and not misleading—educational information could be delivered to consumers.

Of course, there is a challenge with that when it comes to the topic of joint health. Even looking at this challenge from two widely different angles, the challenge is simple: Claims about joint health are tough to make. Add to this the desire to discuss the substantiated potential of some nutrients to affect minor pain and inflammation, but also the cost of such substantiation, and what we see in the market is more borrowed science that still doesn’t comply with the law.

FDA several years ago determined that inflammation claims were generally equivalent to disease claims, with few exceptions. When considering the limited potential for presenting acceptable pain relief claims and the preclusion of discussion of joint health, we have a claims quagmire. Substantiation alone for joint health support is challenging since most clinical endpoints would be either too long to measure realistically (populations with dietary components and statistically significant effect on joint health) and/or require evaluation of who would be considered “diseased” individuals. That substantiation, in FDA’s current thinking, is not appropriate.

However, I believe we can educate the consumer in those areas with the relative regulatory impunity; the emphasis in the approach lies in the “E” portion of the acronym and other allowances within the law.

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State hemp and CBD is still not easy to navigate

As FDA continues to contemplate potential regulatory pathways for hemp-derived CBD, an increasing number of states are moving forward with their own laws and policies aimed at regulating this popular product category, especially in the dietary supplement and food space.

Several states are imposing robust testing, labeling and registration requirements for these products—with more likely to follow—or restricting the sale of hemp and CBD-containing food and dietary supplements altogether, citing concerns about the absence of federal oversight.

Unfortunately for companies operating in this space, not all these state mandates are similar. Coupled with THC testing issues, many companies are faced with logistical challenges and supply chain headaches when it comes to navigating the various state regulations (and risks) for CBD and hemp products.

In addition to legalizing hemp and its derivatives, such as CBD, the legislation also directs USDA to create a regulatory framework for approving state-developed hemp plans as well as a federal plan for states that choose not to have primary oversight for the regulation of hemp.

Many states are currently in the process of developing hemp plans, which are primarily focused on the cultivation of hemp and related issues such as licensing hemp growers and THC testing. At the same time, they are also taking the opportunity to place restrictions or limits on the manufacture and distribution of finished products.

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Standardization of the ‘blessing seed’

Over the past several decades the healing benefits of black seed (Nigella sativa) have become a significant focus in the world of medicine; more specifically, the oil of these seeds has become the primary focus. To sort through the murky environment of black seed oil (BSO), we need to take a closer look at the current research into what makes this BSO effective and what to look for when purchasing a BSO ingredient.

For analogy purposes, the game show “To Tell the Truth” comes to mind. A person of some notoriety and two impostors try to fool celebrity panelists into choosing one of the impostors instead of the real person. Each celebrity has some time to question the three contestants; while the fakes can lie, the real person has “to tell the truth” about themselves. After every celebrity has had time to question them, they guess who the real person is, and each wrong guess earns the trio cash to split among themselves.

The reference of “To Tell the Truth” is used due to the number of BSO ingredients available in the marketplace that do not have the clinical research “to tell the truth” leaving many people guessing what a valid source of BSO is.

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Sustainability challenges in the supply chain

Sustainability from a natural products corporation comes from many operations; however, the department that will be tasked in implement the policy, whatever that form may be, will be supply chain. Therefore, the supply chain professional running the program will have to wear many hats in order to accomplish this task.

From a supply chain standpoint, the initial reaction to implementing a sustainability program would be the impact on cost. Other impacts could be potential changes to the supply bases, quality, availability and continuity of supply. In addition, the company will need a coherent sustainability mission statement to implement the program.

Supply chain professionals have multiple touch points in any organization; they need to be able to engage and influence other departments in an effective manner. It is critical to understand the company mission statement regarding sustainability, and there is alignment across the organization from marketing, finance, production and logistics. In some cases, supply chain may have to help sell the idea.

Sustainability and corporate social responsibility

Sustainability must first be adequately defined before a program can be implemented. The United Nations’ World Commission on Environment and Development in 2008 defined sustainability as “development that meets the needs of the present without compromising the ability of future generations to meet their own needs”.

From here, we can tether sustainability to corporate social responsibility (CSR). CSR is not as universally adopted. It could a different concept for each organization despite the increasing pressure for the need to do so.

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Considerations for success in the women’s health market

As with any other population, women have unique nutritional needs, life challenges and preferences that influence their purchasing decisions. Clinical studies have indicated a plethora of promising women’s health ingredients to help address nutrient shortfalls and enhance well-being at all life stages. In fact, Cornell University research identified a correlation between increased choline intake in pregnant women and higher information processing speeds in their infants (FASEB J. 2018;32:2172-2180). Additional studies are examining the potential brain health benefits of maternal choline intake as the children reach older ages, from 7 to 15. The importance of maternal health and proper fetal nutrition is well established, but research supporting the long-term effects gleaned secondhand, so to speak, is a game-changer.

A few key considerations can assist product developers looking to reach female consumers.

Identify the target audience

Although a given when creating any product, the women’s health category isn’t always clear-cut. Women from their teens to their 40s may be taking prenatal supplements. Market trends indicate some consumers are looking for proactive nutritional support decades earlier than women of the past, so Millennials may be seeking joint health products with different motivation than their parents, and likewise, their grandparents. The same goes for beauty-from-within products and more.

Create the right formulation

Dozens of ingredients are popular in women’s health products, including omega-3 fatty acids, vitamins, minerals, protein/collagen, botanicals, carotenoids, probiotics, enzymes, yeasts, collagen and other nutrients. Drawing from the Ayurvedic practice of addressing various aspects of well-being, combination formulas are increasingly popular. Some women may follow a plant-based diet, and therefore require a vegetarian or vegan product. For others, organic positioning is a selling point.

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Recent research on brain-boosting nutrients

Everyone wants the best brain they can have. The U.S. Centers for Disease Control and Prevention (CDC) defined a healthy brain as “one that can perform all the mental processes that are collectively known as cognition, including the ability to learn new things, intuition, judgment, language and remembering.” Several dietary ingredients have recently shown promise for safely improving human cognition.

In these studies, “significantly improved” indicates superior benefit, with a probability (“P value”) of at least 95 percent that the finding is real. Animal studies are not covered because they do not consistently predict human benefit.

The brain makes and consumes huge amounts of energy, for which it needs supplies of nutrients out of proportion to its small size (Frontiers Mol Neurosci 2018 Jun 22;11:216. DOI: 10.3389/fnmol.2018.00216.) But the current food supply falls far short of being sufficient for brain (or body) health. Based on ongoing findings from large CDC surveys, the 2015-2020 Dietary Guidelines for Americans listed magnesium; vitamins C, D and E; and choline among “underconsumed nutrients.” All are vital to cognitive performance.

This gives consumers a good reason to take a good multivitamin. Analyses of the national U.S. population survey data established taking a daily multi vitamin-mineral helps offset the nutrient gap in the U.S. food supply (Nutrients. 2017 Dec 22;10(1). pii: E4. DOI: 10.3390/nu10010004 and Nutrients. 2017 Aug 9;9(8). pii: E849. DOI: 10.3390/nu9080849).

Taking a multivitamin formulated with the most proven ingredients provides a steady supply of the nutrient “nuts and bolts” needed by the enzymes that make cognition possible.

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Protein powders for an expanding consumer base

Protein powder use among natural consumers is on the rise, according to SPINS data. While the US$892.5 million protein powders segment grew 4.2% over the past year (the 52 weeks ending April 21, 2019), sales in the natural channel of retail grocers grew 8.8% to $156.1 million, outpacing growth for the greater cross-channel segment. Tracking the sales of naturally positioned products across multiple retail channels shows that natural items also outpaced the greater segment’s growth, up 13.2% to $350.5 million as consumers increasingly seek clean, high-quality protein without artificial ingredients in a broader range of outlets. Even within the conventional marketplace, demand for natural protein powders is significantly increasing. Overall dollar sales of protein powders in the mainstream conventional multi-outlet channel was up 3.2% to $724.2 million, with sales for naturally positioned products climbing at a much faster rate of 17.2% to $196.0 million, while more conventionally positioned products remained relatively stable with a slight 1.1% decline to $528.1 million.

Natural Attributes and Ingredients Fuel Growth

As further evidence of consumer interest in clean-label protein powder products, label claims such as grass-fed, non-GMO, and organic showed significant growth over the past year, as well. Sales for protein powders labeled as grass-fed grew 92.3% to $21.6 million as grass-fed becomes a benchmark for quality and an important production standard regarding animal welfare to the natural consumer. Protein powders labeled as non-GMO grew 9.8%to $235.6 million, while products without labeled non-GMO ingredients were in decline. Certified-organic protein powders grew 33.7% to $136.9 million, and protein powders with any amount of organic content grew 8.2% to $220.7 million. While use of artificial sweeteners in protein powders is still prevalent in conventionally positioned products, sales for products in the segment that contain artificial sweeteners showed decline, dropping 14.3% to $255.6 million. Protein powders sweetened with stevia (a natural, zero-calorie, herbal sweetener) or alternative sweetener blends containing stevia grew 6.4% to $223.2 million.

Cultural Influences Bring New Consumers to the Segment

In addition to the natural consumer, other shopper groups are jumping at the chance to use protein powder to meet nutritional needs. “Health and wellness is quickly becoming health and fitness, led by a newer wellness community culture that recognizes the importance of exercise and fitness to overall health,” said Scott Dicker, client support lead and subject matter expert in sports nutrition at SPINS. “This movement drives dedicated fitness enthusiasts and weekend warriors alike to fuel efficiently for exercise and looks to protein for workout recovery and to reduce muscle soreness.”

Popular exercise trends such as CrossFit often promote dietary strategies as part of a lifestyle, bridging the gap between wellness and fitness verticals, and increasing demand for products that support specific ways of eating, such as paleo- or keto-positioned products. SPINS data show that paleo-positioned protein powders soared 55.7%, to $34.1 million, as the popularity of paleo and related ways of eating remain strong.

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