Call Us Toll Free (800) 688-5956

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.

Read The Full Article HERE

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.

Read The Full Article HERE

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.

Read The Full Article HERE

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.

Read The Full Article HERE

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.

Read The Full Article HERE

Certification Fatigue: Is it really a thing?

Yes, it is. No question. Just ask a few of your customers. It seems every month a new certification seal pops up. For the end consumer, excessive certifications are an alphabet soup of buttons and badges that make their eyes glaze over after a brief encounter with a digital or print ad, sell sheet or scrolling web page.

Do Certifications Add Value to Brands?

In moderation, certifications can add credibility and legitimacy to a brand offering. They also add an implied third-party endorsement, which matters greatly to end consumers. In the past decade, in particular, as transparency has become of greater concern for consumers and customers, certifications add a note of authenticity to a brand by assuring buyers the brand made the effort to validate for certain standards.

How Do Claims Differ from Certifications?

For many customers and consumers, the line between claims and certifications is increasingly blurred, mostly because marketers have invented their own terms and seals and wording that make it difficult to discern what is a legitimate third-party certification and what is “marketing speak.” Common claims include “no artificial ingredients,” “all natural,” “no high fructose corn syrup” or “clean label,” to name a handful. These can be marketing statements or claims, and while FDA, FTC or a class action lawyer might take offense to how a brand makes these assertions, most of them go unchecked without an agency enforcing compliance. Certifications are more formalized third-party endorsements with strict standards for compliance, such as USDA Organic, Non-GMO Project Verified or NSF certified. 

In terms of the role they play, claims primarily serve to address potential consumer concerns, dietary restrictions, or attract those on an elective diet regimen like ketogenic, paleo, vegan, gluten-free, etc.  Certifications serve to reinforce product or ingredient quality, and also to build trust and equity in the brand name.

What Causes Certification Fatigue?

Increasingly, effective marketing outreach has revealed (often the hard way) that when it comes to brand education, sometimes less is more. A target audience member only has so much time and attention to devote to a brand message, and the more information crammed into each point of contact, the more likely consumers or customers are to tune out or move on or delete or click “close.” Brands that “over share” are often not the ones that successfully engage consumers because, frankly, they are throwing way too much at an audience that likely doesn’t care.  Smart marketers are selective in what they share and where they share it. This applies to certifications as well. I would argue a stream of 10 miniscule certification seals or logos is dramatically less effective than three or four key certifications that mean something to the customers or consumers who buy or consider buying that brand.

In addition, detailed certifications don’t belong on the principal display panel (PDP) of a label. They belong on the brand’s website or literature where they can be showcased and explained. Because, let’s be honest, the majority of consumers likely can’t define what non-GMO means, and non-GMO and USDA Organic are commonly confused even though they are not at all the same thing. If all the money spent educating consumers about these big time certifications is producing lackluster results, it should cause concern about the other dozen claims and seals plastered all over every piece of marketing communication.

Read The Full Article HERE

Unravelling the gut-brain axis

Undoubtedly, one of the greatest scientific advancements in our lifetime, along with the sequencing of the human genome, is the profiling of the microbiome. Most people have heard the estimate that we are only “10% human” or that foreign bacterial cells outnumber human cells 10 to 1. New data shows that number is closer to a 50:50 ratio. More accurately, we are 50% human.1 The microbiota exhibits all the characteristics and metabolic activity to be officially categorized as its own “organ.”2   

However, our foreign bacteria have 100 times the genetic diversity and potential of our own DNA. This means they have 100 times the genes that can be flipped on and off through various stimuli, like interaction with each other, metabolites, toxins, exercise and diet.3 The genetic output of our microbial population includes the production of proteins that may signal our own genes to act, either turning them on or off.4,5 

In fact, our microbiota produce nearly 30 different kinds of neurotransmitters, identical to the ones we make in our brain; plus, they manufacture and mediate thousands of immune- or inflammation-modulating molecules.6,7,8,9 The far-reaching impact of our symbiotic relationship with our microbiota influences brain, heart and liver health; the development and etiology of allergic and skin diseases; metabolic efficiency; drug pharmacokinetics; and immune and digestive function.10,11 The ability to manipulate this population for our good is a major constituent of epigenetics and personized nutrition.12,13 

The gut is increasingly referred to as the “second brain.” The gut contains more than 100 to 500 million neurons, exceeding the number of neurons found in the spine.8,14,15

The brain is the manager and sorter of all the stimuli we receive from the outside world. We mainly think of this as what we hear, see and touch, but we forget about the vast amount of data processed via the gut.16 It is no wonder that we have long noticed gastrointestinal (GI) complaints associated with depression, anxiety, insomnia and many other diseases we previously thought of as solely “mental” illnesses.17,18,19 Conversely, for nearly a century, many gut diseases, like irritable bowel disease, were described as “nervous disorders.”

The two-way communication between the gut and the brain via the enteral nervous system (ENS) and the vagal nerve is called the “gut-brain” axis.20,21 Science is still elucidating the complex pathways of communication between the brain and the gut that include hormone signaling, microbial metabolite production and immune system activation.22,23 We already know that enteric nervous system hormones and peptides can make their way into circulation, and more importantly, cross the blood–brain barrier acting synergistically to regulate mood, cognitive function, stress, appetite and sleep.24,25

The communication via the gut-brain axis goes both ways. This is especially evident when stress is introduced. Even short-term exposure to stress can impact the microbiota community profile and lead to dysbiosis by altering the relative proportions of the main microbiota families. This dysbiosis in turn influences stress responsiveness, anxiety-like behavior and the set point for activation of the HPA stress axis.

Read The Full Article HERE

GMP standards evolve for supplement manufacturers

Supplement contract manufacturers are critical in the supplement industry as evidenced by the regulatory actions taken over the last decade. This decade of increased awareness for the element that best helps maintain a robust industry has dramatically changed the landscape. The implementation and enforcement of GMPs (good manufacturing practices) for dietary supplements is the impetus for this shifted landscape. That change continues even though what we are experiencing is a fermata relative to manufacturing scrutiny. This kind of pause in regulatory activity among contract manufacturers is temporary.

The first decade of de facto enforcement of the dietary supplement GMPs is complete. Contract manufacturers should not be getting warning letters detailing inadequate responses to inspectional observations regarding basic GMPs. Yet, warning letters continue to be issued to outlier companies that still cannot perform the basics.

Manufacturers that demonstrate quality and compliance in the industry must understand that the regulations detail “good manufacturing practices” not “perfect manufacturing practices.” While these regulations represent the minimum standard, they are not a complete definition of procedure, process or performance expected during daily operations. They are, however, subject to interpretation, and this is where the future lies.

While operation may run smoothly and fully comply with the regulations—based on past inspections and a lack of regulatory activity—more will be expected. Even without outstanding regulatory issues, contract manufacturers have opportunities for improvement or optimization. The status quo isn’t enough. FDA expects continuous quality improvement. The next rounds of inspections will delve deeper into the level of compliance outlined in GMP regulations, but also against FDA’s view and interpretation of them. Manufacturers can anticipate inquiries into how specifications are established and at what stage of manufacture are they applied. The next rounds of inspections will want to know how the identity of a dietary ingredient is affirmed through adequate testing. FDA will seek to understand the basis that a test method is scientifically valid. The next rounds of inspections will want to know more about the specifications for the identity, purity, strength and composition of the finished, packaged product. The devil will be in the details.

The common practice of exempting one or more specifications from testing at the finished product stage of manufacturing needs to be justified. That means controlled data and documentation. Details are needed on the identity of any blend of materials a contract manufacturer receives. Details are needed on the determination of critical control points exist within the manufacturing process.

Continual improvements in GMPs will be more closely evaluated in the laboratory area, if a contract manufacturer tests products itself or works with a contract lab. FDA will want to know how that laboratory is qualified, and the agency may note the location of the laboratory for follow-up.

Read The Full Article Here

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.

Read The Full Article HERE

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.

Read The Full Article HERE

1 2
ncl-made-in-usa
ncl-fda
ncl-gmp-certified

For more information call (800) 688-5956 or Contact Us for a Free Quote!

For a Free, NO HASSLE Consultation or Quote: Simply fill out the form below and Click Send. One of our friendly staff will reply to you promptly. Thank you!