Defining and Determining Efficacy

You may have heard the word “efficacy” and wondered exactly what that means as it relates to dietary supplements – beyond, of course, its literal definition which means producing a desired or intended result.

In dietary supplement terminology, showing an ingredient’s efficacy is not simply having a group of people take the product and testing the results. Various types or families of ingredients require specific tests to identify their unique structures that may serve as the active component, which will then be tested to see how it impacts specific structures or functions in the human body.

The key lesson here is that you cannot just go straight to formulation and plan on conducting clinical trials to determine effect. At minimum, the ingredient must meet the FTC demands of support by “good science,” which is not a single, clear standard.

To show the efficacy of an ingredient, the supplier must be willing to invest in necessary research and development of genetic analysis, in vitro testing and human clinical studies. There are some who believe that a single human clinical study is enough, but many suppliers perform multiple clinicals, either to establish new claims or for further validation of previous studies, or to determine how effective the ingredient may be for the same claim but in different population groups (eg, overweight middle-aged women versus overweight middle-aged men).

At Deerland, we first determine the structure of the ingredient. For enzymes, we analyze the amino acid structure. Probiotics necessitate genome sequencing, a laboratory process that determines the DNA sequence of an organism. This sequence reveals the activity of the various genes comprising the genome, how those genes interact, and how the various parts of the genome are coordinated. This is an essential first step in determining safety of the ingredient. For example, Deerland’s DE111® strain of Bacillus subtilis was genetically sequenced in partnership with Cornell University, and was found to contain no plasmids, deleterious genes or antibiotic resistant genes. Sequencing also reveals genes that may offer certain benefits. For example, the sequencing of DE111 showed that the strain contains genes that increase IgG and IgA (antibodies), which support immune health.

Next, we perform in vitro testing to determine how an enzyme or probiotic will function under physiological conditions. Depending on the enzyme or probiotic strain, this will include a variety of testing methods. For example, our ProHydrolase® was tested using gel electrophoresis to determine how quickly and efficiently the product could break down whey protein for fuller absorption of amino acids. The same method was used to determine Glutalytic’s effect on gluten digestion.

Based on the successful results of in vitro testing, we move on to human clinical studies. Our clinical studies are submitted to and approved by an Institutional Review Board (IRB) before they begin. A quality (reliable) study design is one that is double-blind and placebo controlled. (We have conducted human clinical studies on our branded products ProHydrolase®, DE111®, Glutalytic® and PreforPro®.) When the study is complete and the data has been analyzed, the study abstracts are submitted to applicable peer-reviewed journals for publication. Published studies allow the public to access the clinical results of the ingredient (and sometimes, a finished product/formula).

For a reputable, quality supplier, the efficacy investment doesn’t end. There are always more studies to perform and research to do.

Digestible Definitions for Enzymes & Probiotics

As we learn more about more about digestive health, we are empowered to improve our overall health and well-being. It’s a great feeling to take control of our digestive systems by providing the right mix of healthy foods and beneficial supplements.

To stay ahead of the curve, check out this quick guide to the terminology related to enzyme and probiotic supplements. You’ll be glad you found such an easily “digestible” glossary of terms!

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ATPrime: The Energy Molecule

Most people think “high-energy” foods are high in sugars, caffeine, or certain vitamins, but none of these by themselves is the source of true energy—that role belongs to adenosine triphosphate (ATP), the main energy “currency” of all living cells.

What is ATP?
ATP is the principal molecule for storing and transferring cellular energy. In fact, it is the most widely distributed high-energy compound in the human body. It is used by every cell to build complex molecules: it’s used to move muscles, and it’s a signaling molecule for many important processes such as digestion and metabolism.

Where is ATP?
ATP is produced in every cell of the body, and although it is manufactured in the body on a continual basis—age, exercise (weight training, sports), and other stressors can significantly deplete ATP. We can consume ATP through raw foods, like fruits, vegetables and nuts. Unfortunately, the average American diet consists of cooked foods devoid of ATP and important enzymes. This can result in gastric problems, since ATP influences gastric acid and pepsin secretions, mucus production, and contractility of the stomach. In other words, ATP is needed for timely, proper, and complete digestion of food.

Effects of Low ATP
Without sufficient levels of ATP consumed through our diets, the body must make all the ATP it needs, using its own energy and resources to do so. This puts the body into a constant state of short-term energy production, which is highly inefficient. As a result, people feel fatigue, hunger, and digestive distress. Low ATP can also weaken immune systems.

ATPrime™
A digestive supplement that provides ATP and enhances ATP production can help offset this deficiency. ATPrime is an ingredient that provides ATP without using the body’s energy and resources, supporting proper nutrient absorption.

For digestive health formulations, Deerland offers ATPrime as a complementary technology to enzymes and probiotics. Combining ATPrime with enzyme and/or probiotic formulations provides ultimate digestive support by decreasing the energy demand of the digestive process

To learn more about the importance of ATP and how ATPrime can improve your supplement product, contact us today!

Whitepaper: Probiotics For Sports Nutrition

A healthy gut and an improved immune system are key factors to help overtake the competition. The gut flora performs a variety of functions that are important for health. In fact, 70% of our immune cells are located in the digestive tract, making the health of the digestive tract critical to overall health. A healthy and well-balanced gut flora facilitates digestion, protects us from pathogens, provides vitamins and nutrients and helps form the immune system. For athletes and fitness enthusiasts, optimizing digestion and immunity are major factors as they strive to improve performance. Download this whitepaper to learn more about how Bacillus subtilis DE111 can give fitness enthusiasts and serious athletes the performance boost they’re searching for.

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GMO or Non-GMO? That Is the Question…But What’s the Real Answer?

A genetically modified organism, or GMO, is an organism that has had its DNA altered or modified in some way through genetic engineering. The answer to the question as to whether an organism has been genetically modified may depend on one’s definition. There are various processes through which an organism may be genetically modified, some resulting from very natural processes and some from the deliberate tinkering with the genome of the organism. Let’s take a look at some of these processes to get a better understanding.

Natural Selection is a natural process whereby an organism population may experience genetic change over multiple generations, due to environmental circumstances. For example, a microorganism can experience changes in its genome due to changes in its food supply, temperature of its environment, exposure to environmental toxins or competition from other organisms. This is a completely natural process, and it is happening all the time.

The rate of genetic change due to Natural Selection can be accelerated by deliberately exposing a population of a microorganism to conditions that may alter the genome, such as ultraviolet light. UV exposure can cause changes that may affect the organism on the genetic level. This method would be common when trying to increase the expression of genes that code for production of an enzyme protein or an antibiotic, for example. This is still considered to be natural, since it’s a random process and many generations must be screened for changes to be significantly affected. In the case of microorganisms, the result may even create a new strain of the species.

Genetic changes or “modifications” that occur as the result of Natural Selection do not result in what we would classify as a true GMO. Genetically modified organisms are living organisms whose genetic material has been artificially manipulated in a laboratory through genetic engineering.

Genetic engineering is the process of directly manipulating the genetic material of the organism. In order to do, this the entire genome must be mapped out and the function of each gene must be elucidated. Depending on the methods utilized to modify the organism, the result may or may not be classified as a Genetically Modified Organism.

There are two basic methods that are viewed differently in the United States and Europe. Insertion of DNA from another organism is clearly genetic modification, but under the European definition of a GMO, it is allowable to insert multiple copies of a native gene in order to increase expression of a trait carried by that gene. This is referred to as “self-cloning”, and as long as no foreign DNA is introduced, it is not considered to be a GMO according to the EU. However, that is not the case in the US, where self-cloning is considered a form of genetic modification, and classifies the resulting organism as a GMO.

So, as you can see, the answer to “Is it GMO?” often depends on your definition. What form of genetic modification has occurred, and was it due to natural processes or was it a result of actual insertion of genetic material either native or foreign? Understanding the differences will help you come to the right conclusion.

Probiotic Drinks Flourish in Today’s Functional Beverage Market

Rising numbers of consumers are reaching out for beverages that do more than just quench their thirst. Consumers are becoming increasingly health-conscious, especially the younger generations, driving a forceful demand for functional beverages to meet their needs. The growing trend of healthier, enhanced drinks is garnering a great deal of opportunity for companies to develop products that nourish as well as refresh and hydrate.

One way that many companies are turning their standard offerings into wholesome functional beverages is to include probiotics in their drink lines to set their products apart. However, when developing new probiotic drinks, one problem companies can run into is finding a substantial strain that can withstand their manufacturing processes. Bacillus subtilis is often a compatible solution because the microorganism’s tough outer shell allows it to withstand harsh processing, and is compatible with beverages ranging from juices to alternative milks. Probiotics like Bacillus subtilis promote the growth of “good” bacteria in the gut, offering the additional health benefits that today’s consumers seek out in functional beverages.

Innovation in the ready-to-drink industry used to mean renovated packaging and tactical marketing campaigns. Now, manufacturers have shifted their focus to redesigning the beverages themselves. Consumers today seek out drinks which perform a function ─ drinks that target health conditions, naturally provide an energy boost, or even that replace entire meals. Market research reveals that millennial-aged consumers are willing to spend more money to receive these better-quality refreshments.

Demand specifically for probiotics in functional beverages is now higher than ever. According to EcoFocus, 46% of grocery shoppers are actively looking for beverages that contain probiotics. Of the many probiotic strain options that manufacturers can choose from when designing beverages, Bacillus subtilis is frequently the best choice available. Researchers at Deerland Enzymes have developed one strain of Bacillus subtilis called DE111® that is especially stable under many conditions. DE111 homogenizes well with almost any liquid, remains viable within a wide pH range, and can be incorporated into dry mixes. This makes it suitable for sparkling waters, juices, milks, powdered drink mixes, sports drinks, and other applications that less-hardy probiotics would be unable to tolerate─ and market research supports probiotic use in these applications.

The water, fresh juice, and sports drinks sectors are all currently growing as more consumers eschew sugary soft drinks. Milk remains a highly-consumed beverage, with alternative milks, popular among younger consumers, showing the most sales growth. The demand for healthier beverages continues to call for innovation, and functional beverages are now sweeping the market. Still, since many beneficial ingredients like probiotics can lose their efficacy in processing or have a limited shelf life, finding the right blend of ingredients to transform a standard beverage into a functional one is no easy feat.

Functional beverages will continue to grow in popularity as consumers reach for healthier drinks and turn away from sugary options. As these consumers continue to learn about the benefits of probiotics, they drive the demand for probiotic functional beverages. Redesigning consumer-favored drink choices like water, juices, energy drinks, and milk alternatives to promote improved digestion and overall health is possible using Bacillus subtilis DE111.

To learn more about Deerland Enzymes and Probiotics, and Bacillus subtilis DE111, please visit http://deerlandenzymes.com/de111/.

Trends Driving the Supplements Market to Soaring Heights

Nowadays, people are centering themselves around healthier lifestyles. Apps that track nutrition and electronic wearables that record physical activity are helping individuals meet their fitness goals. The plethora of information available on the internet also arms consumers with knowledge they can use to make healthy choices. As a result of these factors, the market for dietary supplements is experiencing tremendous gains.

It’s estimated that over two-thirds of American adults consume dietary supplements, generating $121.6 billion to the US economy. Fitness and sports enthusiasts are huge market contributors, and are expected to generate revenues of $37.16 billion by 2024. As premature births around the world rise, market observers predict that supplements formulated to reduce malnutrition will grow 9.5% between 2016 and 2024. Overall, experts at Grand View Research forecast that the supplement market will reach $278.02 billion by 2024, as consumers increasingly turn to these aids to optimize health and performance.

As individuals look to combat obesity and the ill-effects of being overweight, they are steadily seeking to improve their digestive health, priming this related-sector for growth. The digestive health supplement market includes probiotics, prebiotics, and digestive enzymes. The probiotic segment is experiencing rapid growth due to the increasing amount of research and discovery around the microbiome and the effects of gut bacteria on many levels of our health, even beyond digestion. Prebiotics help modulate the microbiota and enhance mineral absorption, while digestive enzymes break down macronutrients into smaller components to facilitate efficient absorption.

The sheer amount of data available on the internet, along with the nutrition/exercise tracking abilities of technology, are causing consumers to become more aware of their physical health, and what they should and should not be putting into their bodies. Many consider dietary supplements to be essential to promoting better wellness. Older individuals, in particular, spend a lot of money on health-related goods, and are likely to turn to dietary supplements as they age. Today, supplements are available in a variety of forms including traditional capsules, gummies, soft chews, granules, and liquids, providing many attractive options to consumers entering the supplements market.

An aging population, better awareness of nutrition and self-care, and the increasing variety of dosage formats are all factors taking the dietary supplements market to greater heights. These trends are creating excellent opportunities for products designed to promote digestive health. Deerland is a leading specialty formulator and contract manufacturer of enzyme and probiotic-based dietary supplements. To learn more about the probiotic and enzyme market, browse our Markets Breakdown blog topics.

Don’t Underestimate the Power of the Brand

You’re investing in a branded ingredient – use it to its fullest!

Take a look at this picture:

If you are at a party and the dark-soda choices were either Coca-Cola® or this, which one do you predict would remain untouched?

This is representative of the generic products that were frequently found next to brand name counterparts in the late 1970s. “No frills” saved consumers a lot of money, but also frequently lowered quality of experience. Since then, “generic” anything is still linked with poorer quality.

And if you use a branded ingredient but don’t take full advantage of the identity package its maker offers, this is what consumers think your product contains – “no frills” ingredients. When you add up all the attributes that differentiate branded ingredients—uniqueness, clinical support, regulatory status, formulation expertise, marketing dollars—you get quality. Why not get the most out of your investment by using the brand name and/or logo on the bottle or packaging?

Products formulated with branded ingredients possess a differentiating factor that proves a company’s commitment to transparency. Consumers are very savvy and immediately turn to the internet and social media to research products. If your product contains Deerland’s DE111® B. subtilis, for example, consumers who already know about DE111 are more likely to trust the quality of the product and buy it when they see it on your label. And make no mistake, more consumers are taking the time to scrutinize labels and materials related to your product. Self-education is extremely empowering, as it increases confidence in decision-making. And if the resulting experience with your product is deemed positive, you then have achieved a loyal consumer.

Conversely, consumers who may not be aware of the branded ingredient but who see it on your package may be compelled to investigate via the internet. Additionally, there is prestige associated with a branded ingredient; the consumer believes that the product using that brand is more effective and of higher quality than a competing product that has a generic counterpart.

For example: A sports nutrition product geared toward healthy and effective muscle building, featuring “ProHydrolase® protease enzyme blend” on the label is more intriguing and attractive to your prospective consumers than simply “protease.” A piqued consumer will find – quickly – that ProHydrolase has a solid foundation of research, including two human clinical studies. He or she can also learn quite a bit about what it is, how it works, and its value for fitness. Further, they will learn about Deerland’s integrity and commitment to safety and ethical practices – which will directly be associated with your brand and product.

When you partner with a supplier of branded ingredients, you are reassuring your potential customer base that you take quality and safety seriously, that your commitment to ensuring a positive experience is absolute. Think of it this way: when a product works, it’s a terrific feeling – on the other hand, “no frills = no thrills.”

Whitepaper: A Pet Project – Supporting Digestive Health in Companion Animals

According to the American Pet Products Association, more than 97 million U.S. households own at least one dog or cat. Americans will spend more than $70 billion this year on pet supplies and care.

The pet health supplement market is predicted to show continued growth as pet families want their dogs and cats to have the same preventive health options as they do. Download this whitepaper to learn how enzymes and probiotics help support digestive health for our furry friends.

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Whitepaper: Cultivate Your Success – How to Choose the Right Manufacturer for Your Probiotic Supplement Product

To take full advantage of the growth of the probiotic market, brand owners need to meet consumer demands for transparency and accountability—which is easily accomplished when partnering with the right manufacturer.

The retail value of the U.S. probiotics market is expected to climb 38 percent by 2021. Because they are living organisms, probiotics have unique handling needs at every stage of the manufacturing process. Some of these include environmental controls, batching, blending, packaging, storage and shipping. This whitepaper outlines key considerations for choosing a contract manufacturer that has expertise producing probiotic supplements.

  • Building construction, layout and monitoring are key components of environmental control.
  • About 30 steps are needed to properly turn probiotic material into a viable supplement.
  • Onsite testing and third-party verification contribute to quality control and assurance.

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