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Digestive health: a critical pathway to wellness: research continues to inform and improve nutraceutical product development.

Often indicative of overall health, digestive wellness appeals to a broad group of consumers. Natural products that assist or support digestion continue to standout in the marketplace, and as ongoing research unlocks the mysteries of how microorganisms living in the gut impact health, long-term prospects for targeted solutions appear promising.

Broad Health Impact

A balanced gut microflora helps the body to digest food in a variety of ways, noted Shaheen Majeed, marketing director, Sabinsa Corporation, East Windsor, NJ--for example, by helping in the secretion of digestive enzymes, assimilation of nutrients, hormone regulation, excretion of toxins, etc.

Many health conditions that significantly impact quality of life stem from poor digestive health, said Mr. Majeed. "The gut is sometimes referred to as the 'second brain' owing to its impact upon the health of various vital organs of the body. Much of this is controlled by the gut microflora, which relates to wider aspects of health such as cognitive or brain health, obesity and even metabolic health."

The digestive system is essential for the maintenance of overall health, said Paul Altaffer, CIO, RFI LLC, Blauvelt, NY. "It is how we metabolize and absorb nutrients that sustain us, as well as how we eliminate waste and toxins."

John Deaton, PhD, vice president of technology, Deerland Enzymes, Kennesaw, GA, noted that, according to the

American Gastroenterological Association (AGA), good digestive health describes a system that inlu appropriate nutrient absorption, intestinal motility, immune function and a balanced microbiota (the community of microorganisms that live in the gut).


"Research over the past two decades has revealed that gut health is critical to overall wellness and immunity, and that an unhealthy gut contributes to a wide range of health challenges," said Dr. Deaton. "I've seen the evidence of this in my own research, through clinical studies on our various products designed to support digestion. Our studies have shown that numerous health conditions beyond digestive discomfort can be affected when digestion is optimized with the aid of a dietary supplement--for example, reduced frequency of headaches or even general physical pain."

Many researchers believe that supporting digestive health and restoring the integrity of the gut barrier will be one of the most important goals of health professionals in the 21st century, he added/'The gut microbiome is one of the most exciting areas of science today, and the relevance of the microbiome to our health beyond digestion is a hot area for research. The continuous developments in the study of the microbiome open up new and exciting opportunities for nutraceutical products that influence the gut flora, such as prebiotics, probiotics and enzymes.

According to Anke Sentko, vice president of regulatory affairs and nutrition communication, BENEO, Morris Plains, NJ, understanding of digestive and gut health has evolved over time."It was long believed that the job of the large intestine (colon) was to preserve water and get rid of waste products, while only the small intestine provided our body with energy and essential nutrients. But this perception has changed. What goes on in the dark, oxygen-free (anaerobic) content of our colon is now believed to be key to our health and well-being."

The relationship between the intestinal microbial population (microflora) and health has received significant scientific attention of late, she added. "Data suggest that the composition of the colonic microflora has important implications for our body function and health. A healthy local microflora supports our gut barrier function and prevents pathogenic microorganisms from colonizing the intestinal mucous layer or even invading the body. Our defense and immune system, which is also very active in the intestines, depends on bugs that do not even form part of our body."

While most people understand the importance of digestive health generally, many still don't realize the effect it has on other functions of the human body, said Mike Bush, president, Ganeden, Cleveland, OH, and executive board president of the International Probiotics Association (IPA)."For example, 70% of our immune system is located in the digestive tract, meaning that digestive health also affects immune health. Studies using our GanedenBC30 probiotic have also found a connection between digestive health and protein utilization, muscle recovery, vitamin and mineral absorption, along with a variety of other benefits--all confirming the importance your digestive system has on overall performance and health."

Kevin Mehring, president and CEO, UAS Labs, Wausau, WI, also acknowledged that digestive health is vitally important to overall well-being, affecting a wide array of bodily functions, including immunity, metabolic activity and the production of vitamins. "In addition, the gut bacteria play an important part in the preservation of the gut barrier function. Digestive health and the bacteria that inhabit the digestive tract are largely responsible for the critical functions of the body's immune system."

Additionally, new research has demonstrated the importance of digestive health to brain function and overall mental health, Mr. Mehring added. "Technically known as the enteric nervous system, or ENS, this'second brain'consists of some 100 million nerve cells that line the entirety of the digestive tract. The main role of the ENS is to control digestion and help us 'feel' the inner workings of our gut. In doing so, it communicates with the brain regarding the overall health of the body's gut and its immune system, and plays an important role in determining our mental state."

Improper digestion can lead to a range of health problems, including weight gain or loss, constipation, diarrhea, loss of energy, acne, eczema, yeast infections and fungal infections, said Michael Shahani, COO, Nebraska Cultures, Inc., Walnut Creek, CA. "One of the most important areas of research right now is looking at the connection between the gut (digestive system) and the brain. It is now known that digestion affects cognitive function and overall mental health more directly than was ever thought before. An improper balance of good and bad bacteria in the gut is responsible for many ill effects."

Amanda Brown, sales representative at American Laboratories, Inc, Omaha, NE, noted the overall importance of digestive health, saying, "If your body is not digesting food properly then that can lead to other health issues, like Irritable Bowel Syndrome (IBS), which causes stomach pain and discomfort, as well as Gastro-esophageal Reflux Disease where stomach acid backs up into the esophagus."

Research suggests that a disruption in the microflora of the GI tract, called dysbiosis, creates an undesirable immune response and related chronic inflammatory conditions, noted Sue Hewlings, chief science officer, IgY Nutrition, Oklahoma City, OK.

"Dysbiosis is defined as a shift in the microbiota composition resulting in a decrease in the number of beneficial microbes accompanied by an increase of harmful microbes in the intestinal tract," she said. "There is a connection between dysbiosis and immunity. Research indicates that 70-80% of the immune system originates in the GI tract. Addressing GI tract health and any potential dysbiosis is the place to start in improving overall health that therefore automatically addresses the underlying cause of so many conditions.

Fulfilling Consumer Needs

An estimated 70 million people in the U.S. experience digestive issues, Ms. Hewlings added, and more consumers are becoming aware of the connection between good nutrition and digestive health.

Once a relatively small market catered to consumers with serious health conditions like IBS, digestive health products have quickly evolved into a broad, general health category, noted Mr. Altaffer. "Almost all consumers today are concerned with their digestive health in some capacity, because it is essential to overall health. From support to serious health issues to common digestive discomfort like bloating and gas, digestive health is on the minds of most consumers. This is compounded by the quickly evolving eating habits of people and their sensitivity to certain foods. All of this should lead to a major, long-term trend that will fuel product development and innovation for a long time to come."

Today, a wide range of consumers are focused on their digestive health, and there are many challenges to combat, said Sabinsa's Mr. Majeed. "The stressed and unhealthy lifestyle so common today often undermines digestive health. Food consumption patterns tend to change erratically in terms of the quality of food consumed, and hectic schedules disturb the nutrition intake schedule that the body is used to. Environmental pollutants and seasonal changes also cause an imbalance to gut microflora or enzyme production in the gut. A very common side effect of consumption of antibiotics or immunosuppressants is diarrhea, which is caused by destruction of gut microflora and requires the supplementation of probiotics or enzymes to put things right."

People suffering from specific food intolerances also may find improvement with digestive health supplements, he added. "There is a huge market for digestive health supplements that have been clinically validated for their safety and efficacy."

In terms of consumer appeal, Ms. Sentko pointed to BENEO research that suggested 61% of U.S. consumers are concerned about maintaining digestive health and 43% are looking for products to actively improve digestive health. "Unsurprisingly, people suffering from constipation or other digestive issues are interested in products supporting a healthy digestive system. However, next to medical drivers, wellness and well-being are becoming increasingly important reasons for consumers buying products supporting digestive health."

Additionally, Mintel research has shown that between 2013 and 2015, 16% of functional claims globally were related to digestive health, making it one of the most important functional claims, Ms. Sentko said.

Probiotic Appeal

The probiotics market has benefited from increased consumer awareness and additional research detailing their health benefits, said Nebraska Cultures' Mr. Shahani. "In today's market, having results from human clinical trials is becoming more and more important. Women seem to be the group most interested in probiotics for themselves, their children and their families."

In the past two years, the market for probiotic products has increased dramatically, he added, predicting continued growth. "Many people are just now being educated as to the benefits of probiotics, and we feel that, in light of the current economic situation, people are looking to find ways to stay healthy as opposed to waiting for illness to send them to a medical professional."

The number of probiotic products on the market has grown considerably, and consumers have more choices than ever before, he added. "However, there have been a number of ineffective products due to over-marketing and poor delivery systems. So it is important to educate consumers to look for well-researched, legitimate products."

The more probiotic raw materials are processed, the more likely they are to lose viability and potency. "While probiotics are susceptible to moisture and heat, it is possible to design probiotic products that will survive without refrigeration for a few months at least," Mr. Shahani noted. "Putting probiotics in convenient dosage forms such as capsules and sachet packs is a convenient way to make these supplements easy to take."

According to Ganeden's Mr. Bush, recent consumer surveys have demonstrated demand for probiotic-fortified foods and beverages across almost all age groups and demographics."Among those who are aware of probiotics, 98% of respondents said they would buy a food or beverage product that contained a health benefit if priced the same as a similar product without health benefits," he noted."It was also found that 57% of healthy consumers would pay 10% or more for food or beverage products containing probiotics."

Different health benefits resonate within varying consumer groups, he continued. For example, immune benefits are important to parents for children's products, protein utilization and muscle recovery for athletes, overall digestive health for seniors, etc.

"One factor driving demand from consumers is an interest in convenient foods and beverages containing health benefits that can be easily incorporated--or are already included--in their daily diets," said Mr. Bush. "Previously, due to stability and survivability, probiotics were not able to be added to products outside of refrigerated dairy--meaning consumers had to eat dairy or take a supplement to obtain the benefits. However, thanks to the spore-forming characteristics of GanedenBC30, a probiotic can now be added to other foods and beverages, opening up endless possibilities for the probiotic market and making it easier than ever for consumers to get their daily dosage."

The "secret" behind GanedenBC30's survivability is a layer of material within the cell that protects the organism's genetic core, which makes it highly stable and allows it to remain viable through most manufacturing processes, three years of shelf life and the low pH of stomach acid, said Mr. Bush."Once the organism reaches the gut it sheds its protective spore coating and germinates and multiplies to provide the benefits we have studied."

The benefits and efficacy of GanedenBC30 have been shown in 24 peer-reviewed clinical trials published in major journals, he added."Ganeden is a science-based company and we continue to be on the forefront of probiotic research. Our ingredients and partner products go through rigorous testing to ensure the stability, efficacy and benefits. We feel that ongoing studies will show additional health benefits of GanedenBC30 and further confirm the impact of our probiotic strain on overall wellness. The microbiome is incredibly complex and unlocking the secrets it holds may be the key to many incredible discoveries, and we are currently looking at how GanedenBC30 interacts with and affects the microbiome."

Probiotic-containing products present unique challenges to manufacturers, according to Mr. Mehring of UAS, and, ultimately, format affects function. "The stability of probiotic cultures is often significantly diminished prior to administration as a result of moisture, oxygen or acid environments. Capsules or tablets incorporating freeze-dried microorganisms prolong shelf-life dramatically, especially with added protectants."

Probiotics taken orally must also circumvent passage from the mouth to the intestine, he continued. "Physiological conditions such as stomach acid, mechanical stresses, digestive enzymes and bile acids can provide an effective barrier against entry. Choosing probiotic strains with the ability to survive and thrive in such environments is an important step in product development. In some cases, the use of acid-resistant capsules can further promote the ability of probiotics to reach their site of action in high numbers."

Sabinsa's Mr. Majeed said that probiotics, alone or in combination with prebiotics, enzymes from natural sources, certain plant secondary metabolites such as curcuminoids, flavonoids, etc. all support gut health.

For example, the company's LactoSpore is a shelf-stable lactic acid-producing probiotic ingredient that is Generally Recognized As Safe (GRAS) and has been clinically substantiated for its safety and efficacy to improve gut health.

LactoSpore (Bacillus coagulans MTCC 5856) has also been approved by Health Canada for its potential to help relieve abdominal pain associated with IBS. A clinical study on subjects suffering from IBS reported that symptoms associated with the disorder were alleviated with the use of LactoSpore. This included a significant decrease in clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency, Mr. Majeed noted.

LactoSpore has been found to be stable in juices, syrups, baking confectioneries and frozen foods, according to the com pany. "Owing to its encapsulated spore-forming nature, LactoSpore is resistant to most chemical and physical conditions (e.g., heat and acid) that may be a part of food processing," said Mr. Majeed. "This property of improved shelf stability makes it relatively easy for inclusion in different foods."

Another popular format, probiotic gummies, or soft confectionery, are making a major splash throughout the industry, he added.

Fiber & Prebiotics

In addition to probiotics, research has indicated that consumers are focused on healthier lifestyles with particular interest in natural fiber, said BENEO's Ms. Sentko. "Consumer research results show a clear preference for natural products--with as many as 47% of respondents actively seeking natural fibers--and 45% considering non-GMO products as 'better.'"

In 2015, U.S. consumer research commissioned by BENEO and conducted by HealthFocus International revealed that 93% of consumers associated fiber as an important ingredient for digestive health, she noted.

"Market research figures also show that almost one out of two U.S. consumers associate prebiotics with a healthy digestive system. Particularly appealing for consumers is that prebiotics improve a body's function naturally. They like the idea that prebiotics help the body support a natural process. This is also why claims such as 'naturally keeps your digestive system healthy,' or 'supports your body to maintain its normal digestive processes in a natural way/ are very attractive to consumers."

Scientific studies have proven the prebiotic effect of BENEO's natural chicory fiber for all ages, she added. "Being soluble and having a mild sweet taste, BENEO chicory fiber inulin and oligofructose are easily incorporated into a wide range of food and beverage products while maintaining or even improving taste and texture."

To date, more than 150 high-quality human intervention studies for inulin and oligofructose are available, Ms Sentko said. "These studies deliver strong evidence for distinct health benefits, including digestive health (prebiotic effect, bowel function), weight management (eating less, naturally), blood glucose management and bone health (calcium absorption)."

Understanding about chicory root fiber as a proven prebiotic continues to increase, she said. For example, the positive effect of chicory root fiber to support regularity by increasing stool frequency received a health claim in the European Union exclusive to BENEO. "A structure/ function claim is also used in the U.S. to support digestive health and well-being," she added. "The prebiotic fermentation with its bacterial break down products (SCFA) and metabolites are part of the mechanism behind a natural stimulation of the bowel motoric."

Additional consumer insights in the U.S. have shown that more than 60% of respondents regard applications such as breakfast cereals, cereal bars, bread and yogurt as very appealing to provide digestive health benefits. "Consumers are aware of the beneficial effect fibers have on digestive health but the majority of U.S. consumers have difficulties reaching the recommended daily intake of fibers, which is 25 grams/day. This is why fortified products that can be easily integrated into the daily diet are increasingly in demand."

According to Scott Turowski, technical sales, Sensus America, Inc., Lawrenceville, NJ, research has shown that digestive health is linked to immunity and overall well-being. There are also strong indications that the make-up of a person's gut microbiota is related to weight management. "Consumer research we have conducted indicates that younger consumers have a greater interest in digestive health than other age groups. At the moment, this is being driven by a greater interest in dietary fiber and the fact that these consumers are increasingly seeking out products that provide it."

Mr. Turowski also pointed to chicory root fiber as an ingredient that has performed particularly well in this area. "Strong clinical research has demonstrated its effectiveness as a prebiotic fiber that will increase the levels of good bacteria in the gut. In addition to its health benefit, chicory root fiber delivers functional benefits that allow it to replace sugar and make it easy to formulate with."

While dietary supplements have become an increasingly popular way to deliver dietary fiber, better-for-you snacks, such as nutrition and granola bars, have also been a strong category for products related to digestive health, he added.

Other Digestive Aids

While some consumers experience specific symptoms of poor digestive health and consequently look for products that target those issues, there are also consumers who are looking for products that can be taken daily as preventive, precautionary digestive aids, noted Ms. Brown at American Laboratories.

"A good overall digestive product works in a wide range of pH environments and has enzymes that target different applications, she added. "Pancreatin is a naturally occurring enzyme that works as an overall digestive product. This enzyme contains protease, amylase and lipase to break down proteins, starches and fats. It can be used in different formulations for a great digestive health product."

Another naturally occurring enzyme, pepsin is a proteolytic enzyme that breaks down proteins in low pH environments, she continued. "This allows the enzyme to withstand the low pH of stomach acid and continue to work further along the digestive track."

In terms of application-specific formulas, there are products that target the breakdown of gluten, for example."American Laboratories, Inc has an enzyme formula called GlyproZyme that contains enzymes to target gluten digestion within the body specifically. Cellulase is a fungal-based enzyme that is used in formulations to help break down the cell wall of plants. This is used in formulas for consumers who eat a large plant-based diet to aid in healthy digestion."

According to Deerland's Dr. Deaton, most consumers who incorporate enzymes into their supplement regimen are well educated--they invest a lot of time researching the products that are best for them)--brand loyal, and typically lead healthier and more active lifestyles.

"Because our bodies' natural ability to produce digestive enzymes declines as we age, enzyme supplements are also a popular choice to aid in digestion for the increasingly popular 'healthy aging7 market. Enzyme supplements continue to gain recognition among consumers for their role in digestive health and bioavailability of nutrients from foods. The ability to break down food into its basic and useful components is of critical concern for consumers interested in functional nutrition for growth, development and supporting healthy aging."

The role of digestive enzymes is to break down food-derived fats, carbohydrates and proteins into smaller sub stances that can be used by the body, Dr. Deaton added.

"Although the body produces its own digestive enzymes, it may not be enough to completely break down cooked or processed foods. During cooking and processing, the natural enzymes present in raw foods are denatured. In addition, our bodies don't produce the enzyme cellulase at all; this is an enzyme that breaks down the cell wall of plants, releasing the nutrients for our bodies to absorb. Those who follow a vegetarian or vegan diet are likely missing out on key nutrients from the plant-based foods they're eating, and would most certainly benefit from an enzyme supplement."

"Deerland Enzymes takes pride in the science-supported, enzyme-based formulations we develop for digestive health," he continued. "Although we specialize in customized formulations, we have also developed an exclusive line of university-studied products to offer to our customers, which can be used as-is, or the basis for a custom formulation."

Ms. Hewlings, at IgY, said that while probiotics provide beneficial flora, prebiotics may offer an alternative or symbiotic benefit as they have been used to stimulate beneficial bacteria to help to restore balance. In contrast to the probiotic action, which provides living microorganisms, prebiotics stimulate the activity of healthful bacteria.

The company's IgY Max is a polyvalent antigen specific product from specifically immunized eggs that targets 26 of the most common human-relevant pathogens, said Ms. Hewlings. "It supports the role of prebiotics by aiding in immune system function and by decreasing 'bad' bacteria while leaving the good intact. IgY Max is a unique digestive and immune function ingredient that promotes GI health by increasing gut wall integrity, improving bowel function and reducing non-beneficial bacteria adherence. In addition to favorably altering the composition of the microbiome, IgY Max supports the digestive tract lining, promotes proper microbial adhesion, supports immune system health, supports the body's natural defenses and promotes proper cytokine balance. Moreover IgY Max is able to exert its activity within the entire length of the GI tract. Due to its mechanism of action IgY Max is an effective tool to address issues caused by dysbiosis."

Digestive health is a major area of interest for product development at RFI, according to Jeff Wuagneux, CEO and president. "Part of the trend we see evolving is consumer interest in whole food, minimally processed and clean label products. Therefore, we begin with our whole food ingredient platform that focuses on offering whole, minimally processed fruits, vegetables, cereal grasses, algae and so on. Whole foods may also contain prebiotic fiber and other macro-nutrients that are sometimes lost in complex extracts. These ingredients fit nicely with digestive formulas as a base."

Similarly, RFI offers its FermaPro line of fermented whole food ingredients. Mr. Wuagneux said the FermaPro line of fermented ingredients is intended to make common fruits, vegetables, spices and botanicals more digestible and more nutrient available. "Fermentation contributes many potential benefits to the gut health-interested customer. These may include reduced carbohydrate and sugar content, improved nutrient profiles, reduction in 'anti-nutrients,' improved digestibility and bioavailability of nutrients."

RFI also offers Benegut, a water extract of Perilla frutescens leaf that has demonstrated ability to support healthy digestive function, including acting as a prebiotic agent, improving microflora as well as supporting regularity, said Mr. Wuagneux. "In addition, in vitro and human clinical studies were performed with Benegut that demonstrate it has anti-spasmodic and anti-inflammatory effects and helps support some digestive distress like bloating, gas and abdominal discomfort."

RFI specializes in the development of powdered beverage applications, capsules/tablets and other powder delivery forms. "We see these as ideal delivery systems for digestive products. The ingredients and formulas we develop are well suited for these applications," said Mr. Wuagneux.

Conclusions & Prospects

As the market moves forward, clinical research validating the benefits of nutritional ingredients and products will progress, and likely appeal to consumers. Specifically, experts pointed to further understanding of the gut microbiome as an intriguing area for further research.

"We've always found it interesting and rewarding when traditional medical knowledge, sometimes going back thousands of years, is confirmed by modem research," said Sabinsa's Mr. Majeed. "Most of the ancient medical systems, such as Ayurveda, place much emphasis on healthy digestive function because of its impact on the entire body. Modern research is finding more evidence that digestive function is linked to many other systems of the body."

IgY's Ms. Hewling said she expects to see continued development in scientific methodologies and in defining exactly what a healthy microbiome looks like. "I expect to see continued research on the connection between the microbiome and its human host at the genetic and molecular level, and how this is impacted by nutrigenomics and other aspects of host environment. This will lead to improved development of products to support the development of a healthy microbiome, which will in turn positively affect health and potentially longevity."

According to Mr. Mehring at UAS, with a growing interest in nutrition and personal fitness, health conscious consumers are more interested in overall well-being and vitality than ever before. More research will serve to inform their wellness habits."We expect that more and more research into the role of gut microbiota on all aspects of human and animal health will show that not only are probiotic bacteria essential for life, but that manipulation of the gut microbiome may become the next step in conquering many diseases and disorders."

Researchers continue to learn more about the differences in microbiome composition between healthy people and individuals with disease, such as metabolic or inflammatory ailments, he added. "These investigations are leading to more human studies to help pin these differences down in greater detail. Ongoing research should help better address whether microbiome changes are a cause or a consequence of disease. A better understanding of the microbiome should also result in the discovery of tools, including probiotics or prebiotics, to modulate the microbiome toward a healthier state."

According to Deerland's Dr. Deaton, the gut microbiome is "one of the most exciting areas of science today," and rapidly advancing technology has allowed researchers to learn more about individual microorganisms and their implications for overall health. Recent research on the microbiome has shown that its influence extends far beyond the gut, playing a crucial role in both digestive and immune systems. "A particularly fascinating area of study is in fecal transplants, whereby the microbes from a healthy individual are transplanted to an individual with a health issue caused by reduced amounts of the necessary (good) bacteria."

He continued, "The continuous developments in the study of the microbiome open up new and exciting opportunities for nutraceutical products that influence the gut flora, such as prebiotics, probiotics and enzymes."

This article in a nutshell:

* Broad Health Impact

* Fulfilling Consumer Needs

* Probiotic Appeal

* Fiber & Prebiotics

* Other Digestive Aids

* Conclusions & Prospects

By Sean Moloughney

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Author:Moloughney, Sean
Publication:Nutraceuticals World
Date:Oct 1, 2016
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