A rapidly growing category, digestive health ingredients are proving that their benefits reach beyond the GI tract.

According to the National Digestive Diseases Information Clearinghouse (NDDIC), 60 to 70 million people are affected by digestive disease. At the same time, the market is showing that the digestive health category is growing rapidly. In fact, in 2010, the total U.S. market for digestive health ingredients was valued at $265.9 million with an annual growth rate of 18.3 percent. Between 2010 and 2015, the market’s expected annual growth rate (CAGR) is 13.2 percent, with 2015’s expected revenue to reach $495.3 million.1 

Unfortunately, the standard American diet (SAD) is full of processed food and lacks many of the nutrients that the body needs. Because of SAD, a lack of exercise and stress, some Americans are facing gastrointestinal (GI) issues such as irritable bowel syndrome (IBS) or irritable bowel disease (IBD). “The consumer is concerned about poor diet, illness, stress and aging, all of which can impair the natural digestive process. The result is poor digestion and absorption of food that can lead to low energy levels, less than optimal growth and a less efficient immune function,” explained Jack Grogan, CN, chief science officer for Michigan-based Uckele Health & Nutrition. “Worse, the buildup of undigested or poorly digested foods can lead to fermented carbohydrates, rancid fats and putrefied proteins remaining in the digestive tract. These waste products can be toxic and have the potential to be absorbed into the blood stream, leading to health issues that could include compromised immune function.” 

In addition to IBS and IBD, digestive distress can be linked to food intolerances such as celiac disease or lactose intolerance. The Centers for Disease Control and Prevention (CDC) reports that about 50 million Americans are lactose intolerant, while according to the National Institutes of Health (NIH) one out of every 133 Americans (about three million) have celiac disease, and between five and 10 percent of people suffer from a gluten sensitivity in some form.

“There are a growing number of digestive disorders such as IBS, celiac disease, lactose intolerance, gastroesophageal reflux and ulcerative colitis in the general population,” said Anurag Pande PhD, vice president of scientific affairs for Sabinsa Corporation in New Jersey. “Some of these concerns are related to food intolerance such as lactose intolerance and celiac disorder. We avoid the use of potential allergens in the manufacturing of our products, and all materials used in the manufacture of Sabinsa’s ingredients are properly labeled to help people identify the right products and avoid any potential allergen.”

Overall Health 

Hippocrates, the father of modern medicine, once said that, “All disease begins in the gut.” Today, scientists refer to the gut as the body’s “second brain” as more than half of the body’s nerve cells are located there. Further, approximately 70 percent of the immune system is located there, protecting the body from viruses and bacteria. “The market for digestive health supplements is growing partially due to the increasing awareness among consumers between the important links between our digestive system and the immune system, thus creating a new positioning platform for not only digestive health, but immune health products,” said Doug Reyes, sales and marketing manager for Embria Health Sciences in Iowa.

There is also a direct connection between the digestive system and the brain, as the GI tract is sensitive to emotion. According to Uckele’s Grogan, the digestive tract’s smooth operation is vital to optimal energy and mood. “Studies show that physical, mental, emotional or environmental stress can unquestionably have an effect on gastric discomfort, causing very noticeable physical indicators that manifest around the digestive tract,” he explained. “The physical reason why the GI tract is extremely responsive to stress is because it is highly sensitive and full of Nerves, just like the brain. In fact, the GI tract is sometimes called the little brain—it’s the largest area of nerves outside the brain.” 

As consumers begin to grasp how important it is to maintain a healthy digestive system, they are looking for products to aid them in the process. However, while they can identify beneficial digestive ingredients, they may not exactly be able to explain what they do or how they do it. According to Neelesh Varde, senior product manager of fibers and proteins for Illinois-based Roquette America, there is a lot of consumer confusion with a number of the products that target digestive health.

“Research shows that more than half of customers are familiar with the terms ‘probiotics’ and ‘prebiotics.’ But less than half of them can describe what the terms actually mean,” Varde said. “Another problem is that consumer perception about an ingredient can be a great barrier. For example, many consumers equate fiber to a laxative or something consumed to relieve constipation. We know that fiber is much more important than that.”

Digestive Ingredients 

While there may be a bit of confusion among some consumers about what some ingredients for digestive health do, among the most trusted and relied upon include probiotics, digestive enzymes, prebiotics and fibers. “Gut flora is now recognized to be very important for general health—every ingredient or solution that is able to impact gut flora will be efficient,” explained Elodie Ruffin, probiotics sales and marketing manager for Wisconsinbased Lesaffre Yeast Corporation. “Fibers and probiotics are efficient to impact gut and they are strongly supported by many scientific studies to demonstrate their properties for digestive health.” 

According to Sabinsa’s Pande, probiotics promote gut health by promoting the survival of good bacteria, but noted that the delivery system can make all of the difference. “Most probiotics do not survive at room temperature for very long and hence they require a cold chain to be maintained throughout their lifetime,” Pande explained. “Fortunately for Sabinsa’s LactoSpore, a cold chain requirement is not needed as the bacteria, which is in spore form, can withstand heat and pH conditions quite effectively and has a room temperature shelf life of two years.”

Sabinsa’s LactoSpore consists of Bacillus coagulans spores. These spores are a dormant form of the bacteria and can resist the high temperature and low pH conditions as in GI tract. LactoSpore helps to attain a good microflora in the gut.

The company has also launched LactoWise, which can be considered as a second generation of LactoSpore. It contains both the probiotic (LactoSpore) and prebiotic part (Fenumannan) for better performance of the probiotics. Sabina also offers DigeZyme, which includes a mixture of five digestive enzymes that can aid in better digestion, as well as help people cope with lactose intolerance, according to the company.

Prebiotics are also gaining more traction in the digestive health category as research is showing the benefits of combining probiotics and prebiotics in the gut. According to a study published in 2012 in the Journal of Parenteral & Enteral Nutrition, researchers at the University of Illinois found that adding probiotics and prebiotics to the diets of pediatric patients with intestinal failure could replace intravenous feeding. “Prebiotics have been a relatively small slice of the digestive health pie,” said Embria’s Reyes. “The ability of EpiCor to deliver prebiotic-like effects in a relatively small does (500 mg/day) makes it an attractive alternative to prebiotic fibers, many of which require much larger efficacious doses.” 

Embria began producing EpiCor in 2007, yet the fermentation technology behind the production of EpiCor was originally created by Embria’s parent company for its animal feed products, which deal largely with digestive/feed optimization issues of the animal. A 2013 published paper in the Journal of Agricultural and Food Chemistry addressed EpiCor’s prebiotic activities and possible protection against inflammation.

Uckele recently reformulated its Oligo-Supreme, a highly viable, pure blend of pre- and probiotics that help maintain a healthy balance of GI flora to support healthy digestive, immune and GI health, according to the company. “At Uckele, we feel very strongly that a probiotic product that delivers multiple strands of pre- and probiotics is preferable to single-strand products because each strain has a purpose,” said Grogan. “Each one thrives in a different part of the digestive tract and works in a different way. A quality probiotic supplement should include a wide array of Friendly strands of bacteria, such as Lactobacillus acidophilus, Bifido longum, Strepococcus lactis, as well as the prebiotics mannan- oligosaccharide.”

In addition to Oligo-Supreme, the company also offers digestive enzymes and fibers, and a new novel ingredient, the patent-pending Auradagex. A proprietary extract from a native species of goldenrod, Auradagex provides potent and highly effective support for GI health, as well as benefitting a wide range of internal organs and body functions, along with multiple unique properties that have never been identified in any other goldenrod extract before, according to the company.

“These properties are more potent and therefore more effective for specific uses and applications. Out of 1,000 goldenrod species screened, Auradagex was the only one to possess these properties,” explained Grogan. “In addition, the biotechnology that was engineered for the extraction process of this specific species is a trade secret, and this extraction process is essential to identifying and preserving Auradagex’s powerful properties.” 

Science & Safety 

Consumers demand a safe and effective product that delivers on its expectations, so manufacturers and suppliers must be able to demonstrate the credibility of the ingredients and the finished product to gain their trust. “With proven science and clinical studies almost becoming a necessity these days, demonstrating credibility and efficacy of ingredients is an absolute must,” said Roquette’s Varde. “As a B2B company, we focus mostly on demonstrating credibility to our customers, the manufacturers. However, on our product websites, we do have dedicated resources to explaining our products and how they work for consumers.” 

Roquette’s most successful digestive health ingredient is a range of fibers under the brand name NUTRIOSE. The NUTRIOSE brand includes soluble-corn and soluble-wheat fibers. NUTRIOSE Fiber is non-genetically modified, natural and sugar-free. It is also a low-calorie ingredient, which is essentially invisible, as it provides no sweetness or taste. In addition, Roquette has had more than 20 clinical studies on NUTRIOSE published in peer reviewed scientific journals and the papers are available on the company’s website (www.nutriose.com). 

Lesaffre’s Ruffin added that consumers want an efficient and convenient solution that can help their digestive disorders quickly. “They also want to have a safe solution that is sciencebased to help them be confident in the finished product and the ingredients,” Ruffin said. “Today, it’s really important for a market to be based on strong scientific data to demonstrate the safety and efficiency of the ingredients.” 

Lesaffre’s most successful digestive health ingredient is Lynside Pro SCB, which is very stable (three years), and has many studies that support its efficacy, according to the company. Its newest ingredient to support digestive health is Lynside Pro GI+, a patented, clinically tested, statistically significant improvement in abdominal pain and discomfort with a clear mechanism of action and efficacy after only two weeks of consumption, according to Ruffin.

As the overall health benefits of the digestive system are becoming common knowledge among consumers, they are, in turn, becoming more selective and careful about what they buy.

“Many consumers are becoming smarter about their purchasing choices. They’re actively reading labels and looking up ingredients to see how they work,” said Roquette’s Varde. “In terms of consumer acceptance, they want convenient and proven solutions that don’t have any negative side effects. In fibers, for example, we know that consumption of low amounts of certain types of low viscosity soluble fibers can lead to a lot of digestive intolerance problems. We’re starting to see manufacturers move away from these types of fibers and toward those that offer the same benefits without the possible negative impact on consumers.” 

“Digestive health is of the utmost Importance when it comes to maintaining general health,” concluded Sabinsa’s Pande. “The GI tract is the most important organ when it comes to supplementation. Good GI tract health can ensure that nutrients are absorbed well.”

References: 

1 U.S. Digestive health Enzymes, Prebiotics & Probiotics Market (2010-2015). Accessed 1/28/2013. Www.marketsandmarkets.com/PressReleases/us-digestive- health-ingredients-market.asp.

Long-Term Use of Common Heartburn & Ulcer Meds Linked to B12 Deficiency 

Long-term use of commonly prescribed heartburn and ulcer medications has been linked to a higher risk of vitamin B12 deficiency, according to a new study published in the Journal of the American Medical Association.

Left untreated, vitamin B12 deficiency can increase the risk of dementia, nerve damage, anemia and other medical complications, some of which may be irreversible. Stomach acid aids in vitamin B12 absorption; suppressing the acids can lead to the health-threatening vitamin deficiency.

Researchers examined the electronic health records (including diagnoses, pharmacy orders and laboratory results) of 25,956 adult Kaiser Permanente patients diagnosed with vitamin B12 deficiency in Northern California between January 1997 and June 2011, and compared them with 184,199 patients without B12 deficiency during the same time period.

This is the first large, populationbased study linking vitamin B12 deficiency to acid-suppressing medications, which are among the most commonly used pharmaceuticals in the United States. In 2012, about 15 million people received 157 million prescriptions for a class of anti-acid medications known as proton pump inhibitors (PPIs).

“Patients who took PPI medications for more than two years had a 65 percent increase in their risk of B12 deficiency,” said Douglas A. Corley, MD, PhD, a gastroenterologist and research scientist with the Kaiser Permanente Division of Research. “Higher doses were also associated with an increased risk, compared with lower doses. Kaiser Permanente’s electronic health records allowed us to look at what happens in the real world for these commonly used medications.” 

While physicians usually prescribe PPIs and a related class of anti-acid medications called histamine-2- receptor agonists (H2RAs), some are widely available over the counter without a prescription.

Among the 25,956 patients who had vitamin B12 deficiency, 12 percent used PPIs for at least two years, compared with 7.2 percent of the control patients. The impact of taking any daily dosage of H2RA medications was less pronounced but also significant: 4.2 percent of patients with B12 deficiency used these medications versus 3.2 percent of control patients.

“This research raises the question of whether people who are taking acid-depressing medications long term should be screened for vitamin B12 deficiency,” Corley said. “It’s a relatively simple blood test, and vitamin supplements are an effective way of managing the vitamin deficiency, if it is found.”

For more information, visit www.kaiserpermanente.org.