Digestive health is a tricky health concern to wrap your arms around. On the one hand, about 70 percent of the cells necessary for the immune system to function effectively are connected to the gastrointestinal tract. Accordingly, probiotics are looked at for their general health-promoting properties.
But digestive health is more than immunity. It includes a range of concerns from diarrhea to irritable bowel syndrome (IBS) to lactose intolerance. Intestinal bacteria serve an important role by inhibiting pathogen growth through production of antimicrobials, enhancing tight cellular junction and intestinal wall barrier function, priming dendritic cells and the immune system, assisting in digestion and breakdown of micro-nutrients from otherwise undigestible material and synthesis of short-chain fatty acids; synthesizing key vitamins such as vitamins K and B, and exerting anti-inflammatory effects.1,2
(For the record, probiotics as well as prebiotics have been found to have systemic effects such as reduced severity of colds or other respiratory conditions, allergy incidence and symptoms, as well as effects on the oral cavity and vaginal tract.3)
Trouble is, U.S. food law did not anticipate the emerging research showing that foods and supplement-style ingredients (read: probiotic bacteria) can play a role in reducing the risk of acute conditions. Just ask Nestlé; it was sanctioned for its BOOST Kid Essentials Nutritionally Complete Drink, which contained probiotics and enjoyed a study showing reduced incidence and duration of colds and flu among children who consumed its product. Nestlé simply promoted the study results on its Web site – and FDA said it's an unapproved drug claim and had the company remove that language from its marketing.
Even Dannon studied its DanActive withLactobacillus casei in 638 preschoolers. After three months, those drinking the yogurt had 19 percent fewer common infectious diseases. Bzzt – drug claim!4
Lactobacillus GG (LGG) – the most-studied probiotic strain ever, supplied by Chr Hansen – has hundreds of studies showing, for instance, reduced gastrointestinal-tract infections and reduced respiratory-tract infections.5
Danisco supplies its HOWARU line of probiotics with Bifidobacteria animalis lactis Bi-07, which shows reduced cold and flu symptoms in children.6
Another strain in its HOWARU line demonstrated lactose-intolerant children had decreased symptoms after consuming dairy products with its probiotic compared to controls.7
Ganeden Biotech's BC30 probiotic is notable for its nine published studies in the last two years. The spore forming bacteria has a protective layer, which makes it able to survive food-processing conditions such as heat and pressure, as well as digestion, so the strain ends up exactly where it can provide the mosthealth benefit. This opens up many more food possibilities than your standard yogurt delivery system, in which the probiotics are placed in at the end of the yogurt production process.
In one double-blind, placebo controlled clinical trial with 44 subjects, the BC30 probiotic group experienced statistically significant improvements in abdominal pain and bloating for patients with IBS.8
Other published studies on BC30 show improvements in patients with post-meal intestinal gas-related symptoms like distention and flatulence, as well as diarrhea-related IBS symptoms. 9,10
A 2008 meta-analysis concluded that BC30, LGG and Saccharomyces boulardii were most effective in preventing antibiotic-associated diarrhea.11
Chr. Hansen is the world's largest supplier of probiotics, most of which are backed by published clinicals. Its BB-12 strain was shown to help geriatric patients with constipation, as well as act as a prophylactic against traveller's diarrhea.12,13
UAS Laboratories supplies Multi-Flora Probiotics, which contain 12 billion colony forming units (CFUs) using the strains L. acidophilus DDS-1, B. longum, B. bifidum and B. lactis. A 2010 study at the Mayo Clinic on 25 patients with IBS found significant improvements after 60 days of treatment, with 84 percent of patients showing significant improvement in abdominal pain, 74 percent in bloating, 92 percent in belching, 88 percent in flatulence, 91 percent in diarrhea and 87 percent in constipation. No clinically evident side effects were observed.14
Lastly – but certainly not least – is the fact that not all probiotics are created equally. This case was made in a 2007 study that compared five commercial probiotic products in cases of children's diarrhea. Researchers found that LGG and a combination of four species (L. bulgaricus, Streptococcus thermophilus, L. acidophilus and B. bifidum) were effective, but ineffective were Saccharomyces boulardii, Bacillus clausii and Enterococcus faecium SF68.15
Nebraska Cultures also markets the DDS-1 strain under the Dr. Shahani's brand name. Dr. Khem Shahani first isolated the strain more than 40 years ago at the University of Nebraska (DDS stands for Department of Dairy Science strain 1), and the company, now run by his sons Michael and Robbin Shahani, guards as a trade secret their father's methods of culturing and stabilizing the strain. A recent, yet-to-be-published study by Prof. Robert Hutkins of the University of Nebraska assessed the persistence of common probiotic strains, including DDS-1, in the human gut. The study concluded that regardless of strain, probiotic organisms do not colonize the gut, and therefore, regular supplementation is needed for them to be consistently present in the digestive tract.
The lesson here for marketers is to consult with your R&D staff to make sure your product has the right strain, and the right dose (at the end of shelf life and not date of manufacture, thank you very much) to match the specific health benefit you are pitching.
So if you are precluded from saying anything, what can you say?
Culturelle, the consumer packaged good-product containing LGG, claims the product "restores the natural balance of good bacteria in your digestive tract." DanActive claims, "helps strengthen the body's natural defenses." BioGaia says, "reduces colic, improves digestive health and function and boosts immunity."
"In all of these you have no idea about the health end point as demonstrated in the published literature," says Mary Ellen Sanders, Ph.D., president of Dairy & Food Culture Technologies consultancy. "It's getting harder for companies to substantiate benefits of these products. And there's no mechanism for companies to communicate to doctors. FDA says you can do this on a drug but not a food."
Worse, there's a fear that, because probiotics are so effective, the FDA could categorize probiotics as biologics, which would put them in a whole new regulatory class that could quash the entire market.
The fact remains that the next five years should see an explosion of growth of research in the safety and efficacy of different cultures at different levels to different health conditions. Perhaps even enough to make it catch up to the market, which continues to grow rapidly.
The synbiotic concept – that is, combining probiotic bacteria with prebiotic fibers that act as feedstock for probiotics – has a lot of merit. Europe has led the way in getting the synbiotic concept off the ground as the EU launched the Syncan study, which aimed at studying the effects of prebiotics such as chicory inulin and oligofructose with probiotics in cancer treatment.
Prebiotics modify not just the composition but also the metabolic activity of probiotic bacteria in the gut. Beneficial effects include improving bowel habits and mineral absorption, modulating lipid metabolism and the immune system by slowing down pathogen growth, and decreasing pathogen colonization in the gut and retarding the process of carcinogenesis.16
In the area of cancer, one rat study found oligofructose as well as the long-chain inulin (provided by Beneo) exerted protective effects at an early stage in the onset of cancer.17 Another rat study demonstrated the anticarcinogenic effect of prebiotics and synbiotics but not of probiotics.18
Other researchers studying rats found that, against the background of a diet with a level of fat typical of a Western diet, L. acidophilus and inulin exerted a protective effect against colon cancer.19
A prebiotic like inulin is a true multi-tasker. Beyond operating as a food source for probiotics, food companies are seeing multiple benefits of using prebiotics. For one, they are a low-calorie sweetener source, which makes them useful for reduced-sugar products. Also, inulin can stabilize water into a viscous structure with the same mouthfeel as fat – so not only can it help with high sugar content of products, but also high fat content. Triple bonus: all the while maintaining a smooth, creamy texture. Formulators should note that while inulin is good, you have to get the dose down correctly, as too much can have bad effects on texture.
Finally, inulin is also increasingly being used to boost calcium absorption, especially in dairy foods because dairy has a natural affinity in consumers' minds with calcium content. "Inulin has been shown to improve calcium absorption in some studies, though not in others," said calcium researcher Robert Heaney, Ph.D., from Creighton University in Nebraska.
Only three things are truly zero-calorie: air, water and insoluble fiber. Fiber is the most beneficial compound adults are looking for, according to research conducted by the International Food Information Council.
In 2005, fiber's fortunes were fired up when the Dietary Guidelines for Americans and MyPyramid.gov recommended that adults consume more fiber-rich foods, such as fruits, vegetables,and whole grains. The U.S. Institute of Medicine recommended 19 to 38g of fiber per day, depending on age and gender, with at least three daily servings of whole-grain foods. However, the average American consumes only about 14g of dietary fiber per day. The 2010 guidelines were not released by press time, but fiber is already a known commodity, and formulators are busy integrating both soluble and insoluble forms into a variety of food formats.
Health claims are allowed for oat (cholesterol reduction), barley (heart disease) and psyllium (heart disease). Dietary fiber is also known to reduce post-meal blood-sugar levels. Moreover, water-soluble fibers, such as psyllium, moderate post-meal glucose and insulin concentrations in noninsulin dependent diabetic patients, if taken with meals, and also can reduce body weight and hypertension.20
"There is no doubt that the amount of fiber in a diet controls the amount of bulk, controls transit time, and determines whether the individual will suffer from chronic constipation," explained Abram Hoffer, MD, Ph.D., and Andrew Saul, Ph.D., in Orthomolecular Medicine For Everyone (Basic Health Publications, 2008). "People on food that is high in fiber have a very low rate of bowel cancer. With a long transit time, it is more likely that carcinogenic chemicals will be formed."
Enzymes break down food macromolecules – protein, carbohydrates, fats – into their smaller building blocks. Protease enzymes break down proteins, amylase enzymes work on carbohydrates and lipase enzymes digest fats. In the body, enzymes are manufactured by the pancreas.
"These enzymes increase the level of digestion in the stomach, increasing the amount of food broken down," instructs EnzymeUniversity.com, an educational website produced by enzyme supplier NEC. "Therefore, less undigested food is passed into the colon, and food nutrients are more available for absorption."
Enzymes can help with conditions associated with poor digestion, including lactose intolerance and celiac disease – the diagnosis for those medically seeking a gluten-free diet. In one study, cereal enzymes were able to diminish the toxic reactions of celiac disease in intestinal epithelial cells in vitro.21,22
In a double-blind, crossover study, researchers gave 18 subjects pancreatic enzymes after a typical high-calorie, high-fat meal. Subjects were studied for the next 17 hours. Those who took the oral enzymes had significantly reduced bloating, gas and fullness during the entire period, as well as during the dinner-to-bedtime period. Researchers speculated that the pancreatic supplements could also be beneficial in IBS.23
One human study with 1,242 patients with colorectal cancer found those taking enzyme supplements for nine months had an improvement in the signs and symptoms of the disease.24
Probiotic products to consider
It's a combo of probiotics and enzymes, though at lower levels of these two ingredients because company researchers found enzymes tend to eat probiotics.
Medical food, with 50 billion CFUs per fresh-bottle serving. Excellent scientific dossier, but needs a better marketing plan to break into the shopper outside of hospital settings.
Phillips Colon Health
Synbiotic approach uses three probiotic strains – L gasseri, B. bifidum and B. longum combined with inulin prebiotic to support the growth of the proboitic strains.
Yogurt is the winning delivery system, though food companies like Dannon do a disservice by not stating exactly how many probiotics are put into the product.
This juice-based functional drink proves that dairy does not have to be the delivery system of choice. Taste: check. Dosage: check. Marketing: Hip and savvy – check.
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