A newly published human clinical study demonstrates the efficacy of the bacteriophage (phage) cocktail PreforPro® in favorably supporting the gut microbiota and systemic markers. PreforPro is patented for use as a prebiotic.
The study, PHAGE Study: Effects of Supplemental Bacteriophage Intake on Inflammation and Gut Microbiota in Healthy Adults published in Nutrients, is a randomized, double-blind, placebo-controlled crossover intervention trial involving 43 participants aged 18 to 65.
According to the researchers, the goal was to determine how daily consumption of supplemental phages (PreforPro®), influences the gut microbiota of healthy adults with self-reported gastrointestinal distress. In addition, the team sought to determine effects of phage ingestion on microbial production of short chain fatty acids (SCFAs) as well as if phages alter both lipid metabolism and markers of local and systemic inflammation.
The team found that 28-days of PreforPro consumption favorably modified several bacterial species, including increased populations of the genera Eubacterium, one of the most abundant genera in the healthy human gut. Additionally, the researchers saw a reduction in the circulating pro-inflammatory cytokine Il-4, which is correlated with autoimmune and allergic responses. According to the authors of the study, these data highlight the potential of bacteriophages for selective modification of targeted microbial species without inducing dysbiosis.
In conclusion, according to the authors, “bacteriophage consumption caused minimal disruption to the gut microbiota but did elicit minor changes which may be viewed as beneficial overall…and increases in fermentative taxa capable of butyrate production suggest a shift towards a healthier gut environment.”
This human clinical study on PreforPro further validates observations in prior in vitro and mouse studies, which showed enhanced growth of a broad spectrum of probiotic species including B. breve, L. acidophilus, L. paracasei, L. casei, L. rhamnosus, Lc. Lactis and B. subtilis. Further, these effects were seen after only five hours after PreforPro administration.
“Ingesting probiotics are only half the healthy gut microbiome equation; effective prebiotics are the other half that encourage resident beneficial bacteria to populate,” says John Deaton, vice president of science & technology for Deerland Probiotics and Enzymes. PreforPro is unique in that it is a bacteriophage that is patented for use as a prebiotic, and it’s attractive for consumers who are concerned about starch consumption and having to take large doses – as PreforPro is a non-starch/fiber compound that exerts its prebiotic abilities in a small, 15mg dose.”
Delivering supplements in standard plastic bottles is a time-tested and familiar way for manufacturers to supply products to consumers. But with so many options and brands available today, it’s important to look for ways to differentiate a brand and stand out from the crowd. Alternative packaging is one way to differentiate products on retail shelves, and stick packs are one of the most exciting new options available.
Stick Packs are Perfect for Consumers On-the-Go
Stick packs are available in a wide variety of sizes and configurations. Generally, they take the form of a small pouch, packet, or tube made from a flexible film, so they are easily opened, portable, and can be consumed virtually anywhere. The product is typically prepared for direct consumption and provides the complete recommended dose in a single serving. Stick packs are available for powdered products, and sometimes even those in liquid form. A sports drink powder, for example, may be more desirable in a stick pack rather than in a jar or bottle because customers can take the product with them and easily mix and consume it exactly when and where they need it. Best of all, with stick packs, a single product can be delivered in an assortment of flavors rather than just one, offering consumers choice and variety.
Stick Pack are also Good for the Environment
Consumers’ desire for ease-of-use is driving a number of trends including single-use products, on-the-go consumables, and blister packs for pills and capsules. Stick packs address each of these needs. However, as society becomes more concerned with environmental and sustainability issues, brand owners are trying to reduce their carbon footprint. Packaging companies are facilitating eco-friendly processes through the use of responsible materials, recycled or recyclable products, switching from one standard pack-type to another with an improved footprint, trimming waste and reducing package weight. Stick packs improve sustainability since they typically use less material than the majority of single-serve or convenience packaging.
Partnering with the Right Packaging Manufacturer is Essential
Many brand owners are attempting to lessen their manufacturing impact on the environment by outsourcing packaging, but it is essential to partner with an experienced firm. Because most powders will begin reacting as soon as they come into contact with moisture, it is essential to package and seal the product in a controlled production environment.
Deerland Probiotics & Enzymes delivers contract manufacturing services for science-backed enzyme and probiotic-based formulations. As a start-to-finish provider, we offer stick packs, as well as encapsulation, tableting, coatings, bulk powder, labeling and bottling in a safe and sanitary environment. To learn more about our production and packaging capabilities, visit https://www.deerland.com/services/production/.
Digestive issues are not an anomaly. On an average day 70,000,000 people experience some type of digestive issue. You might be one of them.
There are many factors that impact digestive health and overall health. Your gut hosts an entire ecosystem of bacteria that help with digestion. Good bacteria, and bad. It’s important to have a a balanced microbiome, as it helps facilitate digestion and provides the vitamins and nutrients for a viable immune system.
But often diet alone is not enough. What you feed your body can have a great impact on your gut and digestion, and prebiotics have the potential to help.
Prebiotics support the growth of beneficial probiotic bacteria that promote a healthy digestive tract. Watch Lori’s story below to learn how a prebiotic, PreforPro, helped regulate her digestive problems.
PreforPro is a novel prebiotic that helps restore microbiome balance by crowding out bad bacteria, so good bacteria have room to grow. It aids in your digestion and helps maintain overall health. Working in both the large and small intestine, it’s clinically proven to influence the microbial population of the gut, yielding benefits for systemic health. Discover a better prebiotic with PreforPro today.
Did you know that your gut health is connected to many aspects of your overall health? It’s a very complex part of the body with 100 trillion bacteria—more than in any other part of the body. This group of bacteria is known as the gut microbiota, and they have become a particular focus for researchers who are aiming to learn exactly how this system influences and even improves health.
Gut Microbiota is Unique for Every Individual
About 1,000 different species exist in those trillions of bacteria, representing around 5,000 specific strains. With so many kinds of bacteria, all guts are unique, but certain combinations have been found in the healthiest individuals. There are a variety of factors that impact a gut, including age, diet, genes, the environment, and medications.
What Gut Microbiota Does
Gut microbiota has several different roles in the body. It metabolizes nutrients from the food you eat and the medications you take. It also serves as a barrier against intestinal infections, and produces vitamin K, which is a building block of blood-clotting proteins. These factors are now known, but gut microbiota may do even more. Research, mostly involving animals, suggests it could be associated with overall health. The challenge is determining which actual species or strains have these unique properties.
Latest Findings Signify Microbiota is the Most Important Part of the Gastrointestinal System
New developments have been made in the study of microbiota. Two studies from the Mayo Clinic infer gut bacteria could predict if a person is more susceptible to rheumatoid arthritis (RA). Additionally, it could be a means to determine the best treatment for the condition. Researcher Veena Taneja, Ph.D. published two studies related to the subject in Genome Medicine and Arthritis and Rheumatology. The Genome Medicine published study reports that researchers were able to isolate specific bacteria that that had high populations in RA patients, while finding they were low in healthy individuals.
Cardiovascular and heart health are additional body systems connected to gut health. A study published in the Journal of Applied Microbiology links gut microbiota and gut permeability to the vascular system. In experimentation with mice, reduced levels of A muciniphila increased the likelihood of arterial plaque buildup. The findings also suggested that dietary prebiotics could increase the abundance of A muciniphila, thus decreasing plaque buildup and the resulting inflammation.
Microbiota Communicates with the Immune System
Another positive impact of balanced gut health is how the microbiota communicates with the immune system. There have already been discoveries about the relationship, and they are laying the foundation for possible future applications. More trials of probiotics and prebiotics is necessary to reach this possibility.
Probiotics Encourage Good Gut Health
The gut flora is important to a variety of the body’s functions with 70% of the immune cells located in the digestive tract. This means that gut health is essential to overall health. A healthy, well-balanced gut flora helps with digestion, protects from pathogens, delivers vitamins and nutrients, and is part of the immune system. To reap the benefits of good gut health, probiotics are vital.
Probiotics are those bacteria referred to as “good” or “beneficial.” Probiotic bacteria may be consumed in foods or supplements. When consumed through food or supplements, probiotics are able to thrive in the intestinal environment and provide benefits that aid in digestion and support normal bowel function. Learn more about probiotics and how they impact gut health by checking out this Probiotics 101.
A new study has found that athletes who consumed a probiotic daily may benefit by boosting immunity and recovery following strenuous training or play by reducing levels of tumor necrosis factor-alpha (TNF- α), a pro-inflammatory compound. The study, called Effects of Probiotic (Bacillus subtilis DE111) Supplementation on Immune Function, Hormonal Status, and Physical Performance in Division I Baseball Players was recently published in the journal Sports.
Athletes and fitness enthusiasts work hard to improve their health and conditioning. However, they sometimes have issues with their digestion and immunity even as they strive to improve their physical performance. The probiotic strain Bacillus subtilis DE111 can help give fitness enthusiasts and serious athletes a performance boost.
The Sports Nutrition Market is Growing Rapidly
Sports nutrition is the leading projected growth sector in global healthcare, far outpacing other areas such as OTC, vitamin and dietary supplements, and weight management. A recent report by Zion Market Research estimates the global sports nutrition market will grow about 8% annually over the next few years, reaching over $45 billion by 2022. The category includes products such as sports drinks, meal replacement drinks, protein powder, nutrition bars, and dietary supplements that are consumed by professional and amateur athletes to improve their overall health, performance, and muscle growth. Typical goals of a sports nutrition program include muscle and strength building, weight loss, cardiovascular improvement, increased energy, and better sleep.
Athletes May Suffer from Digestive Issues
Despite their typical healthy appearance, athletes may suffer from a number of digestive issues. In facts, studies show that 30% to 50% of athletes and up to 93% of long-distance triathletes suffer from gastrointestinal problems. These issues can occur before, during, or after an exercise session or a competition. Gastrointestinal issues can impair performance or recovery by causing electrolytes imbalance, sleep disturbance, and dehydration. Additionally, a recent study of a group of ultra-marathon runners found 89% experienced nausea, 44% had abdominal cramps, and 44% suffered from diarrhea.
Probiotic Supplements Can Help Ease Gastrointestinal Issues in Athletes
Probiotic supplements boost athletic performance many important ways. First, they help optimize digestion by increasing the absorption of nutrients and digestion of protein, providing the building blocks for muscle building and recovery. Probiotics accomplish this by maintaining levels of healthy bacteria in the gut that aid in the digestion of macronutrients, allowing for optimized nutrient uptake from food. Next, they help strengthen immunity by increasing the absorption of antioxidants making athletes less susceptible to sickness and infection. Finally, they minimize common GI issues, decreasing the occurrence of athlete’s diarrhea, gas, bloating, and heartburn.
Studies Show DE111 Probiotic Can Help in Sports Nutrition
The probiotic strain Bacillus subtilis DE111 from Deerland Probiotics & Enzymes is a spore-forming strain that helps provide a competitive edge to athletes. For example, in a study on the effects of supplementation during offseason resistance training in female Division I athletes, DE111 produced significant improvements in body composition when consumed in conjunction with a high-protein recovery drink. It also helped improve lower body strength as determined by the deadlift 1-repetition maximum. In a separate study on the effect of DE111 on the daily bowel movement profile for people with occasional gastrointestinal irregularity, DE111 helped improve gastrointestinal discomfort including constipation and diarrhea. Participants also reported an increased frequency of normal type stools compared to those in the placebo group.
The DE111 strain is genome sequenced for safety, remains viable under wide temperature range, and survives passage through the acidic environment of GI tract to help crowd out bacterial pathogens and maintain healthy gut barrier function. To find out more about how DE111 can help in sports nutrition, download this white paper.
Now that you have the perfect formula to add to your product line, what dosage form should you choose for delivery? Capsules, tablets, softgels, powder or liquid? During the development process for a new dietary supplement, besides the choice of active ingredients, it’s important to consider the final dosage form. The dosage form is not only important for how the product will ultimately be presented to the consumer but also may have critical influence on the formulation itself due to technical, efficacy and shelf life constraints.
Fortunately, there are a variety of dosage delivery options across supplements and plenty of new technologies and trends in the industry.
Powders and Liquids: Mixing it Up
Traditional forms such as tablets and capsules along with powders and liquids require different packaging and storage conditions to deliver safe and efficacious products while still appealing to shifting consumer trends. When deciding which supplements are best suited to an individual’s needs, in addition to overall product quality, it is essential to consider how delivery form may impact usability, stability and shelf life. Otherwise, you end up with products that harden, oxidize, taste bad, mix badly, change color, or even become rancid. Certain ingredients, for example, mix best in powder form. Protein or other nutrients that do not require exact measurements are especially well-suited to powder formulas. The downside is that powder sitting in water over time can cause microbial growth, making it dangerous to consume. Liquids are another option, especially for a quick, no-hassle way to take a supplement. However, liquid formulations limit the amount of active material available in a serving and are not ideal for bad-tasting substances. Popular dosage forms are diverse and expanding with consumer preference.
Tablets, Capsules, and Softgels: All in Good Taste
Capsules are perfect for almost any product needing a highly precise dosage measurement or for those with a bad taste. Tablets can also deliver a precisely measured dose and offer a similar breakdown time to capsules: about 20 minutes. However, it is possible to scientifically manipulate dissolution time by coating capsules in ingredients targeted to certain delivery specifications. Softgels offer an effective delivery form for liquid or oil-based formulas. Available in different sizes and colors, the contents are typically suspended in oils, making softgels and ideal delivery form for lipid- and fat-soluble nutrients such as efficacious oils, fatty acids, fat-soluble extracts or fat-soluble lettered vitamins. Innovative capsule-in-capsule technology makes it possible to combine both powders and liquids into a single dosage form, creating new opportunities to have incompatible ingredients play well together to deliver added benefits not previously possible.
Powders in Stick Packs: Easy-to-Swallow Innovations
Powders in stick packs, or sachets, are gaining popularity. These new technologies have been developed partly in response to issues of swallowability. Other dosage forms or delivery systems are seeing increasing interest to avoid the “pill fatigue” issue that seems to be trending. Powders in Stick Packs and liquids in “shots” seem to be gaining ground in the market due to their convenience and portability for today’s on-the-go lifestyle.
Important Considerations for Supplement Dosage Forms
Quality will always be a key consideration in choosing wellness supplements. However, efficacy and bioavailability are critical as well. Depending on the dosage form, one may have to rethink formulation requirements to accommodate the attributes needed. For example, flow and compaction characteristics, particle size and solubility all must fit the purpose for solid dosage forms. Add to those taste and appearance characteristics for those forms that will be consumed in powder or liquid forms and formulation issues can become much more complicated. Shelf life requirements are also a major consideration that should not be overlooked in the choice of ingredients, dosage form and packaging format. After all, the best ingredients in the best dosage form hold little value to the consumer if they do not deliver the best quality and efficacy at the stated expiration date on the label.
As a start-to-finish provider, Deerland Probiotics & Enzymes delivers contract manufacturing services for science-backed enzyme and probiotic-based formulations. Learn more here about the manufacturing capabilities of Deerland Probiotics & Enzymes.
In September 2018, the FDA issued a draft guidance on how to label supplements containing live microbials. The announcement presents the organization’s “intent to exercise enforcement discretion to allow supplement companies to use colony forming units (CFUs) when declaring the quantity of live microbials on a Supplement Facts Label.”
Why the Guidance Was Issued
The new guidance comes in response to a widespread disagreement over the use of the weight of ingredients versus colony forming units (CFUs). The new guidance does allow manufacturers to incorporate CFUs; however, weight must still be included on the label, and listed in order of predominance by mass quantity.
Despite the fact that the FDA believes “CFUs provide a useful description of the quantity of live microbial dietary ingredients,” it rejected a petition from the International Probiotics Association to list ingredients only by CFUs rather than weight. While disappointed that the FDA denied the petition, the IPA still considers the new guidance a victory in promoting the use of CFUs. Although weight, which has proven to be an inaccurate way to measure microbials, will continue to be a requirement, the addition of CFUs in live microbial labeling provides consumers with more information to choose the best product for them.
FDA Will Allow CFU Labeling, But Supplements Must Meet 7 Requirements
The FDA will permit CFU labeling of microbial dietary ingredients provided the following requirements are met:
- The quantity is first listed in terms of weight.
- The declaration of quantity in CFUs is expressed in a manner that is clearly separate and readily distinguishable from the weight, e.g., as a parenthetical or in a subset line.
- The declaration of the quantity in CFUs is formatted in clear terms that can easily be understood by a common reader, e.g., 10 billion or 300* (where the unit that “*” is intended to represent is a typical measurement of CFUs, and is clearly indicated elsewhere in the Supplement Facts label).
- The declaration of quantity in CFUs is accurate and not misleading, does not render misleading other aspects of the Supplement Facts label, or other aspects of the product label.
- The declaration of quantity in CFUs measures only live microbial ingredients and does not include inactive, dead, or nonviable organisms.
- Live microbial dietary ingredients in a proprietary blend are listed in descending order of predominance by weight; and
- The product label otherwise complies with all applicable laws and regulations.
Scientists Prefer CFUs to Measure Live Microbials
CFUs are the scientifically accepted unit of measurement for probiotics. Rather than painstakingly counting every cell individually under a microscope, scientists dilute a sample of microbes and spread it across a Petri plate, allowing them to count groups of microbes, called colonies, with the naked eye. However, each CFU doesn’t necessarily correspond to a single microbe. But if the cells stick together in lumps or chains, the CFU instead refers to these groupings. Each colony is assumed to have grown from a single colony-forming unit, or CFU.
CRN Commends Guidance but Has Reservations
Another group advocating for CFU usage is the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry. While the news of the draft guidance was indeed hopeful, they worry it doesn’t go far enough. Like the IPA, CRN’s main concern is that weight, which must still be included in labeling, isn’t an accurate measurement for determining live microbial counts in products.
CRN thinks the FDA is heading in the right direction but cautions that a “dual listing of ingredient quantity in weight and CFUs presents conflicting product labeling information and puts responsible industry members in an untenable position.”
Why This Matters to Supplement Companies
At present, the FDA is garnering much feedback on their draft guidance, opinions which may alter their current stance that weight must be included in supplement labeling. Deerland Probiotics & Enzymes wants to ensure that the industry stays abreast of regulatory changes. By subscribing to our blog, Digestible, you can remain current with market trends and regulatory developments that affect how the supplements you sell must be labeled, and the best way to communicate any changes with your customers.
DE111 Probiotic Provides Benefits for Body Fat Percentage and Athletic Performance, According to Clinical Study
Researchers have found that consumption of the probiotic strain DE111® in conjunction with adequate post-workout nutrition can improve body composition and indices of athletic performance during offseason training in collegiate athletes, according to a study recently published in the Journal of Strength and Conditioning Research.
The study found that compared to the placebo, the probiotic DE111 produced statistically significantly improvements in the reduction of body fat percentage, and a strong trend indicating improved performance of the deadlift exercise. “These findings are encouraging for athletic individuals, both professional and recreational, that are looking for ways to naturally achieve maximum results from their training efforts,” said Dr. John Deaton, vice president of science and technology at Deerland Probiotics & Enzymes.
Twenty-three collegiate female athletes participated in the double-blind, randomized, placebo-controlled study. The athletes completed the same 10-week resistance training program during the offseason, which consisted of 3-4 workouts per week of upper and lower-body exercises and sport-specific training. The athletes consumed a DE111 or placebo supplement in conjunction with a recovery protein drink immediately following resistance and sport-specific training for the entire 10-week program.
DE111 is a genome sequenced and clinically tested strain of Bacillus subtilis, a probiotic spore that supports digestive and immune health. The genome sequencing confirmed the strain contained no plasmids, antibiotic resistant or deleterious genes; the human clinical studies showed the strain’s ability to control microbial populations, aid in digestion and maintain general health. DE111 has the ability to form spores that protect the microbes from harsh conditions until they enter an environment ripe for germination, such as the GI tract. Because of this spore-forming ability, DE111 remains viable under a wide temperature and pH range, making it ideal for use in supplements as well as food and beverages.
Probiotics, living microorganisms like yeasts and bacteria in our intestines, promote digestive health, support a healthy immune system, and can help reduce the unwanted effects of bloating, gas, or diarrhea. Prebiotics, on the other hand, employ the non-digestible fibers or starches commonly found in legumes, whole wheat foods, onions, cabbages, asparagus, and oatmeal to help probiotic microorganisms flourish. In addition, novel prebiotics, such as lactoferrin, almond lipids and bacteriophages are being identified. Synbiotics, supplements that combine probiotics and prebiotics in a powerful synergy, can maximize the beneficial effects of both.
Prebiotics Help Probiotics Survive and Thrive
Probiotic supplements contain live microorganisms that enhance health by improving the balance of microflora or microorganisms in the gastrointestinal tract. But to be effective, probiotics must survive the stomach’s acidic environment, as well as bile and pancreatic secretions into the small intestine. Once they survive, probiotics then compete for nutrients with harmful bacteria in the gut.
Prebiotic supplements help maintain digestive balance while supplying the required nutrition probiotics need to thrive. A prebiotic is defined as a non-digestible food ingredient that beneficially affects the host by selectively stimulating the growth and activity of a limited number of bacteria in the colon. This implies that each individual prebiotic may stimulate the growth and activity of some probiotics but not others. The key is careful selection of the appropriate prebiotic that improves the functionality of each probiotic.
Synbiotics Provide the Right Combination of Prebiotics and Probiotics
There is a right way to combine selected probiotics and prebiotics into an optimal product supplement that feeds the human biome. Many common fiber-based prebiotics have the unfortunate side effect of feeding both good and bad bacteria. In addition, they typically require massive doses to be effective – doses which won’t even fit into a single capsule – and may cause gas and digestive discomfort. An ideal synbiotic, on the other hand, should combine the correct prebiotics in the exact proportions necessary to maximize the desired beneficial health effects of specific probiotic strains by stimulating the growth and activating the metabolism of a limited number of health-promoting bacteria. In this way, synbiotic products improve the survival of live microbial supplements in the gastrointestinal tract. When the synergistic effect is optimized between prebiotics and probiotics, the beneficial effects of each are optimized.
Probiotics and Prebiotics Together Make a Dynamic Duo
Enzymes alone are good, enzymes plus probiotics are better, and enzymes, probiotics, and prebiotics together are best. Enzymes help drive the nutritional uptake of the food while the probiotics ensure a good digestive balance and flora. Deerland Probiotics & Enzymes developed the novel prebiotic, PreforPro, to further enhance the health benefits of these supplements. More than 20 studies have been performed to confirm the safety and efficacy of PreforPro in promoting the growth of a broad spectrum of probiotic species while crowding out undesirable bacteria.
Learn more about the prebiotic power of PreforPro by visiting https://www.deerland.com/preforpro/ today.