Healthy Trinity White Paper - Natren, Inc.

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Healthy Trinity White Paper

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Healthy Trinity®

Natren has developed a unique and innovative micro-enrobing delivery system with three carefully selected super strains totaling 30 billion cfu:

Natren isolates the most effective combination of naturally selected super strains of L. acidophilus and B. bifidum bacteria to optimize the health of the small and large intestines, while the L. bulgaricus super strain assists in regulating the often-neglected transient flora. Each microorganism is FDA referenced as a GRAS (Generally Recognized As Safe) substance. These bacteria are incorporated in an oil matrix carrier and encapsulated in Healthy Trinity's two-piece hard gel capsule, which helps maintain healthy intestinal flora, aids digestion and absorption. Healthy Trinity is free from:

NOs

**Natren does not use ingredients produced by biotechnology.

 

What makes an effective delivery system?

The Healthy Trinity Capsule

capsule

The Healthy Trinity capsule provides an exceptional delivery system and is an innovative technology on its own. The two-piece hard gelatin capsule is banded and sealed with gelatine; then each capsule is monitored individually, by eye, to ensure full containment of the oil matrix micro-enrobed probiotic formula.  Gelatin was chosen because of its low-moisture content and the capsule color is all natural (because of this it may vary slightly batch to batch).  We specifically designed the capsule to be dark in color to further protect the probiotic from damaging UV light. The capsules are 100% beef gelatin, and kosher certified.

The Trenev Process®

The Trenev Process is a unique protective oil matrix delivery system only available from Natren technology. We believe there is no better protection for the probiotic bacteria to survive the harsh gastric environment and to successfully reach their destination in the upper small intestine. Large numbers of bacterial cells can die due to a lack of protection from stomach acids, making potency guarantees meaningless without an independent measurement of survivability. When selecting a probiotic it is important to think about these challenges and ask questions. What does 50 or 100 billion cfu mean if the probiotic product does not reach the intestines where it is most active?

What does 50 or 100 billion cfu mean if the probiotic product does NOT reach the intestines where it is most active?

Natren's proprietary oil matrix delivery system micro-enrobes each strain of bacteria, this process arrests their growth, keeps the three strains separate and noncompetitive and ensures that beneficial Natren strains are shielded from harsh and corrosive stomach acids, providing virtually 100% survivability for over one hour in a pH as low as 1.8. This has been tested and validated by an independent third-party internationally acclaimed European institute. Natren's micro-enrobing delivery system consists of sunflower oil and vitamin E, with all oxygen and water removed by a gentle chemical-free process, creating a totally anaerobic (oxygen-free) environment.

intestines

Natren's oil matrix complex significantly improves the probiotic effect of Healthy Trinity because oil is not broken down by gastric juices; it is emulsified by bile, which is secreted by the bile duct located just above the intestines. It is important to note that Natren super strains show excellent bile tolerance, as evidenced by continuous in vitro studies conducted by Silliker Laboratories in southern California. (1) The probiotic will remain potent through the acidic stomach barrier, to flourish in the small and large intestines where they provide optimal benefit. The potency of Healthy Trinity is improved substantially by (1) ensuring we start with high-quality and well tested cells; (2) do not stress the cells by exposing them to competing bacteria and enrobe each strain individually from one another; (3) protect the probiotic cells through an exceptional, tested and proven delivery system. This technology cannot be obtained from any other manufacturer in the world. 

The Healthy Trinity Super Strains

strains

What is a super strain?

A super strain is just as it sounds; a strain that is of higher quality or superior in action to other bacterial strains. Natren super strains are of high quality, efficacy and have been verified by clinical trials, and backed by decades of safety and efficacy records. Below, we will look at each strain in Healthy Trinity in detail. 

What makes the NAS super strain unique?

The Healthy Trinity oil matrix capsules contain L. acidophilus, NAS adhesion strain, a gram-positive facultative anaerobic rod. This is an organism normally found in the major part of the small intestine beyond the duodenum.

An L. acidophilus strain that adheres to the intestinal wall, known as a "sticker" is superior to L. acidophilus strains that do notexpress this feature. It has a polysaccharide cell wall surface (similar to the Velcro® phenomenon) that facilitates better adhesion. For the host to benefit from the consumption of L. acidophilus, the strain should be able to adhere and grow in the dynamic environment of the gastrointestinal tract. Typically, calcium found in milk provides natural adhesion to the intestinal wall, however, Healthy Trinity is dairy free and adherence can be a challenge for dairy free probiotics products, which do not have natural calcium ions. (2) Natren's dairy free NAS strain maintains this adherence feature without the milk base which is one reason it is distinguished as a super strain. (3)

How does NAS super strain help?

In vitro studies have demonstrated the following characteristics of certain strains of L. acidophilus, including NAS:

 

In vitro studies have demonstrated that L. acidophilus, has distinct antimicrobial and anti fungal activity against potentially pathogenic organisms, including Clostridium difficile, Candida albicans, Escherichia coli, Pseudomonos aeruginosa, Salmonella tymphimurium, Staphylococcus aureus and Helicobacter pylori. (12)(13)(14)(15)(16)(17)(5)(28)(23)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53)

An additional in vitro study showed, L. acidophilus, NAS strain exhibited antimicrobial activity against H. pylori. (48)

The NAS super strain also has proven ability to secrete a diverse array of bacteriocins. (54) Bacteriocins are a group of peptides or proteins that have natural antimicrobial activity, thereby eliciting additional probiotic benefits. (54)

What makes the Malyoth super strain unique?

Healthy Trinity oil matrix capsules contain B. bifidum, Malyoth super strain, a gram-positive obligate anaerobic branch shaped rod. This is an organism normally found in the large intestine.

Bifidobacterium species, such as bifidum, not only need to be human host specific, but also infant or adult specific. Biovar is the classification used to denote whether a species is adult or infant specific; for example, biovar a (adult) or biovar b (baby). For optimal benefit, the appropriate biovar of bifidobacteria should be administered. The Malyoth super strain of B. bifidum — biovar a is an appropriate supplement for adults and for children who have been weaned from breast milk. This strain has been used successfully in liver detoxification studies. (55)(56)(57)

How does Malyoth super strain help you?

Bifidobacterium bifidum possesses the following positive characteristics:

Bifido declines with age

Aging lowers gastric acidity and allows more competitive microorganisms to reach the large intestine, resulting in a loss of valuable bifidobacteria. (62) The spaces left vacant on the wall of the large intestine by the lack of bifidobacteria are gradually taken over by undesirable bacteria. Noxious bacteria form substances that cause putrefaction and contribute to intestinal problems.

Healthy Trinity capsules are commonly used as a nutritional adjunct to replenish normally occurring beneficial organisms in the gastrointestinal tract. This is vital, particularly during and following antibiotics, corticosteroids (cortisone), chemotherapy, diarrhea, and chronic yeast or bacterial overgrowth. Ongoing stress also negatively alters the delicate balance of beneficial bacteria. In fact, Japanese research indicates that Bifidobacterium is the most important beneficial bacteria for human health. (63) In vitro studies have demonstrated the following effects of Bifidobacteria bifidum:

What makes the LB-51 super strain unique?

The third strain in the Healthy Trinity oil matrix capsule is L. bulgaricus, LB-51 super strain. L. bulgaricus, LB-51 is a facultative anaerobic gram-positive rod. This is an organism that can be found throughout the digestive system; it progresses through the intestines as food is digested. It may take up to two weeks to pass through the digestive tract; along the way, L. bulgaricus naturally aids digestion and helps contain unfriendly organisms. L. bulgaricus, LB-51 super strain has been studied in Bulgaria for more than 30 years by leading scientists. Its unique properties are well documented.

Lactobacillus bulgaricus has recently been renamed L. delbruekii subspecies bulgaricus.

How does LB-51 super strain help you?

In vitro studies have demonstrated benefits of certain strains of L. bulgaricus:

Why only three strains?

Probiotic bacteria do not "play nice" together.

Symbiosis is not common to bacteria. Antagonism is more common. (78) Strains that are mixed together fight for survival and may inhibit one another and decrease each other's growth, thereby decreasing health benefits. Blends of probiotics should be made so that each strain of probiotic is kept separate from one another.

That's why Natren mixes a maximum of only three organisms, and uses their own unique and scientifically tested technology to micro-enrobe each organism in a protective oil matrix delivery system to keep each strain separate and non-competitive.

World Renowned Probiotic Expert, Professor Gregor Reid agrees with Natren's long standing premise that multi-strain probiotics may not necessarily be better than products containing one, two or three strains.

Professor Reid commented that little is known about the way different species of bacteria interact because some strains inhibit the activity of others when placed together. (79) He stated that "The tendency is ‘let’s have 15 strains...let’s have 28 billion’,“you’ve got to know what they’re doing. Are they really having an impact?” (79) He questions“...what is the point of putting them in the same container if they [different strains] inhibit each another?” (79) Professor Reid is one of the leading experts in the field of probiotics. He is a Professor at the University of Western Ontario, but more impressively he has been the chairperson of the United Nations World Health Organization Expert Panel and Working Group on Probiotics.

Unstudied probiotic bacteria may have little or no value.

There is no agency checking the validity of these probiotic strains and assuring that they're of any value or worse yet, not causing any harm. For example, years ago multi-strain producers were including an organism called Enterococcus faecium in their products because it was hardy and resistant to heat and other damaging affects that normal probiotics are susceptible to.
Years later, it was discovered that Enterococcus faecium may induce antibiotic resistance in other bacteria and it was eventually removed from these probiotic products due to this potential danger. (80)
Natren has always used the core, scientifically proven safe, and effective bacterial strains such as Lactobacillus acidophilus, NAS, Bifidobacterium bifidum, Mayloth and Lactobacillus delbrueckii subspecies bulgaricus LB-51.

Not all strains provide health benefits. This is why you must rely on a reputable probiotics manufacturer to research and formulate its probiotics with the best and most beneficial bacteria available.

The Global Institute of Probiotics

 

Clinical Studies

Natren has completed several clinical trials and continues to explore future trials. Completed trials pertaining to Healthy Trinity or its individual probiotic strains are outlined below:

-Yale University School of Nursing in 2001 studied the weekly administration of L. acidophilus, NAS super strain intra-vaginal suppository, the results showed 50% reduced relative risk of an episode of vaginal candidiasis in HIV-infected women. (81)

-University of California, Davis, in a double blind, crossover clinical trial completed in 2003 found a significant reduction in yeast infections among college women who followed daily administration of L. acidophilus, NAS intra-vaginal suppository in combination with the Healthy Trinity oral capsule. (82)

-Lactobacillus bulgaricus, LB-51 super strain was included in a Proof of Concept study in 2011 showing reduced hunger between meals in people taking this probiotic. (83) Expansion into a larger clinical trial is planned.

-The University of Alberta, Edmonton in Canada completed a randomized clinical trial in 2013 that showed Healthy Trinity helped reduce the mean lesion count of women affected with acne in an otherwise healthy population. (84)

-Natren has also completed numerous in vitro studies and additional Clinical Trials relevant to other probiotics they produce.

Trusted experts in the probiotic field

The probiotic specialist recognized worldwide®

Thermally Controlled Shipping

Natren’s superior supplements consistently lead the field of probiotics with recognized pharmaceutical grade quality, in several ways:

Thorough and diligent selection of tested and naturally occurring super strains, with no artificial genetic manipulation. Natren does not use any ingredients produced by biotechnology. For example, there are many different strains of L. acidophilus, each with varying strengths and each providing different probiotic benefits. Natren’s L.acidophilus, NAS strain has been carefully selected for its numerous beneficial properties.

The number one enemy of probiotics is moisture. Plastic is not a sufficient barrier to moisture. Light and heat are also harmful to probiotics. Therefore, Natren probiotics are packaged in naturally dark capsules placed into dark glass bottles with metal caps providing the ultimate protection against moisture and heat. Natren also manufactures in a temperature controlled environment and the probiotics are stored refrigerated and always shipped in thermally controlled boxes.

Natren created an exclusive oil matrix delivery system to keep each bacterial strain separate and noncompetitive. Not only does this system maximize survival under the recommended shelf life conditions, it also protects the probiotics as they travel through the digestive system. The oil matrix protects bacteria as they travel through the stomach and is emulsified by bile in the upper GI tract where the (bile tolerant) bacteria are released to begin colonization and growth. 

Each strain has been tested for bile tolerance by Silliker Laboratories. The laboratories’ Technical Director of Microbiology, Western Region, has stated that no further bile tolerance tests need to be run, as Natren strains have “demonstrated (bile tolerance) repeatedly on sequential lots for a period exceeding two years, both on MRS and Rogosa agar containing 0.1 5% oxgall.” (1) Guaranteed Potency.

Natren takes pride in its accomplishments over the last 30 years to identify the most effective probiotic species and strains. The company is able to offer an unconditional guarantee of potency for each listed strain through the printed expiration date on its probiotic product labels, NOT the date of manufacture as stated on other probiotic brand labels.

For adults and children over 8 years of age. Take 1 or more capsules daily. Healthy Trinity oil matrix capsules are formulated to be taken with meals to enhance digestion but may be taken at any time.
Note: Healthy Trinity capsule size (00) may not be suitable for young children, although contents of capsule are nontoxic and safe for children. Those who have difficulty swallowing capsules, such as young children, may find Natren's powdered probiotic formulas more suitable.

Storage


Potency guarantee

NT Cameo

Each capsule is guaranteed to supply a minimum of:

References
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3. Zottola, Edmund A. Examination of 17 strains of Lactobacillus acidophilus by Transmission Electron Microscopy for the presence of exopolysaccharide material . Research Report submitted to Quali-Tech, Inc. 1989.
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15. Adhering heat-killed human Lactobacillus acidophilus, strain LB, inhibits the process of pathogenicity of diarrhoeagenic bacteria in cultured human intestinal cells. Coconnier, Marie-Helene, Marie-Francoise Bernet, Gilles Chauviere, and Alain L. Servin. s.l. : Journal of diarrhoeal diseases research, 1993, Journal of diarrhoeal diseases research , Vol. 11, pp. 235-235.
16. Inhibition of adhesion of enteroinvasive pathogens to human intestinal Caco-2 cells by Lactobacillus acidophilus strain LB decreases bacterial invasion. Coconnier, Marie-Hélène, Marie-Françoise Bernet, Sophie Kernéis, Gilles Chauvière, Jacky Fourniat, and Alain L. Servin. 3, s.l. : FEMS Microbiology Letters, 1993, FEMS Microbiology Letters, Vol. 110, pp. 299-305.
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18. Inhibition of initial adhesion of uropathogenic Enterococcus faecalis by biosurfactants from Lactobacillus isolates. Velraeds, M. M., H. C. Van der Mei, Gregor Reid, and Henk J. Busscher. 6, s.l. : Applied and Environmental Microbiology, 1996, Applied and Environmental Microbiology , Vol. 62, pp. 1958-1963.
19. Inhibition of initial adhesion of uropathogenic Enterococcus faecalis to solid substrata by an adsorbed biosurfactant layer from Lactobacillus acidophilus. Velraeds, Martine, Henny C. Van Der Mei, Gregor Reid, and Henk J. Busscher. 5, s.l. : Urology, 1997, Urology, Vol. 49, pp. 790-794.
20. Effect of diet and Lactobacillus acidophilus supplements on human fecal bacterial enzymes. Goldin, Barry R., Linda Swenson, Johanna Dwyer, Margaret Sexton, and Sherwood L. Gorbach. 2, s.l. : Journal of the National Cancer Institute, 1980, Journal of the National Cancer Institute, Vol. 64, pp. 255-261.
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25. Systemic augmentation of the immune response in mice by feeding fermented milks with Lactobacillus casei and Lactobacillus acidophilus. Perdigon, Gabriela, M. E. De Macias, S. Alvarez, G. Oliver, and A. Pesce de Ruiz Holgado. 1, s.l. : Immunology, 1988, Immunology, Vol. 63.
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48. Antimicrobial effect of Lactobacillus acidophilus and Lactobacillus delbrueckii subsp. bulgaricus against Heliobacter pylori in vitro. Rasic, Jeremija, et al. 4, s.l. : Arch. Gastroenterohepatol, 1995, Arch. Gastroenterohepatol, Vol. 14, pp. 158-160.
49. Rasic, Jeremija. Laboratory Studies. 1989-1993.
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51. Natural antibiotic activity of Lactobacillus acidophilus and bulgaricus. III. Production and partial purification of bulgarican from Lactobacillus bulgaricus. Reddy, G. V., K. M. Shahani, B. A. Friend, and R. C. Chandan. s.l. : Cultured Dairy Products Journal, 1983, Cultured Dairy Products Journal , pp. 15-19.
52. Natural antibiotic activity of Lactobacillus acidophilus and Bulgaricus. II. Isolation of acidophilin from Lactobacillus acidophilus [Milk]. Shahani, K. M., J. R. Vakil, and A. Kilara. 2, s.l. : Cultured Dairy Products Journal, 1977, Cultured Dairy Products Journal, Vol. 12, pp. 8-11.
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