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September 16, 2008, Product Training call script:
Renew with Specialized Nutrition

Hello, and good evening, Everyone. This is Charlotte Carreira, your VP of Marketing & Sales, and I am so pleased that you have joined us for our monthly Simplexity Health product training call with Russell Mariani. Russell is a health educator and nutrition counselor in South Hadley, Massachusetts, where he directs the Center for Functional Nutrition. He is the author of the book Healing Digestive Illness and of Simplexity Health's comprehensive online product and nutrition educational program called The Journey to Better Nutrition. Russell has been an active IBA with Simplexity Health since 1987 and currently serves as a member of our training team. He is passionate about teaching others how to become more proactive in their own self-care, and continues to help us all experience positive and consistent results with our Simplexity Health products.

Also, we have a very special guest, Simplexity Health's Executive VP Jerry Anderson who, as a biochemist, is the most qualified to discuss the science behind the products we will be featuring.

I would like to start the evening with the Simplexity Health vision statement.

Our Vision

We choose to help build a sustainable world of prosperity and abundant health, where all people will one day have ready access to the life-enhancing benefits of natural, wholefood nutrition and the opportunity to realize personal success.

Just as I like to remind everyone (myself included) about our remarkable Vision, I also like to remind us all about the core thinking that guides the way we teach others about our products: Our products stay true to a simple philosophy:

The human body is a marvelously designed living organism with the ability to grow, regulate, repair, and defend itself when given natural, premium, full-spectrum nutrition.

Our remarkable, high-performance products support this simple philosophy, which can therefore have a profound effect on the quality of our health. Each Simplexity Health product is designed to effectively address the body's needs in one or more of the four basic nutritional building block areas:

  • First, to Nourish with Superfood Nutrition, which we discussed on our product training call in June
  • Second, to Energize with Digestive Nutrition, discussed in July
  • Third, to Protect with Antioxidant Nutrition, discussed in August
  • Fourth, Renew with Specialized Nutrition, which we will discuss tonight

I would also like to remind everyone that these calls are recorded and then posted to our website. Also, per the request of many of you in the field, the actual text of these four calls are posted on the website as well.

When these four nutritional building blocks are met daily and consistently, the body receives the full spectrum of raw nutrients to restore and maintain normal cellular functioning. Normal cellular functioning results in the experience of overall health and well-being, including but not limited to energy, vitality, flexibility, stamina, creativity, optimism, and the desire to make a contribution to the lives of others!

Teaching people how to achieve a level of overall health and well-being is what we are all about here at Simplexity Health, as we have been for the last 25 years, will be for at least the next 25!

Okay, tonight's call topic is Renew with Specialized Nutrition, which is the fourth of our four building blocks that make up the foundation of the Simplexity Health Functional Nutrition Model. I would like to bring Russell Mariani into our discussion of this important topic by asking: Why do we have this fourth building block area? And how is it different from the other three?

(Russell)
Hi Charlotte, and hello to everyone out there in our virtual hotel room. Great questions to start with, so let's get right to the answers.

Functional Nutrition is based on addressing all of the physiological or nutritional needs of the body--at the cellular level. When cells receive the full spectrum of the micronutrients they need, they correct their own imbalances…they correct their own dysfunctions…they put themselves back on the path of normal functioning, which is the path that leads to optimum health and well-being.

Under ideal environmental, dietary, and lifestyle circumstances, most people would probably be able to restore normal functioning to all the cells, organs, and systems of their body by just utilizing the products from the first three nutritional building block areas, together with other complementary choices in the rest of their diet and lifestyle. But the fact is that the combination of widespread pollution in our environment, the amount of processed and chemically altered foods in our modern diet, and unprecedented stresses and strains of hectic, fast-paced, sleep-deprived modern lifestyles, calls for some kind of "specialized nutrition" that goes beyond what used to be called or could be called the traditional building block areas of superfoods, antioxidants, digestive enzymes, and probiotics.

What makes the products in this fourth building block area different from the other three is that they are targeting very specific functions or targeting very specialized cells within those specific functions. To illustrate what I am talking about here, let's go directly to an explanation of the three major product offerings in this fourth building block area. When we talk about this fourth building block area we are talking primarily about three products: StemPlex®, ImmuSun®, and OsteoSun™.

StemPlex is a unique product consisting of certain nutrients that have been scientifically proven in vitro to increase the growth of adult stem cells inside the human body.* Adult stem cells have the ability to transform or change into whatever cell the body needs them to become. In this way adult stem cells represent the body's innate ability to heal itself. More about StemPlex in a few minutes.

ImmuSun contains the active ingredient WGP™ beta glucan, a patented form of the complex carbohydrate beta glucan, which is found in the cell wall of baker's yeast. Scientists first discovered the immune-boosting properties of beta glucan in the 1960's. Since then, many studies have documented its potential as an immune system enabler and enhancer. Healthy, highly activated and aggressive macrophages are essential to a healthy human immune system…and a healthy immune system is the very best way to guarantee overall health and well-being.

OsteoSun is an all-natural, non-calcium dietary supplement that has been scientifically proven to maintain existing bone health and, when necessary, stimulate new bone growth.* OsteoSun contains a very special proprietary form of red yeast rice, a natural food product that has been used in Oriental cuisine for centuries for a variety of health benefits. Using a patented technology, many different strains of red yeast rice were tested, but only the strain that is the most bone-active was chosen for use in OsteoSun. Unlike other products on the market, OsteoSun enhances the body's natural ability to restore bone mass, and is scientifically proven in vitro and in an animal model to build new bone.* OsteoSun also contains Super Blue Green® Omega Sun® algae, which, in addition to all its other benefits, aids in the assimilation of red yeast rice and other helpful nutrients like minerals and trace minerals that our bones also need in order to remain normal and healthy, strong and resilient.*

What I would like to do now is to introduce and welcome to our conversation Jerry Anderson, Simplexity Health's Executive Vice President. Jerry has been with us for over ten years now and has served the Home Team and all of us out here in the Field in a variety of important capacities. One of those capacities was as manager of Research and Development, where he was instrumental in directing in-house research as well as discovering and organizing research and scientific studies on our existing products as well as in creating protocols for the development of new products. In the last few years Jerry has been a pivotal player in the discovery and development of the three products we have been talking about tonight: StemPlex, ImmuSun, and OsteoSun, so we thought it would be a great idea to bring him on the call and ask him to share his enthusiasm and expertise about these products.

(Jerry)
Thank you, Russell and Charlotte. It's a pleasure to be on all the call. Thanks to those of you joining us tonight. A bit about myself…

I have been with the company for 10 years. I started working in the research lab testing and developing products. I moved on to overseeing the operations and I now enjoy working with the field and with Marketing and Sales.

(Russell)
Before we ask you specific questions related to the science behind our three featured products, Charlotte and I wanted to ask you to clarify a few general questions we get a lot from the customers and distributors in the field related to the whole issue of scientific studies. The first question is this: Why are scientific studies important? And I guess an obvious related question is "Why are scientific studies related to our specific products important?"

(Jerry)
The nutritional supplement industry's reputation can be, and has been, damaged by companies and products that do not perform as advertised. As a member of the nutritional supplement community, we want to do our best to maintain the integrity of the products and the industry. Research and science are key in determining the effectiveness of the supplement. Anecdotal evidence (undocumented reports) is great and can be used in determining the direction of product research. But scientific studies provide proof?or at least evidence?that the product performs as described. With a background in science, I appreciate the value of research. I believe in science-based products. People buy our products because they work. People feel the effects and the benefits of our products. All of our products have at least some research to back them up.

Many of you are familiar with some of the research that has been done on SBGA (i.e., immune support, antioxidant support, adult stem cell support, bioregulatory effects). Digestive enzymes and probiotics are also supported by the scientific literature. Antioxidants, as well. The same with the other products. For example, the nutritional properties and benefits of the sprouts and greens in Go Green are well documented. If someone is going to spend money on our products, we want to do our best to ensure that the product is beneficial.

(Charlotte)
Jerry, the next question is this: When Russell gave us the brief explanations of StemPlex, OsteoSun, and ImmuSun earlier, he used the terms "in vitro" and "in vivo." Could you explain what these terms mean, and could you also comment about whether one is more important than the other, and why?

(Jerry)
In vitro is Latin for "in the glass." In vitro tests are conducted in test tubes or Petri dishes. They do not involve testing on animals or humans. In vitro tests are a good place to begin a research project, as they are relatively inexpensive compared to other types of research, and they can point to the direction of further research. In vivo is Latin for "in the living organism"; technically, it can mean in an animal or in a human, but it generally means research done with animals. In vivo research usually follows in vitro research.

(Russell)
Before we dive in and get more specifics about StemPlex, could you tell us, Jerry, what is the basic difference between embryonic stem cells and adult stem cells? And what is the controversy about?

(Jerry)
There is a lot of interest and potential in stem cell research for treatments. Embryonic stem cell research is controversial. No debate exits with adult stem cells because adult stem cells are naturally occurring in everyone's body. StemPlex works on adult stem cells.

(Russell)
Now let's spend a little time on the science behind each of these three products. First, StemPlex. Jerry, tell us how you, that is Simplexity Health, first came across the research that eventually led to the product we now call StemPlex. Give us a brief history of the evolution of this amazing product.

(Jerry)
We learned from the majority shareholder of Simplexity Health about scientists in Florida who were developing a stem cell nutritional product. This was one of the first projects President and CEO Bob Underwood and I worked on together. We visited the researchers in Florida, and were impressed with them and their science, so we developed StemPlex. Paula Bickford has a Ph.D. in pharmacology. She is currently a Professor in the Department of Neurosurgery and the Center of Excellence for Aging and Brain Repair at the University of South Florida. And she is a Senior Research Career Scientist at the James A. Haley Veterans Affairs Hospital in Tampa. She is now working on nutritional interventions that she and her colleagues have shown will reverse age-related declines in neurophysiology and behavior. Her most recent work has focused on the effects of nutrients on adult stem cells.

Dr. Bickford has a team of scientist she works with. We are pleased to be associated with this group of well-respected researchers. The ingredients (and amounts) were selected based on the research by Dr. Bickford's group. Many different substances were tested for their effect on the growth of adult stem cells. The all-natural ingredients in StemPlex are green tea extract, wild blueberries, carnosine, wild blueberry extract, vitamin D, and our organic microalgae.

(Charlotte)
Let's talk about the two research studies that have been completed so far on the base formula of StemPlex. And by the way, for everyone listening, much of this information is available in your IBA training manual called Getting Started with Simplexity Health, which is included in your IBA kit. So, first tell us about the study titled Nutraceuticals Promote Proliferation of Human Stem Cells.

(Jerry)
First, we need to answer the question: What are stem cells? All stem cells are capable of dividing and renewing themselves for long periods of time, and they can give rise to specialized cells. Stem cells have the remarkable potential to develop into many different cell types in the body. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, a skin cell, etc. When released, new stem cells migrate to areas of the body where they are needed most. Serving as a repair system for the body, stem cells can theoretically divide without limit to replenish other cells as long as a person or animal is alive.

This was the first study, and it was done in vitro. The purpose of this study was to investigate the properties of various natural compounds for their ability to stimulate the proliferation (or growth) of human adult stem cells. Three types of stem cells were studied: bone marrow cells, CD34 cells, and CD133 cells. The results:

  • BMC proliferation increased from 44% to 70% when compared to the control.
  • CD34 proliferation increased from 48% to 68%.
  • CD133 proliferation increased from 21% to 43%, which is about double that of the control.

Remember that we are comparing the formula to a substance known to support the growth of stem cells. So the effect is remarkable.

While conducting this research, something interesting was discovered that surprised the scientists. The growth was shown to be synergistic; that is, the sum of the individual effects for each ingredient was less than the combined effect of the formula. This study demonstrated-for the first time-that certain natural compounds can promote the growth of hematopoietic stem cells in vitro to support your body's natural renewal system.

(Russell)
The second study was titled Oxidative Stress of Neural, Hematopoeitic, and Stem Cells: Protection by Natural Compounds. What can you tell us about this study, Jerry?

(Jerry)
The second study was completed by the same group of scientists. They took the research to the next level-in vivo (or in a living organism); in this case, an animal model. Additionally, this study also has an in vitro section. Because recent studies indicate that oxidative stress limits the capacity of stem cell self-renewal, the base formula of StemPlex was investigated for its ability to reduce the effects of oxidative stress on the survival of cells in vitro and in vivo.

During natural aging, adult stem cells are known to have a reduced restorative capacity and are more vulnerable to oxidative stress, resulting in a reduced ability to heal themselves. However, a rapidly growing body of literature now indicates that certain substances could have important roles in the proliferation and maintenance of a continuous replacement of stem cells required for healthy self-renewal of mature cells in blood, brain, and other tissues.

For the in vitro study, samples of two types of central nervous system cells (microglial & neurons) were treated with the base formula of StemPlex, and then the cells were exposed to an oxidizer. The results: In vitro, the StemPlex base formula increased the survival of neural cells from 10% to 60%, and microglial cell survival increased from 25% to 65% when compared to the control. When these cells were exposed to an oxidizer, few cells survived. But when treated with the StemPlex base formula, 60% to 65% of the cells survived.

For the in vivo study, mice were fed either a normal diet or a normal diet plus the StemPlex base formula. After two weeks of this feeding regime, bone marrow cells were then exposed to an oxidizer to determine the survival rate. The results: In vivo, in the samples treated with the StemPlex base formula, survival increased from 15% to 55%.

An interesting point to note is that the individual ingredients of StemPlex had little effect. It was the combination of ingredients that had a large effect. Again, a synergistic effect was seen. This study demonstrated-for the first time-that this proprietary natural product formulation reduces oxidative stress. Oxidative stress is a well-known physiologic process associated with aging and one that reduces the capacity for stem cell self-renewal. A major strength of this study was that the in vivo findings suggest that the base StemPlex formula should have the capacity to increase the viability of stem cell populations and reduce oxidative stress in humans when given orally as a dietary supplement.*

A third research paper, published this year, demonstrated proliferation and homing (mobilization) of stem cells to a challenge site in an animal model. It shows an increase in proliferation of the neural stem cells in the area where they grow (this is similar to bone marrow where the hematopoietic stem cells grow). The study shows that there are more stem cells in the area of the challenge, demonstrating the mobility from the stem cell source area to the area of the challenge. Thus, this paper shows both proliferation in the niche and mobilization to the site of the challenge.

This is not simply a nutritive and antioxidant product. Without getting into the details, these studies have demonstrated that the product has a biomodulating effect. This suggests that the formula is producing changes at the cellular level that increase the viability, proliferation, and mobility of these cells.

For a fourth study, we began testing our microalgae soon after forming our relationship with Dr Bickford. The research has shown that the addition of our microalgae to the formula boosts the effectiveness. The manuscript of this research is being submitted for publication this week.

I would like to point out that research on StemPlex is ongoing. A clinical (human) study is in the planning stage. We hope to get it started soon.

(Charlotte)
The key thing for our listeners to know is that the unique formulation of ingredients in StemPlex has a synergistic effect.

Now let's talk about ImmuSun. Jerry, the active ingredient in ImmuSun is WGP™ Beta Glucan, which is derived from baker's yeast. Is this the same kind of baker's yeast I can buy in the supermarket and make homemade bread with?

(Jerry)
ImmuSun is a dietary supplement that fortifies the body's immune system.* Yes, the same baker's yeast you can buy at the grocery store and use to make bread is the source of the active ingredient in ImmuSun. What is different is that the beta glucan in ImmuSun is a concentrated specific form of a carbohydrate from the cell wall of baker's yeast. So baker's yeast will not have the same effect on the immune system as ImmuSun.

(Charlotte)
Jerry, tell us the history of this product. How did Simplexity Health discover it, and why did we decide to include it?

(Jerry)
We learned about this special ingredient-Beta Glucan-from connections in the industry. We checked out the company and the research and thought the product would be a good fit for the company, mostly because the product has a lot of research to back it up. There are other products on the market, but none with the body of research that back up the effectiveness. It is a proprietary, specialized process (patented) to create the physical structure and biological activity of the active ingredient in ImmuSun-WGP 1/3-1/6 beta glucan.

(Charlotte)
Jerry, what is the most important thing you have learned about ImmuSun over the past few years. And how extensive is the research on the particular kind of beta glucan that we use in ImmuSun?

(Jerry)
First, I have found ImmuSun to be effective for me. Our bodies work around the clock to protect us from harmful invaders. But sometimes our defenses can't keep pace with the growing number of threats we're exposed to each day. The active ingredient in ImmuSun supports the production and activity of macrophages, a type of white blood cell that is the immune system's first line of defense*. Macrophages help maintain the body's overall health.

The immune-enhancing properties of yeast cell walls were reported in 1939. But it wasn't until the 1960s that researchers identified beta glucan as the immune-stimulating component. Since then, scientists at some of the world's pre-eminent universities and research institutions have conducted hundreds of beta glucan studies. One of the most exciting developments in the history of yeast beta glucan is a substantial body of data establishing the efficacy of orally consumed yeast beta glucan. This research confirms that beta glucan produces multiple broad-scale effects that strengthen the vitality of the immune system.*

ImmuSun engages the body's natural defenses to protect it against a wide range of challenges.* The ingredients have a clinically proven mechanism of action that activates innate immune cells.

A summary of some of the product's effects:

  • Increases antimicrobial activity. In clinical studies, after 10 days beta glucan had increased the percentage of immune cells able to eradicate one particle from 64% to 83%. And the number of active cells increased from 37% to more than 50%.

  • Increases immune cell activity. A placebo-controlled, double-blind clinical study conducted with 62 subjects assessed the impact of beta glucan on immune markers. Generally, the immune system responds to challenges with an increase in Natural Killer (NK) cells and T cells as primary defense mechanisms. Participants receiving beta glucan had more NK cells and T cells than participants in the control group.

  • Enhances immune cell migration to site of challenge. Neutrophils, the most abundant type of innate immune cell in the body, are among the first cells of the body to respond to a challenge. Priming neutrophils with beta glucan increases their ability to sense complement fragments emanating from the site of a challenge. A more rapid immune response results in a stronger immune system.

Regarding product safety, human and animal studies have demonstrated that the product safely enhances and supports healthy immune system function without adverse effects.* The human body has developed various mechanisms for identifying and destroying foreign challenges. The research shows that ImmuSun works to unlock these mechanisms and boost natural defenses.*

(Russell)
Let's turn our attention to our third Specialized Nutrition Product, OsteoSun. Jerry, first of all, how important is it for us as a company to have a product like OsteoSun available to our customers?

(Jerry)
Maintaining bone health is very important, especially as one ages. Incidences of poor bone health have been increasing dramatically over the past twenty years or so. If the normal integrity of the bone structures is not maintained, it can lead to all kinds of other problems especially among the elderly.

(Russell)
Jerry, tell us the story of how we came to discover OsteoSun, and a little bit about the science behind this important product. Who came to us with the product and how did it evolved?

(Jerry)
We heard about the active ingredient in OsteoSun from connections in the industry. And like ImmuSun, we researched the company and the product and decided it was a good fit for Simplexity Health.

OsteoSun is a patented, all-natural dietary supplement. OsteoSun's bone-active ingredient is a proprietary strain of red yeast rice-a natural food product that has been used in eastern Asian cuisine for thousands of years. Studies on the health benefits of red yeast rice showed that a specific strain promotes bone health-specifically, to stimulate bone formation. Red yeast rice (RYR) is rice that has been fermented by a form of red yeast (monascus purpureus). Among other uses, red yeast rice has been used Orientals for centuries as a food colorant and spice-for example, to flavor the famous Peking duck recipe. It has also been used in many traditional Chinese medicine applications.

It has been reported that certain strains of RYR produce sufficient levels of natural bone-building substances. Because of the known bone anabolic (cell-building) effect of these natural substances, it was hypothesized that RYR may be capable of stimulating bone formation.* Several different strains of RYR were examined and were found to contain high levels of natural bone-enhancing substances. These strains were shown to produce strong bone anabolic effects both in vitro and in vivo, indicating a potential application of RYR as a dietary supplement for bone health. One strain of red yeast rice-the one used in OsteoSun-stood out among the others. The results of the study: When given orally in laboratory experiments, the strain of RYR in OsteoSun was shown to increase bone mineral density significantly-by 47%- over the control ("bone mineral density" describes the density of bone).*

By identifying and isolating the most beneficial strain, the team of OsteoSun scientists developed a pure, active, effective, all-natural product for bone health.*

(Charlotte)
Thanks, Jerry and Russell. This has been a very interesting and helpful call on the fourth nutritional building block area: Renew with Specialized Nutrition.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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