Patent Application
20140170177
The invention relates to a food compound having high immunological value, based on the mixture of four protein sources (i. biotechnologically enhanced bovine colostrum; ii. egg albumin; iii. soy protein isolate; and, iv. whey protein concentrate).
Within the spectrum of currently available food supplements there are products that are from different brands and origins, having various qualitative characteristics such as immunostimulatory capacity, high bioavailability (chemical score) and digestibility, but a blend of said characteristics cannot be found in any of them.
Examples:
A search on technological information was conducted based on the elements “soya/leche/huevo/suero” and “soy/milk/egg/whey”, resulting in 14 patent applications, obtained from the following information sources:
The results of said search can be found at the end of this specification as Table 1. In that sense, it can be concluded that the search that was conducted did not find any document similar to a “Food supplement having high immunological value, based on a protein matrix”.
The following products based on a single source of proteins, based on any combination thereof or based on a source of proteins combined with bovine colostrum were also found on the market. None of them have the single combination of Bioprotein+ or a protein base with a biological value of 100%:
a) 4Life (Tri-Factor Formula): Capsules and beverages providing transfer factors as support for the Immune system.
b) 4Life (Transfer Factor E-XF): Capsules containing bovine colostrum transfer factors combined with egg yolk protein.
c) 4Life (Nanofactor Extract): Capsules containing bovine colostrum nanofactor extract.
d) Herbalife (Formula 1): Nutritional shake containing soy protein isolate, vitamins and minerals.
e) Herbalife (Formula 3): Protein supplement based on soy protein isolate.
f) Omnilife (Super Mix): Nutritional shake based on whey protein, soy protein, calcium caseinate, vitamins and minerals.
g) Naturavit: Capsules containing bovine colostrum with immune system enhancing properties.
h) Nature's Sunshine Products (Synerprotein): Protein supplement containing soy protein, essential amino acids, vitamins, minerals and fiber.
i) Nature's Sunshine Products (Colostrum Plus): Capsules containing a combination of colostrum, inositol and herbal elements to nourish and support the immune system.
j) Lab. Mead Johnson (Sustagen): Nutritional complement containing milk proteins (whole milk powder), vitamins and minerals.
k) 80/40 (Hyper Immune Colostrum): Capsules containing bovine colostrum with 40% immunoglobulin G, immune stimulant with a low casein and lactose content.
l) Tegor Sport (Tri-Matrix): Slowly assimilated combination of whey proteins, egg protein and milk protein (caseinate).
m) Aminostar: Powder supplement containing whey protein, casein and egg protein complemented with essential amino acids, vitamins and minerals for assimilation during nighttime sleep.
n) ProWinner: Powder supplement containing soy protein concentrate complemented with hormonal stimulants (soy isoflavones), with a chemical score of 61%.
o) Intact: Colostrum powder with a high protein profile.
p) Mervick: Powder supplement containing a combination of whey protein and egg protein, for athletes.
q) Pulver (Gainer, Ovoalbumin Plus): Powder supplement containing a combination of egg protein and whey protein, a muscle mass generator.
r) Hardcore: Powder supplement containing a combination of milk protein (caseinate), whey protein, hydrolyzed whey protein collagen, decaffeinated coffee, vitamins and minerals. To strengthen and repair joints for athletes and for favoring growth and weight gain.
When analyzing the currently available food supplements in the preceding section, a group of them (“colostrum”, “transfer factors”) that on one hand aims to improve the innate resistance and immunity of healthy people, and on the other hand to help them, fight against certain diseases, is identified. Other compounds however aim to provide the organism with quickly assimilated proteins to improve nutrition quality, induce growth and even suitable muscle development in anyone that practices a sport.
The premise for developing an alternative formula is based on the obvious void existing up until now. In reference to immunity, is important to take into account that simply stimulating immune system using different biological agents is insufficient; this stimulation must further be suitably supported by the nutritional status of individual, which an important factor in immune defenses. This is corroborated by the simple fact that the main molecules involved in immune defense (immunoglobulins) are proteins. Therefore, it would be rather useless to stimulate immunity in convalescent people and in people weakened by disease or in chronically malnourished people because the responsiveness of their immune system is weakened.
In the event of this panorama, the compound called “Bioprotein+” is intended for noticeably improving a consumer's immunity, whether in a healthy person or a person with a disease, because it provides immunoglobulins and transfer factors, which are both immune stimulants, comprised in a bionutritional protein compound carrier that provides nutritional support for the suitable immune system response.
Bioprotein+ is the result of the combination of biotechnologically enhanced bovine colostrum (with an immunoglobulin concentration five times greater than that of human breast milk and transfer factors), with a protein food having maximum digestibility obtained from three different sources: egg albumin, soy protein isolate and whey protein concentrate.
The steps of the Bioprotein+ production process are described below:
Objective: To receive consumables, packaging material complying with PROLIFE BIOTECH SAC's quality requirements.
Activities:
1. Receiving National Consumables: Soy protein isolate, egg albumin powder from temporary warehouse
2. Receiving Imported Consumables: Whey protein isolate, bovine colostrum protein.
3. Checking against purchase order.
4. Quality Control inspection and sampling.
5. Sent to warehouse destination.
Objective: To suitably store the consumables that are acquired and those which are temporarily delivered to production such that they do not lose their organoleptic, physicochemical and microbiological characteristics and such that they do not deteriorate.
Objective: To suitably store the additives and packaging material that are acquired such that they maintain their organoleptic, physicochemical and/or microbiological characteristics and such that they do not deteriorate.
Objective: The consumables comprised in each batch are weighed in this step.
Activities:
1. Receiving the consumables of the preceding step.
2. Weighing the consumables (fractions) according to the formula. (See Table 2 at the end of this specification)
3. The weighed fractions and sacks are sent to the mixing area, respecting the batch.
4. Excess consumables are returned to the warehouse foreman at the end of the shift.
Objective: Mixing consists of homogenizing all the ingredients according to the formulation. This operation is performed while maintaining an order for the addition of the ingredients.
Activities:
1. Emptying the consumables into the area feed hopper connected to the surge bin of the mixer through a screw.
2. The hopper discharge gate opened to fill the mixer.
3. After the mixing time, the machine is unloaded using a scow with discharge control.
4. The feed hopper, surge bin and mixer are all made of stainless steel.
Objective: Introduce the bulk mixture into sacks all having the same weight.
Activities:
1. The mixer content is unloaded into duly coded
Kraft paper bags with a polyethylene interior.
2. Each sack is weighed, then the seal is placed and the bag is sewn shut
3. The product is removed for temporary storage.
Objective: To deliver the finished bulk product to the temporary warehouse for later use
Activities:
1. Placing loaded pallets in the temporary warehouse
2. Identifying each pallet
To better understand the process that is performed, the corresponding flow chart is attached at the end of the present specification.
To achieve the highest chemical score and the highest bioavailability (100%), a mathematical model has been used for the combination of the three protein sources. This model, called “linear programming”, allowed performing simulations of the combination of different proportions of the protein compounds involved according to their amino acid input (it must be borne in mind that the critical factor for a bioavailability exceeding 99.99% is the limiting amino acid or amino acid having the lowest concentration, which must be complemented by the other sources), until determining the exact proportions that allow perfect amino acid complementation between them.
As a result of applying the “linear programming” model, a water-soluble bionutritional protein compound was obtained consisting of (% by weight)
a. Up to 6.17% of soy protein isolate;
b. Up to 76.29% of egg albumin;
c. Between 17.04% of whey protein concentrate; and
d. 0.5% of biotechnologically enhanced bovine colostrum protein concentrate.
CHEMICAL SCORE CERTIFICATE NO. 0607-2008 issued for Bioprotein+ by the Sociedad de Asesoramiento Técnico SAC, attached at the end of the present specification is provided as proof of the optimal amino acid complementation. Said certificate shows that the limiting amino acid is “lysine” with a value above 100%, concluding that “BIOPROTEIN exceeds the minimum specification of 99.99% of the Chemical Score”.
Another important factor of Bioprotein+ is its presentation as a very tasty shake because the compounds presented in dosage forms (capsules, tablets) are generally the object of misgivings and rejection by average consumers. In contrast, a tasty shake can generate a healthy consumption habit with the aforementioned health benefits.
Colostrum is the first substance that is secreted by the mammary glands of any mammal, including humans, after giving birth. This process has a very short duration (24 to 96 hours postpartum).
Scientific research conducted in the 1990s has demonstrated that the combination of immune factors and growth factors of bovine colostrum is virtually identical to that of human colostrum, and that bovine colostrum is not “species-specific”,i.e., it works effectively in humans as well as in other mammals.
Recent studies have also demonstrated that after going through puberty, the human body gradually produces fewer immune and growth factors, which are important for preventing diseases and for healing damaged tissues in the body. With the loss of these vital components, humans age until they eventually die. Colostrum is the only natural source of these vital components.
Bioprotein+ is an important source of the mentioned immune factors complemented with a protein input as nutritional support, which assures action in the human body.
The immune system is man's best defense against diseases. A disease generally indicates that the immune system has been weakened and failed. This may be due to a poor diet, pollution, chemicals, stress, exposure to electromagnetic radiations, and many other factors that humans must face daily.
Transfer factors are small peptides made up of 40 amino acids which store the entire experience of the immune system. These amino acids work the same way as the twenty-six letters in the alphabet. When they come into contact with a germ, the store the characteristics of that germ in particular, by changing the amino acid sequence.
Transfer factors are the “brains” of the immune system. They are vital for defense against invading diseases and germs. In other words, transfer factors store relevant information for humans in relation to viruses, bacteria, fungi and parasites that have attacked them in the past.
This information is then transferred to certain cells of the immune system, which will defend it against the attack of said viruses, bacteria, fungi and parasites.
Transfer factors also mobilize the so-called natural killer cells and direct them against cancerous cells. Furthermore, certain transfer factor components modulate the immune system to prevent it from attacking the body itself and causing autoimmune diseases such as rheumatoid arthritis, lupus and other illnesses.
Proteins make up about 75% of solids in the body, and they can be structural proteins, enzymes, hormones, oxygen carrier proteins, muscle contraction proteins and others that carry out specific functions inside and outside cells (see
In turn, twenty amino acids participate in the protein synthesis in living organisms. Nine of the twenty amino acids are essential amino acids and must be included in the diet; two are semi-essential amino acids (especially during childhood; in adulthood they are relevant in stress and disease) and another nine are non-essential amino acids.
These twenty amino acids are the following:
Amino acids come from digestion, where they are released from ingested proteins. Free amino acids are then absorbed by means of an active process. Animal proteins have a digestibility of about 100%, and plant proteins have a digestibility of about 70 to 80%.
The biological value is determined by:
This is important because the quality of a food protein depends on its essential amino acid content. In that regard, the FAO has indicated that a protein is biologically complete when it contains all the essential amino acids in an amount equal to or greater than the amount established for each amino acid in a standard or reference protein.
Proteins having one or more limiting amino acids, i.e., they are at a smaller proportion than the proportion established in the standard or reference protein, are considered biologically incomplete because they are not used in their entirety. The ratio of the limiting amino acid that is in the smallest proportion with respect to the same amino acid in the reference protein is called the amino acid score (AAS).
Foods of a vegetable origin such as legumes and grains make up a significant percentage of proteins in the diet, but they both have limiting amino acids reducing the efficiency of their use and they must be complemented with others to improve their quality. This can be done by adding small amounts of animal protein to them or by combining them with one another given that legumes are poor in sulfur-containing amino acids (methionine+cystine) and grains such as wheat, rice and corn, are poor in lysine (corn is also poor in tryptophan and rice is poor in threonine). Since the limiting amino acids of legumes and grains are different, a mixture of both will allow improving the amino acid score and thereby the biological quality of the protein of the mixture, a process which is called amino acid complementation.
The FAO and WHO have stressed the importance of measuring the quality of proteins n the diet (amino acids score—AAS—, digestibility) and the importance of consuming biologically complete proteins because they are factors related to diet quality and should be taken into consideration when designing a diet with a certain amount of proteins for the population (1,2). When these factors are suitably handled in the dally diet, they must assure for the consumer 100% labile body protein restoration and thus allow 100% body cell regeneration.
In the case of not having experimental data concerning digestibility of the protein in the diet or of the protein sources that make it up, it is advisable to use a digestibility value of 85% for those diets consisting mainly of plant foods and of 95% for those which are made up of a high percentage of refined grains and foods from an animal origin. However, in the first case there is a 15% deficiency and in the second case a 5% deficiency, and this gap causes greater body cell deterioration.
1.Supply of transfer factors and immunoglobulins in the daily diet. Human beings are best immunized during the breastfeeding stage first given the input of colostrum transfer factors and then immunoglobulins, from breast milk. When breastfeeding ends, the supply of such important immune factors, which will not be recovered again, also ends. Bioprotein+ is a food alternative that again allows access to such important nutrients in the form of a shake to be consumed daily.
2. 100% labile body protein recovery (100% cell regeneration). To date, in order to achieve an amino acid input and a biological value close to the daily protein requirements of human nutrition, the only alternative was to combine different protein sources, without this entailing a 100% recovery, i.e., total cell regeneration.
In practice, this also represents other additional limitations for the average consumer, such as unawareness of the most suitable types of foods to be combined or the exact proportions thereof for their effective amino acid complementation.
In Bioprotein+ the protein sources biologically enhanced bovine colostrum; ii. egg albumin; soy protein isolate; and, iv. whey protein concentrate) have been combined proportions such that they provide 100% bioavailability, i.e., they assure for the organism 100% labile body protein recovery and thereby allows 100% body cell regeneration.
The compound called Bioprotein+ is a bionutritional food having immunological and nutraceutical capabilities that are unmatched worldwide.
1. Calidad de las proteínas y Evaluación de su Ingestión y de los Aminoácidos Esenciales en un Grupo de Embarazadas. Rev Cubana Aliment Nutr 2000; 14(1):28-32.
2. Balance de la Proteína y Lisina de Origen Animal en la dicta del Chileno. Cien. Inv. Agr. 31(3): 145-154.2004.
Colostrum is the first liquid produced by a mother's mammary glands within the first 24-48 hours after a baby is born. Colostrum, provides immune and growth factors essential for life that assure the newborn's health and vitality. Colostrum is so important that most babies born to any animal would die if they could not take it.
After puberty, the body slowly begins to reduce its production of the growth hormone, necessary for the reproduction of virtually all the cells and tissues in the body. It has been demonstrated that at 80 years of age, the body produces virtually no growth hormone, and therefore, from that moment on humans age quickly and die. In fact, colostrum growth factors are the hormones that stimulate normal reproduction of cell tissue. The normal reproduction of cells means slow aging and the prevention of cancer, wrinkles and general weakness.
Several years ago, The New England Journal of Medicine expressed that supplementing growth hormones to their most suitable levels could slow down the processes of aging and possibly stop them.
The onset of almost all diseases, whether they are infectious or degenerative, including cancer and heart diseases, is preceded or accompanied by a decrease in immune system functions. Studies demonstrate that colostrum contains powerful factors (immunoglobulins, lactoferrin, cytokines and interferon) that boost the immune reaction. This is another advantage of Bioprotein+from ProLife. The colostrum used in its formulation has an immunoglobulin (IgG) content that is five times greater than that of human colostrum.
Colostrum also contains PRP (Proline-rich Peptides) which according to medical studies aid in strengthening a hypoactive immune system, particularly when it has 100% bioavailability. PRPs help the thymus restore its optimal operating capacity. This gland produces T-cells that fight against viruses and antigens. The PRPs found in colostrum also help stabilize hyperactive immune system in autoimmune diseases. This makes colostrum extremely effective against diseases such as chronic fatigue syndrome, fibromyalgia, multiple sclerosis, rheumatoid arthritis, lupus and scleroderma.
According to various serious publications on bodybuilding colostrum is extremely potent in generating muscle mass when it is accompanied by suitable exercises.
Research has demonstrated that humans readily assimilate bovine colostrum, particularly if said bovine colostrum has a suitable chemical score. It is also known that only bovine colostrum contains glycoproteins and protease inhibitors which are extremely effective in protecting the active components of colostrum against the destructive effect of digestive enzymes and stomach acids of an adult human.
According to Dr. Robert Preston of the US National Institute on Nutrition Research, “colostrum is so innocuous that it has been made by nature as the first food for newborns. It would be difficult to imagine a more natural or beneficial substance”.
Intestinal permeability (leaky gut syndrome) and irritable bowel syndrome occur primarily because the bowel has been exposed to infectious agents such as bacteria, viruses, fungi (candidiasis), parasites and various toxins. There are other causes as well, including a poor diet, drinking alcoholic beverages, anti-inflammatory drugs, cytotoxic drugs and body stress reactions to situations such as heart attacks, surgeries and any other form of shock.
This condition can lead to multiple problems which are very frequent, such as diarrhea, poor assimilation of food, as well as food allergies. It is also often associated with more serious illnesses, such as Crohn's Disease. Intestinal symptoms of this type are furthermore often a component of many serious autoimmune diseases such as muscular dystrophy, fibromyalgia and scleroderma. In fact, many doctors believe that most diseases originate in the bowel.
The studies demonstrate that colostrum can stop leaky gut syndrome, with its unique combination of immune and growth factors that seem to have been custom designed by nature as a remedy for this disease, Immunoglobulins (IgA, IgG and IgM), lactoferrin and other immune factors can inhibit the reproduction of invading pathogens (infections) and protect against toxins. The epithelial growth factor of colostrum stimulates the reparation of intestinal membranes at the cellular level. The anti-inflammatory action it provokes reduces cell spacing, thereby reducing hyperpermeability.
Given that the bovine colostrum of Bioprotein+ reduces intestinal permeability and its high bioavailability greatly increases its assimilation, it also increases the efficacy of all other nutrients normally consumed in the diet.
Arthritis is almost always accompanied by inflammation. Inflammation and the pain that accompanies it are, in fact, a mild form of disease or of a deficient autoimmune operation. It is the result of the attack started by the Immune system against antigens after this response is no longer needed. Many much more serious autoimmune diseases, such as muscular dystrophy (Lou Gehrig's disease) and scleroderma also derive from a hyperactive immune system.
Recent studies have demonstrated that natural compounds containing sulfur, such as glucosamine sulfate, have a beneficial effect on inflammation, especially inflammation caused by arthritis. Colostrum is an excellent source of these micronutrients containing sulfur, including “MSM”, or methylsulfonylmethane, which has also garnered a great deal of international attention as of late. In fact, colostrum is one of the sources richest in MSMs known today. It also has other powerful components, including two of the strongest anti-inflammatory components. This gives it a great deal more of anti-inflammatory strength than sulfur-containing components alone.
Studies demonstrate that the transforming growth factor) (TgF) contained in colostrum can help prevent osteoporosis.
Osteoclasts are cells that dissolve bone, undermining is structure and causing porosity and loss of bone strength which is called osteoporosis. In turn, osteoblasts are the cells that build bone. As one ages, the number of osteoblasts drops and the number of osteoclasts increases. This is especially true in postmenopausal women because it has been demonstrated that a drop in estrogen levels causes an increase in the number of osteoclasts.
A study in Natural Medicine demonstrates that TgF-B factor which is naturally found in colostrum alone is also produced naturally by osteoblasts. The study also demonstrates that TgF-B dramatically increases cell apoptosis (cell death) among osteoclasts. The study indicates that TgF-B could reduce the risk of this disease.
According to clinical studies, colostrum may be the most potent natural substance that has been discovered to help athletes obtain desired results.
In fact, many bodybuilders and professional trainers say that colostrum is the most effective muscle development agent they have ever used.
In his article in Ironman (certified and specialized bodybuilding magazine), Daniel Shawn states that IgG-1 (insulin-like growth factor) in colostrum “has a greater anabolic effect than any known compound, including steroids”.
IgG-1 factor can “promote muscle growth by itself”, Steve Schwade, assistant editor of Muscle & Fitness, writes in his issue from May 1992. “Bovine colostrum has an IgG-1 concentration that is higher than human colostrum”, he continues, “and its structure is virtually identical. Human IgG-1 and bovine IgG-1 differ only in three of the 67 amino acids making up the molecule of this factor. Because of that similarity, bovine IgG-1 is as potent as human. G-1.”
Mr. Schwade continues to mention current studies that have demonstrated that colostrum makes proteins break down more slowly and “ . . . stimulates the transport of glucose in to the muscle”, which means that muscles can more efficiently use the nutritive substances that are available to it.
With respect to fat metabolism, colostrum growth factors “cause a switch from using carbohydrates to using fat. This does not mean that one can take in more fat, but it does mean that the body can burn more of it, including the fat that the body manufactures from carbohydrates and proteins that one eats, and therefore more efficiently produce fuel for cells”, Mr. Schwade remarks.
In conclusion, he stated: “In summary, growth factors (in colostrum) speed up protein synthesis and slow down protein catabolism (breaking down proteins), which leads to an increase in lean muscle mass without the corresponding increase in adipose tissue”.
And once again, Daniel Shawn of Ironman, states: “Quite simply, IgG-1 factor is the ultimate growth factor made up of anabolic peptides”.
More studies have recently been conducted with athletes. In his article in Nutrition Science News in May 1996, Dr. Edmund Burke reports on research conducted with the Finish Olympic Ski Team. “The athletes trained very hard and their creatine kinase levels were analyzed every seven days. Creatine kinase is an extremely important muscle enzyme that has been proven to be a signal of damage in muscle cells which is detected in the blood. Therefore, when creatine levels increase, it is often indicative of significant muscle damage. Compared with the members the team that took placebos, the athletes who drank a beverage made with colostrum experienced approximately only if the increase in creatine kinase levels four days after having performed tiring exercises”. In the subjective aspect, the athletes also said that the felt less tired and that their performance seemed to nave improved.
In that same article, Burke continues to say tint colostrum also “improves athletic performance through the bowel”. Colostrum increases the assimilation of nutrients through these and thereby improves the efficiency of the absorption of carbohydrates and amino acids. Growth factors containing colostrum also “seal” the digestive pathways and protect them against ulcers, which would reduce the efficiency of absorption.
Therefore, when one takes colostrum, more nutrients from food can be used as fuel for exercise whether the exercise is cardiovascular or a bodybuilding exercise.
As mentioned in the specification, proteins naturally have a significant limitation in their biological value (BV). According to the FAO, whey protein has the highest BV: 95% (
On the other hand, even though colostrum has a very complete amino acid profile and proven positive effects on health, it does not reach 100% bioavailability either.
The permanent concern among doctors, nutritionists and other health professionals has been to find or formulate a protein compound of a natural origin which, when administered parenterally, allows protein metabolism in the organism which assures 100% labile body protein restoration and thus allows 100% cell regeneration in the human organism. If a health promoting effect is considered together with the foregoing, a functional food having nutraceutical capabilities that are unmatched worldwide would be obtained.
To show this point,
The starting point of the present invention is based on the assumption that by combining different protein sources, the limiting amino acid of one source could be provided by another source in a sufficient amount.
According to the medical evidence available, colostrum with a 100% chemical score can provide the human organism with the following benefits:
Regenerate and speed up the normal growth of muscle tissues, bones, cartilage, collagen in the skin and nervous tissues.
Help burn fat by using it as a fuel instead of using muscle tissue while fasting (and in a dietary regimen).
Help develop and maintain lean muscle tissue.
Repair the body's genetic material: DNA and RNA.
Stabilize and regulate blood sugar levels.
Control infection and pain associated with gingivitis, sensitive teeth and dental procedures.
Help regulate blood glucose levels and the chemical substances in the brain that keep people alert and facilitate concentration.
Help regulate chemical substances that give people a feeling of well-being and heighten one's mood.
Lactobacillus
Casei Strain
| Number | Date | Country | Kind |
|---|---|---|---|
| 1340-2011/DIN | Jul 2011 | PE | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/PE2012/000002 | 7/12/2012 | WO | 00 | 1/13/2014 |
