Preparation of an innovative 3-component powder preparation with tribiotically optimized overall effect

Abstract

Preparation of an innovative multi-component powder mixture with tribiotically optimized overall effect, characterized by the fact that sugar reduction and a creamy texture of the finished diet shakes are achieved with the addition of RS 4 (oat beta-glucan) and / or equivalent galactooligosaccharides (GOS concentrate, HMOs).

Description

[0001] The state of the art is utility model DE 20 2022 001 692.1.

[0002] For the first time, this synbiotic formula allows for the highest possible dosage of ideally suited soluble fibers such as resistant dextrin (RS4) and oat beta-glucan, HMOs, and selected probiotic cultures, combined with high-quality protein powder, in a single product. Only this fixed combination enables the delivery of highly effective amounts of short-chain fatty acids like butyrate, propionate, and acetate to the large intestine, with their proven health-enhancing effects such as increased satiety and improved insulin utilization, as detailed below.

[0003] If probiotics are used as a single substitute, in the absence of sufficient fiber, no or only insufficient fatty acid concentrations can be fermented; this fact is explained in more detail by the work of science journalist and Spiegel author Jörg Blech - explained in more detail below.

[0004] This current application is a dynamic development of the aforementioned patent. Innovative additional advantages have been realized: a novel multi-species culture combination has been developed with the assistance of the Microecological Institute in Herborn. The overall synbiotic effect is optimized by incorporating a protein component into the formulation.

[0005] During the extensive trials to develop a readily applicable overall mixture, new raw materials were tested, which are now to be secured with additional protection claims through this application.

[0006] Since the innovative formula can also metabolize satiety hormones, offering a clear advantage in effectiveness compared to conventional diet shakes used as meal replacements, a patent application is specifically intended to safeguard this innovative and superior efficacy. The necessary substitution of the required vitamins and minerals into a daily ration is regulated, among other things, in Section 14a of the German Dietary Foods Ordinance. These vital substances can therefore be added to the existing formula.

[0007] In addition, test trials have successfully demonstrated the ability to mix the probiotic cultures into the powder mixture as an inert preparation in the form of innovative microencapsulated granules.

[0008] TribioComplete®, as an innovative three-component formulation with a single dose that makes this possible, has a sole representation claim on the healthcare market; an additional capsule intake – stomach acid protection of the bifidocultures – is unnecessary. Explanations regarding the nutritionally valuable raw materials of the novel formula:

[0009] The high amino acid content of the proteins guarantees the well-known health benefits.

[0010] Glycine, a non-essential amino acid, has a protective effect on the mucous membranes of the important colonic mucosa, the direct site of fermentation of the dietary fiber in the formula by the probiotic cultures. The mucosal cells "tuned" by glycine / collagen can produce significantly higher concentrations of valuable short-chain fatty acids.

[0011] Water-soluble dietary fibers such as resistant dextrin and oat beta-glucan are subject to almost complete degradation. Similar to fatty acid synthesis, an average of 0.5 to 0.6 grams of short-chain fatty acids are produced per gram of fermentable dietary fiber. Fatty acid synthesis:

[0012] On average, 0.5 to 0.6 g of short-chain fatty acids (CCFAs) are produced per gram of fermentable dietary fiber. The molar ratio of acetate, propionate, and butyrate is approximately 60:20:15. Dietary fiber provides energy through the formation of short-chain fatty acids ( ~ 2 kcal / g fiber). Recipe innovation DE 20 2022 001 692.1

[0013] 8 grams of resistant dextrin / RS 4, and 6 grams of oat beta-glucan, 6 grams of PHGG or HMOs, thus producing a total of 20 grams of almost completely fermentable soluble fiber according to the fatty acid synthesis described above: 20 grams of fiber x 0.6 grams = 12 grams of short-chain fatty acids. 12 grams of short-chain fatty acids contain, according to molar ratio: 7.2 grams of acetate, 2.4 grams of propionate, approx. 1.6 grams of butyrate

[0014] These high concentrations of the aforementioned KKFS, achieved through the innovative formula, deliver up to 3 times higher amounts of the clinically proven health-improving KKFS in a single serving, in direct comparison to capsule preparations. Main functions of the KKFS

[0015] In the large intestine, FOS and RS4 are broken down by bifidobacteria and lactic acid bacteria through fermentation. These bacteria require oat beta-glucan and resistant dextrin for their own growth.

[0016] During this fermentation process, the ketoacids (K-FAs) are formed. Acetic acid, propionic acid, and butyric acid are the most abundant K-FAs in the large intestine (90-95%).

[0017] These KKFS lower the pH value in the large intestine, thereby preventing the growth and survival of pathogens, and optimizing the growth of beneficial bacteria, bifidobacteria and lactic acid bacteria.

[0018] The bifidobacteria cultures multiply by a factor of 4 to 10 – reaching concentrations of up to 10 billion CFU – comparable to the values ​​of Yakult. ® - here is the L-Shirota culture. KKFS: Acetate, propionate, butyrate - each with its own effects.

[0019] Butyrate has a beneficial effect on the health of the colon and is an energy source for the epithelial cells / cell layers on the intestinal wall of the colon.

[0020] Butyrate makes the intestinal wall less permeable by increasing mucus secretion, thus enhancing its preventive effect against diseases – including protective against cancer!

[0021] Furthermore, butyrate promotes normal cell differentiation (specialization) and proliferation (multiplication). KKFS support the regulation of sodium and water absorption, thereby increasing the absorption of calcium and other minerals.

[0022] Thus, by substituting the present formula / synbiotic diet shake, the problem of insufficient KKFS levels in the large intestine can be significantly improved, and for the first time probably even eliminated.

[0023] Butyrate substitutions with high doses, such as with the present formulation, have been shown in studies to increase energy expenditure and mitochondrial function.

[0024] Furthermore, butyrate led to improved insulin sensitivity, the sensitivity of body cells / insulin receptors to insulin.

[0025] Low insulin sensitivity is also known as insulin resistance. KKFS thus achieve a preventive effect against manifest type 2 diabetes.

[0026] The smallest components of proteins are amino acids. Besides triggering the release of insulin, these also lead to the release of cholecystokinin, another potent satiety hormone.

[0027] The amino acid leucine is even able to trigger satiety stimuli directly in the brain.

[0028] Proteins also influence a whole range of other orexigenic substances. The highly diverse satiating mechanisms of proteins lead many experts to believe that protein-rich meals are the most satiating.

[0029] For these reasons, the inventive formulation was supplemented by the simultaneous addition of an egg protein component. According to our own research, there is no other formulation that has been tested and is composed of the most bioavailable / ideally metabolizable soluble dietary fibers, the best fermentation cultures, and a satiating protein component.

[0030] This innovative formula makes it possible for the first time to produce targeted high concentrations of satiety hormones in the small drinking quantity of 250 ml of diet shake.

[0031] The powder mixture according to the invention not only produces significant satiating effects, but is also ideally suited for diabetics and obese patients. 1. According to various studies, short-chain fatty acids could help reduce stress levels in the body, prevent or alleviate diabetes, strengthen bones and reduce joint inflammation, thus positively influencing osteoporosis and / or arthritis. 2. Research results suggest that short-chain fatty acids help to favorably influence the course of autoimmune diseases such as rheumatism, multiple sclerosis, psoriasis, and the intestinal disease Crohn's disease.

[0032] It is now also known that short-chain fatty acids better balance the body's defenses and thus strengthen the immune system. They can also help lower cholesterol levels, reduce appetite, and protect our bodies from attacks on our own cells.

[0033] Furthermore, short-chain fatty acids (SCFAs) can help prevent cardiovascular disease. In addition, SCFAs are key to a healthy gut microbiome.

[0034] More than two-thirds of our immune system cells are located there.

[0035] The formulation according to the invention doses optimally usable prebiotic fibers with the best probiotic fermentation cultures in a portion volume of only 250 ml.

[0036] This best overall synbiotic effect to date is complemented by the important simultaneous protein intake; this 3-drug combination is the first of its kind on the self-medication market.

[0037] The formulation according to the invention consists of: 1. the highly fermentable soluble dietary fiber oat beta-glucan 2. Resistant dextrin RS 4- is considered the best butyrate former and PHGG and / or HMOs 3. a probiotic multi-species culture mixture 4. a bioavailable protein component with a tailored amino acid profile.

[0038] These powdered raw materials are thoroughly mixed and ideally packaged in environmentally friendly sachets. Two 30-gram sachets are taken as a shake, one in the morning and one in the evening. Suitable liquids for the shake include oat milk, almond milk, diluted fruit juices, vegetable juices, smoothies, and more.

[0039] The resulting drink, prepared with a single dose of the inventive formula, is an innovative combination product. For the first time, consumers can directly benefit from the clinically proven health-enhancing properties of the best dietary fibers, which are metabolized through fermentation by probiotic multi-species cultures, in a shake.

[0040] The additional protein intake, in the same formula, is further optimized by the effects of the amino acids, a fact recognized by nutritionists. A comparable combination product is not yet commercially available.

[0041] One dose of these BS concentrates produces approximately 12 grams of available KKFS.

[0042] These KKFS lower the pH value in the large intestine, thereby promoting the growth and survival of pathogens, as well as the growth of beneficial bacteria, bifidobacteria and lactic acid bacteria.

[0043] The Bifidobacteria cultures multiply by a factor of 4 to 10 – reaching concentrations of up to 10 billion – comparable to the values ​​of Yakult. ® - here is the L-Shirota culture.

[0044] 1. Protein intake in the same formula, additionally optimized by the effects of the amino acids, recognized by nutritionists.

[0045] Thanks to the introduction of a new raw material and extensive compatibility tests, a measurably more effective formulation variant in durable powder form was implemented through inventive steps.

[0046] Dietary fiber supports the growth of the intestinal flora by serving as a food source for healthy intestinal bacteria, reflexively lowering the oxygen content in the intestine through increased fermentation rates.

[0047] Dietary fiber, which is found in all plants such as vegetables, fruits or nuts, serves as a food source for the intestinal flora and thus supports the growth of health-promoting intestinal bacteria.

[0048] In this way, the oxygen content in the intestinal lumen decreases, thereby inhibiting the growth of oxygen-dependent pathogenic germs such as Escherichia coli and Salmonella terica.

[0049] Health-promoting bacteria such as lactic acid bifidobacteria, on the other hand, grow significantly better under low-oxygen conditions. More beneficial bacteria, in turn, mean additional beneficial bacteria that break down dietary fiber into butyrate, thus further promoting the oxygen-reducing process in a self-reinforcing cycle.

[0050] This creates a vicious cycle for harmful bacteria, but it is a blessing for our health. https: / / science.sciencemag.org / content / sci / 357 / 6351 / 570 / F1.large.jpg?download=tru Abstract: The study confirmed a reduction in butyrate-producing microbes, which decreased epithelial signaling through the intracellular butyrate sensor peroxisome proliferator-activated receptor (PPAR-).

[0051] The nitrate level increased in the large intestine lumen due to the epithelial expression of Nos2, the gene encoding inducible nitric oxide synthase, in the absence of PPAR-γ signaling.

[0052] Microbiota-induced PPAR-γ signaling also limits the luminal bioavailability of oxygen by driving the energy metabolism of colonic epithelial cells towards β-oxidation.

[0053] Therefore, microbiotic-activated PPAR-γ signaling is a homeostatic pathway that prevents dysbiotic expansion of potentially pathogenic Escherichia and Salmonella* by significantly reducing the bioavailability of respiratory electron acceptors for Enterobacteriaceae in the lumen of the colon.

[0054] * This is proof of the efficacy of the present synbiotic formula for reducing side effects in Metformin patients, because Metformin increases E. coli bacteria, which are the cause of pronounced gastrointestinal complaints.

[0055] In general, the innovative reduction of oxygen concentrations at the mucous membranes of the large intestine by the inventive formulation can be cited as the fermentation guarantee for significantly increased short-chain fatty acid synthesis rates.

[0056] The Spiegel Online article “Superorgan Gut” by science writer Jörg Blech states: Only by minimizing oxygen gas concentrations at the intestinal mucosa can high amounts of short-chain fatty acids be efficiently absorbed into the body.

[0057] To utilize these ideal fermentation conditions, only the simultaneous administration of suitable probiotic cultures combined with guaranteed highly fermentable soluble fibers such as resistant dextrin, HMOs, or a synbiotic combination like that of the present formulation is possible.

[0058] Probiotic capsules alone cannot achieve this, according to author Jörg Blech.

[0059] Even high-dose probiotic capsules, without suitable dietary fiber for fermentation in the large intestine, do not achieve comparable levels of KKFS (colloidal fatty acids) – in direct comparison with a synbiotic dosage such as TribioComplete®, the inventive formulation!

[0060] The active ingredients in the formula (a combination of highly fermentable dietary fiber plus ideally suited multi-species cultures) are fermented on the intestinal mucosa.

[0061] The resulting high butyrate concentrations activate the mucosal cells of the large intestine, leading to significant increases in oxygen absorption.

[0062] Lower oxygen gas concentrations increase the number of bifidocultures by a factor of 10, which in turn synthesize more butyrate from the fiber substrates.

[0063] E. coli needs oxygen; the increased reduction of oxygen eliminates equivalent amounts of E. coli, thus minimizing / eliminating intestinal intolerances!

[0064] The antidiabetic drug metformin induces higher concentrations of E. coli intestinal bacteria.

[0065] Approximately one-third of the over 8 million type II diabetics in Germany are treated with metformin; approximately one-third of metformin patients suffer from often pronounced intestinal intolerances.

[0066] Calculated, the approximately 700,000 patients who take this formula daily could minimize bothersome Metformin side effects through continuous use; at the same time, the formula lowers blood sugar levels, thus reducing antidiabetic drug dosages after medical checkups.

[0067] The short-chain fatty acid butyrate is produced by intestinal bacteria and is the main energy source for intestinal cells. Butyrate also regulates the intestinal immune system and influences various metabolic processes in the body, for example in the liver and brain.

[0068] A chronic deficiency of butyrate is associated with diseases such as type 2 diabetes, obesity and / or cardiovascular diseases.

[0069] Furthermore, low butyrate concentrations in the large intestine increase the risk of infectious diseases.

[0070] Researchers at the Helmholtz Centre for Infection Research (HZI) have now identified butyrate-producing gut bacteria. In their investigations, the team led by Dr. Marius Vital discovered that, on average, over 20 different butyrate-producing species are found in the gut, capable of specifically adapting to environmental conditions. Far-reaching consequences of a butyrate deficiency

[0071] In addition, the analysis confirmed that a deficiency of butyrate-producing bacteria is associated with various common diseases such as diabetes or obesity, reports the HZI.

[0072] In total, the researchers analyzed 2387 transcriptome samples. For the data analysis, they combined information from various publicly available datasets of patients with different diseases such as diabetes, obesity, or liver cirrhosis.

[0073] This allowed them to identify key ecological characteristics of this functional bacterial community.

[0074] “The butyrate-producing community in the gut consists of many bacterial strains and forms a biochemically diverse group,” Vital is quoted as saying in the HZI press release. Many bacterial species are involved.

[0075] "The great diversity of butyrate-producing bacteria helps to maintain the functional stability of the intestinal microbiome and also reduces serious disturbances such as antibiotic treatment," reports Vital.

[0076] Diet also influences the presence of butyrate-producing bacteria, which increase with a high-fiber diet compared to excessive consumption of meat-based foods. The findings could help in the future to develop individually tailored medications to prevent functional gut dysbiosis and thus reduce the incidence of disease, according to the HZI.

[0077] Studies show that butyrate increases the secretion of gut hormones such as glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). GLP-1 increases insulin production and reduces glucagon production in the pancreas. PYY increases glucose uptake in both muscles and fat tissue.

[0078] Increased production of short-chain fatty acids, including butyrate, in the large intestine increases the release of these intestinal hormones, suggesting potential benefits for controlling blood sugar levels and preventing weight gain. Rationale for the selection of probiotic strains for the formulation according to the invention

[0079] Advisory support from Professor Andreas Schwiertz - Microecological Institute Herborn Akkermansia muciniphila* is an important physiological intestinal bacterium for maintaining a healthy intestinal mucosa and the preservation of the intestinal barrier.

[0080] Furthermore, studies have shown that Akkermansia muciniphila is reduced in numerous diseases (overweight, neurodermatitis or allergies).

[0081] Akkermansia muciniphila is an intestinal bacterium discovered in 2004. It is present in the human intestinal mucosa and likely makes a significant contribution to a healthy gut flora. This oxygen-sensitive bacterium belongs to the phylum Verrurcomicrobia.

[0082] How can the growth of Akkermansia muciniphila be promoted?

[0083] Measures for the propagation of A. muciniphila and Faecalibacterium prausnitzii

[0084] To promote Faecalibacterium, an increased intake of complex dietary fiber such as inulin and / or oligofructose, which is found in foods such as chicory, onions, Jerusalem artichokes and artichokes, is recommended.

[0085] Prebiotics containing inulin are also suitable *

[0086] * Jerusalem artichokes contain 12.5 g of fiber, twice as much as whole-grain bread. 100 grams of Jerusalem artichoke tuber contain approximately 12.5 grams of fructooligosaccharides.

[0087] The present formula contains, without plant-specific quality variations, 20 grams of valuable crop growth-promoting dietary fiber RS ​​4, resistant dextrin and oat beta-glucan.

[0088] The evaluation of Faecalibacterium prausnitzii should always be carried out in conjunction with Akkermansia muciniphila.

[0089] Since the substrates provided by the mucin degradation of A. muciniphila serve as an important food source for F. prausnitzii, the primary goal should be to increase the amount of A. muciniphila.

[0090] Unfortunately, there are currently no probiotics available that directly contain Akkermansia muciniiphila.

[0091] Therefore, reproduction can only be positively influenced by targeted nutrition.

[0092] These physiological intestinal bacteria must be indirectly promoted through certain prebiotics such as resistant starch / resistant dextrin - this is the reason for using RS 4 in the formulation according to the invention.

[0093] Furthermore, other probiotic strains such as Lactobacillus plantarum, L. rhamnosus, Bifidobacterium breve, B. animalis supbs. lactis or B. longum; Bifidobacterium adolescentis can favorably influence the conditions in the intestine and thereby promote the growth of Akkermansia mucini-philia.

[0094] Butyric acid, or butyrate as it is correctly called, is produced exclusively by the intestinal flora. One of the most important producers is *F. prausnitzii*. Butyric acid and its derivatives are the main energy source for the intestinal epithelium.

[0095] Butyric acid also regulates cell proliferation, differentiation, and apoptosis. Furthermore, butyrate has an anti-inflammatory effect.

[0096] Butyric acid also plays a crucial role in the progression of Crohn's disease. One of the key causes of chronic inflammation is the penetration of intestinal flora into the epithelium. Butyric acid prevents this by strengthening the connections between cells, the so-called tight junctions, thus maintaining the integrity of the intestinal barrier. Saccharolytic bacteria

[0097] Saccharolytic bacteria in the intestine are responsible for the breakdown of complex poly- and oligosaccharides such as resistant starch / dextrin.

[0098] The lactic acid produced during the splitting process serves as a basis for the fermentation of butyric acid by other bacteria such as Ruminococcus bromii or Faecalibacterium prausnitzii.

[0099] Bifidobacterium adolescentis plays a key role in this, as documented in a study that was conducted with healthy subjects. (Venkataraman et al. Microbiome 2016).Sources Dao MC, Everard A, Aron-Wisnewsky J et al (2016) Akkermansia muciniphila and improved metabolic health during a dietary intervention in obesity: Relationship with gut microbiome richness and ecology. Gut. 65(3):426-36. https: / / www.ncbi.nlm.nih.gov / pubmed / 26100928 Leitner C (2019) Study on gut flora - How a bacterium could help with weight loss. Spiegel Bifidobacterium bifidum Bifidobacterium longum ssp. longum Bifidobacterium longum ssp. breve Bifidobacterium infantis Lactobacillus rhamnosus Lactobacillus acidophilus

[0100] The use of individual stems varies depending on requirements.

[0101] The bacterial densities of the individual strains vary between 10⁶ CFU and 10⁻⁶ CFU, depending on requirements. They synthesize various biologically active substances, including: Thiamine (B1) Riboflavin (B2) Pyridoxine (B6) Folic acid (B9) Cyanocobalamin (B12) Menaquinone (K2) Nicotine Justification for the selection of a newly substituted protein component in the DE 20 2020 002 846 formulation Fiber and protein keep you feeling full for a very long time.

[0102] Dietary fiber is ideal for promoting satiety because it swells, increasing its volume in the stomach and stretching it. It also provides complex carbohydrates that cause blood sugar levels to rise slowly and steadily over a longer period.

[0103] Protein is also a good ally in the fight against excess weight, because protein-rich foods not only keep you full for a long time, they are also real fat burners.

[0104] By metabolizing proteins, the organism reduces its calorie balance through a corresponding increase in energy expenditure.

[0105] With regular dosing of the inventive formulation, weight loss is optimized by the dietary fiber, subtracting from the increased energy consumption of protein metabolism due to the new protein dosage of the present tribiotic mixture.

[0106] According to research, the combined and additive effects of the present 3-component powder preparation described above are implemented for the first time in such a high dose and with such reliable efficacy in a final product, representing an inventive step. The body's own protein management

[0107] After consuming protein-rich foods, the digestive system breaks down the ingested protein into amino acids. These pass through the intestinal wall into the bloodstream, are synthesized in the liver, and then transported by the blood to every cell in the body.

[0108] Cells are free to absorb the necessary amino acids, as demand determines which combinations are needed for cell regeneration or repair, and for the synthesis of enzymes, antibodies, hormones, and blood cells. Protein biosynthesis is subject to the hormonally controlled, characteristic process of building genetically determined hereditary information, specific to cells and tissues.

[0109] What function do amino acids perform in the organism? • Amino acids are indispensable triggers and starter substances for the smooth functioning of all metabolic processes. • Amino acids play a fundamental role as building blocks for the body's own defense system. • Amino acids are an essential component of all cell membranes and are therefore indispensable for transport and receptor functions. • Amino acids, as carriers of unadulterated cell regeneration and repair, are comparable to parchment paper on which the genetic information is written. • Without amino acids, every muscle is doomed to stagnate, as muscle contraction would not be possible without proteins. • Amino acids ensure the transport of hemoglobin, oxygen, vitamins and minerals in connective tissue. • Different combinations of amino acids exert hormone functions. • The complete range of essential and non-essential amino acids creates the basis for a reliable immunological balance. The new formula for optimizing the immune system: amino acids

[0110] The human body requires a complete supply of amino acids to ensure the immune system has a daily supply of new energy. After all, all antibodies are made entirely from proteins.

[0111] This applies both to the prevention of diseases that a strong immune system can handle, and to the accompanying treatment of a disease when healing and relief are to be accelerated.

[0112] The complex immune system requires an optimal supply of amino acids for the production of specific immune proteins (immunoglobulins).

[0113] In this way, the different control centers of the immune system can perform their protective tasks.

[0114] An unimaginably large number of immune cells must be replenished and renewed daily. This is especially true for the "nursery" of the immune system, the human gut.

[0115] More than 80 percent of the cells required for the immune system are built up in the mucous membrane of the intestine. Alarm signals from the immune system

[0116] Long-term treatment with antibiotics, as well as chemotherapy and radiation therapy, but especially chronic gastrointestinal diseases, weaken the immune system in the intestinal area in the long term.

[0117] Even a malnutrition can make the intestinal mucosa permeable to certain bacteria, thus minimizing its defense function.

[0118] The following amino acids play a crucial role in building and maintaining the immune system in the gut: arginine, cysteine, glutamine, glycine, methionine and taurine.

[0119] Amino acids support and guarantee protein synthesis through the formation of antibodies and immunoglobulins. In combination with vitamins and trace elements, they also regenerate the intestinal mucosa, thereby strengthening the immune system of the entire organism.

[0120] Nutritionist and immunologist Dr. Claus Muss emphasizes: "Amino acid therapy represents an essential pillar of immunomodulation in clinical practice." Effects of amino acids in the organism • Amino acids are indispensable triggers and starter substances for the smooth functioning of all metabolic processes. • Amino acids play a fundamental role as building blocks for the body's own defense system. • Amino acids are an essential component of all cell membranes and are therefore indispensable for transport and receptor functions. • Amino acids, as carriers of unadulterated cell regeneration and repair, are comparable to parchment paper on which the genetic information is written. • Without amino acids, every muscle is doomed to stagnate, as muscle contraction would not be possible without proteins. • Amino acids ensure the transport of hemoglobin, oxygen, vitamins and minerals in connective tissue. • Different combinations of amino acids exert hormone functions. • The complete range of essential and non-essential amino acids creates the basis for reliable immunological balance. Effects of amino acids in immune nutrition

[0121] Although all amino acids – both essential and non-essential – are indispensable, some amino acids have a direct influence on the body's defenses: Arginine: This immune-boosting amino acid influences protein synthesis and thus counteracts protein loss (and muscle mass loss) during illness and bed rest. Its antioxidant properties support the stability of the immune system. Lysine: Together with arginine, lysine stabilizes the immune system. This is demonstrated, among other things, by lysine's pronounced antiviral effect. Cysteine: These building blocks are needed for maintaining and building the organism's structure. Together with glutamine and glycine, it has a pronounced antioxidant effect. Therefore, a healthy immune system diet includes the regular intake of cysteine, glutamine, and glycine. Glycine: This amino acid is required for the formation of immunoglobulins and antibodies and is therefore essential for maintaining a stable immune system.

[0122] Glycine is also involved in the liver's detoxification metabolism.

[0123] Methionine: This amino acid supports wound healing and the treatment of immune deficiencies. Methionine is one of the substances necessary for the body's own synthesis of cysteine ​​and taurine.

[0124] Confirmation of the innovative effectiveness of the inventive formulation - documented by nutritionists: Scientific evaluation of this inventive formulation TribioComplete®: TribioComplete® with 13 grams of resistant dextrin 7 grams of oat beta-glucan PHGG and / or HMOs Probiotic microencapsulated (Bifido) cultures 40 grams of whey protein for the prevention of diabetes and obesity?

[0125] The formula combines several targeted approaches that can have a preventative effect against diabetes and obesity. The components it contains influence both the gut and metabolism in a potentially synergistic way, with their interaction based on scientifically sound mechanisms. Here is a detailed evaluation: 1. Resistant dextrin (13 g) - promotes SCFA production, alternatively with a proportion of HMOs!

[0126] Resistant dextrin is a fermentable dietary fiber and is metabolized by the gut flora into short-chain fatty acids (SCFAs) – primarily butyrate, propionate, and acetate. These SCFAs have crucial effects on metabolic health: • Blood sugar regulation: Propionate can influence gluconeogenesis in the liver and thus contribute to stabilizing blood sugar levels. • Appetite control: SCFAs interact with gut hormones such as GLP-1 and PYY, which increase feelings of satiety. • Intestinal barrier stabilization: Butyrate strengthens the integrity of the intestinal wall and can prevent "leaky gut", thereby reducing low-grade inflammation. 2. Oat beta-glucan (7 g) - Delays glucose absorption

[0127] Oat beta-glucan is one of the soluble dietary fibers with proven effects on glucose metabolism. • Avoid blood sugar spikes: Oat beta-glucan forms a viscous layer in the intestine, which slows down the absorption of glucose and reduces insulin spikes. • Influence on lipid levels: Studies show that beta-glucans actively lower LDL cholesterol levels, which can also mitigate cardiovascular complications. • Fermentation potential: Betaglucan is also partially fermented by the intestinal flora, resulting in additional SCFA concentrations. 3. Probiotic cultures - Optimizing the microbiome

[0128] The targeted intake of probiotic cultures can positively influence the gut flora and enhance the function of dietary fiber. The following are particularly important: • Bifidobacterium spp.: promotes the growth of beneficial bacteria and the production of propionate. • Lactobacillus spp.: supports intestinal wall integrity and helps regulate inflammatory processes. • Akkermansia muciniphila: a promising candidate for modulating the gut flora, which correlates with improved glucose metabolism and reduced obesity. 4. Whey protein (40 g) - Satiety & metabolic control

[0129] Whey protein provides high-quality protein with a high proportion of leucine, which is central to muscle protein synthesis and insulin regulation. • Promoting muscle mass: Muscle tissue increases energy consumption and improves glucose utilization, which can inhibit adipogenic processes in the long term. • Increased satiety: The intake of whey protein leads to an increased release of GLP-1 and PYY, which inhibits the feeling of hunger. • Direct microbiome interaction: Initial studies suggest that whey protein may modify the gut microbiome by promoting the growth of anti-inflammatory bacteria. Overall assessment & prevention potential

[0130] This formula follows a multimodal approach: Improve gut health - through fermentable fiber & probiotic cultures Reduce inflammatory markers - SCFAs and probiotic microorganisms lower systemic inflammation Optimize glucose metabolism – through beta-glucan-induced delay of glucose uptake Activate muscle metabolism - through whey protein, which enhances satiety and insulin sensitivity.

[0131] These properties make the formula a promising element in the prevention of obesity and diabetes. However, individual adjustment based on age, activity level, and microbiome composition is crucial. Furthermore, it would be beneficial to consider clinical studies on long-term effects and ideal dosage.

[0132] Why are nutritional interventions (including meals with minimal calorie deficits) combined with the simultaneous intake of short-chain fatty acids more effective against obesity and diabetes than weight-loss injections (GLP-1 analogs)? GLP-1 analogs have a sales volume of approximately €1 billion per year! A consistently fiber-rich diet with a slight calorie deficit and simultaneous supplementation of short-chain fatty acids (such as 11 grams of SCFA in TribioComplete®) surpasses weight-loss injections in overall long-term effectiveness for several reasons: 1. Sustainable weight regulation through microbiome modulation Dietary fibers such as inulin, resistant starch, and pectin are fermented in the large intestine by bacteria into acetate, propionate, and butyrate. These small fiber-releasing fatty acids (SCFAs) act systemically as signaling molecules: they increase insulin sensitivity, inhibit lipogenesis in adipose tissue, and activate brown fat, which permanently raises the basal metabolic rate. In contrast, weight-loss injections primarily suppress the feeling of hunger but do not alter the microbiome or energy expenditure beyond the treatment. 2. Physiological satiety and metabolic control SCFAs promote the release of endogenous satiety hormones (GLP-1, peptide YY), but at the same time only moderately regulate gastric emptying. This creates a stable, natural feeling of satiety without the risk of chronic gastroparesis, which can sometimes be triggered by GLP-1 agonists. 3. Fewer side effects, more additional benefits Beyond weight loss, a high-fiber diet leads to improved intestinal barrier function, lower inflammation levels, and a more stable lipid profile—effects that even the cardioprotective benefits of GLP-1 / GIP agonists only partially address. Gastrointestinal discomfort associated with SCFA promotion is mild and accompanied by adaptive microbiome remodeling, whereas weight-loss injections often carry the risk of nausea, gallstones, or pancreatitis. 4. Cost-benefit ratio and quality of life: Prebiotic foods or inexpensive supplements (e.g., resistant starch) cost only a fraction of GLP-1 therapy per month. Users remain independent of injection appointments and doctor-adjusted doses. In the long term, the withdrawal-rebound phenomenon with dramatic weight fluctuations is avoided, provided the dietary plan is maintained (ideal long-term use is achievable thanks to over 500 tasty meals, including ready-made options). Therefore, the Tribio concept offers a high quality of life! 5. Behavioral and lifestyle integration Learning a high-fiber, calorie-controlled diet leads to lasting habit shifts (e.g., regular consumption of vegetables, whole grains, and legumes). With weight-loss injections, the psychological dependence on the medication often persists—without the injection, previous eating habits quickly return (yo-yo effect). In conclusion, in the long term, a moderate reduction in calorie intake combined with targeted SCFA supplementation is more natural, stable and less risky than a costly drug intervention (plus severe side effects).

[0133] The TribioComplete® combination creates a three-stage crossfeeding cascade: a first on the self-medication market! HMOs + PHGG → acetate / lactate → butyrate; β-Glucan → Propionate; Polyphenols → Urolithins. Microencapsulated cultures enhance selectivity, while whey protein optimizes the metabolic response. The result: barrier function, inflammation, glucose, lipids, and satiety improve simultaneously. Sources: Smith et al., “Butyrate and Propionate Effects on Adipose Tissue Metabolism,” Journal of Nutritional Biochemistry, 2023. Mül2ler et al., “Endogenous GLP-1 Release by Dietary Fiber Fermentation,” Gut Microbes, 2024. Al-Aly et al., Systematic analysis of GLP-1-RA: 42 benefits vs. 19 risks, Nature Medicine 2024. www.diabetiker-nds.de2doktorfv.de3www.pharmazeutische-zeitun.de

[0134] Concluding remark: After years of working on the final product / formula, I hope that funding can be secured for an intervention study. With the anticipated improvements in value, I would then like to commission a research project for recognition of the innovation at the German Patent and Trade Mark Office (DPMA). QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 20 2022 001 692.1

[0001] DE 20 2020 002 846

[0101] Cited non-patent literature

[0000] Dao MC, Everard A, Aron-Wisnewsky J et al (2016) Akkermansia muciniphila and improved metabolic health during a dietary intervention in obesity:

[0099] relationship with gut microbiome richness and ecology. Good. 65(3):426-36. https: / / www.ncbi. nlm.nih.gov / pubmed / 26100928

[0099] Smith et al., „Butyrate and Propionate Effects on Adipose Tissue Metabolism“, Journal of Nutritional Biochemistry, 2023. Mül2ler et al., „Endogenous GLP-1 Release by Dietary Fiber Fermentation“, Gut Microbes, 2024. Al-Aly et al., Systematische Analyse zu GLP-1-RA: 42 Vorteile vs. 19 Risiken, Nature Medicine 2024. www.diabetiker-nds.de2doktorfv.de3www.pharmazeutische-zeitun.de

[0133]

Claims

[1] Preparation of an innovative multi-component powder mixture with tribiotically optimized overall effect , characterized by , that the sugar reduction and a creamy texture of the finished diet shakes are achieved with the addition of RS 4 (oat beta-glucan) and / or equivalent galactooligosaccharides (GOS concentrate, HMOs). [2] Preparation according to claim 1, characterized by , that the inventive formulation, through microencapsulation of the cultures, eliminates the need for a probiotic capsule that would otherwise be required when taking the shake. [3] Preparation according to claim 1, characterized by , which is a possible natural sweetener isomaltose / palatinose ® is used [4] Preparation according to claim 1, characterized by that the relative amounts of dietary fiber additives are 5 to 34% in 100 grams of powder preparation. [5] Preparation according to claim 1, characterized by, that oat beta-glucan can be used as a suitable dietary fiber at a rate of 3 to 15% in 100 grams of powder mixture [6] Preparation according to claim 1, characterized by , that in addition to RS 4 supply, an additional 2 to 35% FOS or HMOs (specifically also combined fractions) can be substituted. [7] Preparation according to claim 1, characterized by , that in addition to the above-mentioned FOS, GOS and / or RS 4 quantities, fruit powder preparations are also used in quantities of 1% to 5%. [8] Preparation according to claim 1, characterized by that the matched multi-species cultures with ideally effective CFU concentrations of the individual strains are added to each dose of powder preparation (30 grams in sachets). [9] Preparation according to claim 1, characterized by that all strains of Bifidobacteria cultures, L-Casei, Akkermansia muniphilia, and generally all food-legally approved probiotic cultures in approved CFU values ​​can be used [10] Preparation according to claim 1, characterized by that the single-dose amounts of the cultures can be enclosed as capsules [11] Preparation according to claim 1, characterized by , that protein concentrates, optionally and / or in combination, such as whey protein, whey protein isolate, lactalbumin, low-fat quark powder, casein, milk protein isolates, soy protein, or other vegan protein concentrates, can be added to the formulations in amounts of 30 to 70% in 100 grams of the powder preparation according to the invention. [12] Preparation according to claim 1, characterized by that auxiliary substances such as emulsifiers / binding agents can be added to achieve optimal viscosity in the finished drinking preparations / shakes. [13] Preparation according to claim 1, characterized byThe innovative powder mixture uses citrus fiber powder as a plant-based emulsifier in relative amounts of 0.4 to 3 grams per 100 grams. Citrus fiber is also a physiologically valuable dietary fiber. [14] Preparation according to claim 1, characterized by that vitamins, trace elements, and other plant-based active ingredients such as polyphenols and flavonoids can be added to the powder mixture in nutritionally appropriate amounts. [15] Preparation according to claim 1, characterized by that the dosage amounts of 30 grams can also be filled into sachets [16] Preparation according to claim 1, characterized by , that the diet shake, after appropriate registration / approval, can also be described as a "medical nutritional drink" or a partially balanced diet.