Protein oral preparation

Abstract

The invention relates to a protein oral preparation in the form of a gel, comprising proteins isolated from plant-based substrates, with a focus on pea proteins, and a combination of excipients. The preparation is designed for enhanced nutritional benefits, including reduced inflammation, efficient nutrient delivery through the blood-brain barrier, and targeted muscle nourishment. Key features include a protein concentration of at least 10% by weight, a high water content (60-80%), and the absence of complex sugars to minimize glycemic spikes and insulin resistance. The gel is produced at reduced temperatures to preserve protein bioactivity and employs a simple gelling mechanism with excipients like potassium sorbate, xanthan gum, and sucralose. The invention is suitable for athletes, individuals with dysphagia, oncology patients (adults and children), and older adults experiencing age-related muscle loss. It offers a versatile, cost-effective, and health-conscious alternative to existing protein formulations.

Description

[0001] PROTEIN ORAL PREPARATION

[0002] DESCRIPTION

[0003] Field of the Invention

[0004] This invention relates to a protein oral preparation. In particular, the present disclosure relates to a protein gel composition and its method of preparation, particularly designed to minimize inflammation and enhance nutrient delivery through the blood-brain barrier, while ensuring optimal muscle delivery.

[0005] Background Art

[0006] Protein oral preparations are widely used today in light of the ever-increasing attention of consumers towards a healthy lifestyle in which sport and nutrition are fundamental components. It is also well known that protein preparations are appreciated and sought after based on their components which give them peculiar nutritional properties that vary according to the use and needs of consumers.

[0007] In this context, it is known that there is a particularly strong need to renew the formulations of preparations and to always research new ones in order to further distinguish them from those of the competition. However, currently known protein preparations are not widely appreciated due to their limited nutritional properties and their respective formulations.

[0008] The latter, in fact, are generally characterized by components of chemical origin and a high glycemic load.

[0009] This type of preparation, precisely because of its formulations, is unsuitable for the nutrition of athletes.

[0010] Furthermore, the known energizing preparations are unsuitable for feeding patients suffering from dysphagia.

[0011] In fact, in the face of such disorders, the caloric and nutritional intake assumed daily by these patients plays a fundamental role in their well-being. It is therefore of fundamental importance that the formulations of protein preparations perform, on these patients, in addition to the normal nutritional functions, also beneficial functions.

[0012] The patent literature document CN-A-116671628 discloses a 3D-printed gel made from modified xanthan gum and vegetable protein (pea protein specifically). It's designed for easy swallowing. Such a technique uses a high-temperature process (92°C water bath) to form the gel, potentially denaturing the proteins.

[0013] The patent literature document US2015 / 216199 describes a gummy snack food product with a gel structure containing 10-40% protein (including pea protein). It also includes sweeteners like glucose syrup and sugar alcohols, as well as gelatin as a rheology modifier. Such a technique is not simple enough as a method for achieving the desired texture and protein delivery.

[0014] The patent literature document US-A 1-2019 / 289872 discloses a protein gummy composition with pea protein, isomalto-oligosaccharide syrup (sweetener), and agar (gelling agent). It also includes other ingredients like vegetable glycerin, erythritol, and citric acid. Such a technique involves complex sugars, thus involving glycemic spikes.

[0015] The patent literature document US 2011 / 009348 describes a carbohydrate gel for athletes, which may contain up to 30% vegetable protein (including pea protein). Such a technique involves carbohydrates and complex sugars. Carbohydrates and complex sugars may involve pancreatic overload and insulin resistance.

[0016] Having such drawbacks of the prior art in mind, the present application discloses and teaches how to mitigate such drawbacks.

[0017] Summary of the invention

[0018] The main objective of the present invention is to devise a protein oral preparation which is characterized by improved nutritional values compared to known types of protein preparations.

[0019] Within this objective, one aim is to produce a protein oral preparation which can also be suitable for feeding athletes.

[0020] Another object of the present invention is to devise a protein oral preparation suitable, both from a nutritional and functional point of view, for the nutrition of patients suffering from dysphagia. Another object of the present invention is to devise a protein oral preparation which makes it possible to overcome the aforementioned drawbacks of the known art in the context of a simple, rational solution, which is easy and effective to use and inexpensive.

[0021] The above objects are achieved by the present protein oral preparation according to claim 1.

[0022] Furthermore, the above objects are achieved by the use of proteins isolated from substrates of plant origin according to claim 20.

[0023] Furthermore, the above objects are achieved by an intermediate product for use in preparing a protein gel according to claim 23.

[0024] Furthermore, the above objects are achieved by a method of preparing a protein oral preparation in the form of a gel according to claim 25.

[0025] The invention is suitable for athletes, individuals with dysphagia, oncology patients (adults and children), and older adults experiencing age-related muscle loss. It offers a versatile, cost-effective, and health-conscious alternative to existing protein formulations.

[0026] A first key insight underpinning the invention is the recognition that animal proteins can contribute to inflammation. Inflammation is a critical concern because it underlies a wide spectrum of pathologies, including physical diseases and psychological conditions. Reducing inflammation is therefore paramount to promoting overall health.

[0027] Scientific evidence supporting this insight is found in the work of Cordain et al., "The Western Diet and Lifestyle and Diseases of Civilization" (2005), which highlights how diets rich in processed foods, red meat, and saturated fats can lead to chronic inflammation. Chronic inflammation increases the risk of various diseases, including cardiovascular conditions, diabetes, and certain mental health disorders. Conversely, plant-based diets, when appropriately balanced, are rich in fiber, antioxidants, and essential nutrients, contributing to reduced inflammation.

[0028] A second key insight is the importance of nutrient delivery through the blood-brain barrier (BBB). This barrier selectively regulates the passage of substances from the bloodstream into the brain, making it critical to design nutritional compositions capable of crossing the BBB efficiently. Nutrients that traverse the BBB can have profound effects on neurological health, enhancing cognitive function and mitigating neuroinflammation. A third key insight is that preparations containing sugars, sweeteners, and similar compounds are unsuitable for the nutrition of athletes and oncology patients. This is because such ingredients increase the glycemic index, leading to a rapid need for additional sugar intake. For athletes, this can impair executive functions by causing fluctuations in energy levels. For oncology patients, the elevated and unstable blood sugar levels resulting from such formulations can promote the growth of cancer cells.

[0029] The disclosed protein gel differs from prior art in the following significant ways.

[0030] 1. Lower Processing Temperatures: The gel is manufactured at reduced temperatures to prevent denaturation of proteins. Preserving the bioactivity and structural integrity of proteins enhances their functional benefits and minimizes inflammatory responses associated with altered protein structures.

[0031] 2. Simpler Gelling Mechanism: The gel is formed without the use of alcohols or polyalcohols. Avoiding these agents reduces the potential for adverse interactions with tissues and preserves the natural properties of the protein gel.

[0032] 3. Exclusion of Complex Sugars: The gel avoids the inclusion of complex sugars that can cause glycemic spikes and insulin resistance. This approach ensures metabolic stability and reduces inflammation associated with hyperglycemia and insulin dysregulation. In the context of the present gel, it is essential to highlight that the sugar content is extremely low. Its inclusion in the preparation is strictly functional, serving as a carrier for nanoparticles and other active ingredients, rather than contributing to unnecessary glycemic load.

[0033] 4. Focus on Direct Muscle Delivery: The protein composition is specifically designed for efficient muscle delivery. Direct muscle targeting enhances protein utilization for muscle repair and growth, reducing the likelihood of systemic inflammation from unassimilated proteins.

[0034] The invention provides a novel combination of features that address key limitations of existing protein gels and gummy products. By employing a lower temperature process, the gel retains bioactive properties that are often lost in high-temperature processing. The simpler gelling mechanism eliminates the need for potentially harmful additives. Excluding complex sugars reduces metabolic strain and promotes long-term health. A focus on direct muscle delivery ensures precise and effective nutrient utilization.

[0035] These features can be used independently or in various advantageous combinations, offering a versatile solution to a wide range of nutritional and therapeutic needs.

[0036] Detailed Description of the Invention

[0037] In a first aspect, the present invention relates to a protein oral preparation, in the form of a gel. It is specified that in the context of the present treatment, the term "gel" refers to an almost solid network which is formed following the union of a solution containing gelling molecules and water.

[0038] In this regard, the protein preparation comprises water present in a weight concentration, evaluated with respect to the total weight of the preparation, greater than 50%, preferably between 60% and 80%.

[0039] According to the invention, the protein preparation comprises proteins isolated from one or more substrates of plant origin and one or more excipients.

[0040] It is specified that in the context of the present treatment, the expression "substrate of plant origin" refers to the starting material, free of components of animal origin, and from which the aforementioned proteins are isolated.

[0041] Specifically, the one or more substrates of plant origin are chosen from the list comprising: chickpeas, beans, broad beans, soybeans, peas, lentils, pine nuts, peanuts, almonds, pistachios, cashews, walnuts, hazelnuts, quinoa, broccoli, artichokes, cabbage, spinach, peppers, asparagus, potatoes, chia, hemp, pumpkin and sunflower.

[0042] Therefore, in the continuation of this treatment with the term "proteins" specific reference will be made to proteins of plant origin.

[0043] In accordance with a preferred embodiment of the preparation according to the present invention, the proteins of plant origin are isolated from peas. In other words, the aforementioned proteins are pea proteins.

[0044] It is specified that in the context of the present treatment the expressions "proteins isolated from peas" or "pea proteins" are used interchangeably and refer to a protein powder obtained by extraction from Pisum Savitum seeds commercially available.

[0045] Specifically, these proteins are present in a weight concentration, evaluated with respect to the total weight of the preparation, greater than 10%.

[0046] Preferably, the proteins are present in a weight concentration, evaluated with respect to the total weight of the preparation, between 15% and 30%. The one or more excipients are present in a weight concentration, evaluated with respect to the total weight of the preparation, between 1.5% and 5%.

[0047] Advantageously, the one or more excipients are chosen from the list comprising: preservatives, rheology modifiers, sweeteners, sweeteners, acidity correctors, flavorings.

[0048] In accordance with a preferred embodiment of the protein preparation according to the invention, the protein preparation comprises one or more preservatives, one or more rheology modifiers, one or more sweeteners, one or more sweeteners, one or more pH correctors and one or more flavors.

[0049] It is specified that in the context of the present treatment the expressions "one or more preservatives", "one or more rheology modifiers", "one or more sweeteners", "one or more sweeteners", "one or more pH correctors" and "one or more flavors" refer to the fact that the preparation may comprise a plurality of each of the aforementioned excipients, both belonging to the same chemical type, and belonging to different chemical types.

[0050] Specifically, the one or more preservatives comprise potassium sorbate.

[0051] Advantageously, the potassium sorbate is present in a concentration by weight, evaluated with respect to the total weight of the prepared preparation, between 0.05% and 2%.

[0052] Furthermore, the one or more rheology modifiers comprise xanthan gum.

[0053] Advantageously, xanthan gum is present in a weight concentration, evaluated with respect to the total weight of the preparation, between 0.05% and 2%.

[0054] Furthermore, the one or more sweeteners comprise acesulfame K present in a weight concentration, evaluated with respect to the total weight of the preparation, between 0.01% and 2%.

[0055] Furthermore, the one or more sweeteners comprise sucralose.

[0056] Sucralose is present in a weight concentration, evaluated with respect to the total weight of the preparation, between 0.001% and 1%.

[0057] Finally, the one or more pH correctors comprise phosphoric acid. Phosphoric acid is present in a weight concentration, evaluated with respect to the total weight of the preparation, between 0.5% and 2%.

[0058] Depending on the flavor that it is desired to attribute to the preparation according to the present invention, the latter comprises one or more flavorings.

[0059] In a second aspect, the present invention relates to the use of proteins isolated from substrates of plant origin in combination with one or more excipients for the preparation of food gels.

[0060] Specifically, the aforementioned proteins are present in a weight concentration, evaluated with respect to the total weight of the gel, greater than 10%.

[0061] Preferably, these proteins are isolated from peas.

[0062] It has been found in practice that the described invention achieves the proposed aims.

[0063] It is underlined that the particular expedient of providing for the use of pea proteins makes it possible to considerably increase the energizing power of the protein preparation according to the present invention.

[0064] Furthermore, the use of pea proteins makes it possible to perform a protective function against the prevention of the proliferation of pathogens in the gastro-intestinal system and their transfer to other systems of the human organism.

[0065] The composition and method of preparation of the hereby disclosed protein oral gel are intricately designed to achieve three critical health outcomes: minimizing inflammation, enhancing nutrient delivery through the blood-brain barrier (BBB), and ensuring optimal muscle delivery. These outcomes are achieved through the following mechanisms:

[0066] 1. Minimizing Inflammation:

[0067] The gel leverages the anti-inflammatory properties of plant-derived proteins, particularly those isolated from peas. Unlike animal proteins, plant proteins inherently contain lower levels of pro-inflammatory agents such as saturated fats and certain amino acid profiles that can exacerbate inflammation. Additionally, the production process is conducted at low temperatures, preserving the natural bioactivity of proteins and preventing the formation of advanced glycation end-products (AGEs), which are known to contribute to systemic inflammation. The absence of complex sugars further mitigates glycemic spikes, which can trigger inflammatory pathways. Pea proteins, as the primary source in this preparation, are inherently low in pro-inflammatory compounds such as arachidonic acid, commonly found in animal -based proteins. This reduces systemic inflammation and promotes a balanced immune response. Additionally, plant-based proteins are rich in naturally occurring antioxidants and polyphenols that neutralize free radicals and mitigate oxidative stress, further contributing to anti-inflammatory effects. By excluding complex sugars and employing sweeteners like sucralose and acesulfame K, the preparation avoids glycemic spikes. This minimizes insulin resistance and pancreatic stress, both of which are linked to systemic inflammation. The low-temperature manufacturing process prevents denaturation, maintaining the proteins' native structure and bioactivity. This reduces the likelihood of triggering inflammatory responses often associated with altered protein conformations. Enhancing Nutrient Delivery Through the Blood-Brain Barrier:

[0068] The formulation includes proteins and excipients carefully selected to support efficient transport of key nutrients across the BBB. Proteins with a high content of branched-chain amino acids (BCAAs) and peptides are included to facilitate brain uptake, supporting cognitive function and neuroprotection. The gel’s unique water-based matrix enhances solubility and bioavailability of these nutrients, allowing for seamless passage through the selective permeability of the BBB. This mechanism is critical for maintaining neurological health and combating neuroinflammation, which is linked to cognitive decline and neurological disorders. The amino acid profile of pea proteins, particularly the presence of essential amino acids like tryptophan and tyrosine, plays a pivotal role in supporting neurotransmitter synthesis. These amino acids serve as precursors for serotonin and dopamine, which can traverse the BBB and influence cognitive health. The gel's composition enhances solubility and transport of nutrients across the BBB. The inclusion of xanthan gum as a rheology modifier creates a stable, hydrophilic matrix that optimizes the bioavailability of critical nutrients. The exclusion of alcohols, polyalcohols, and other potentially disruptive agents ensures that the preparation does not compromise the integrity of the BBB or introduce harmful substances into the central nervous system. The preparation's nutrient profile is designed to align with active transport mechanisms in the BBB, leveraging specific amino acid transporters to efficiently deliver nutrients to the brain. Ensuring Optimal Muscle Delivery:

[0069] The gel's protein composition is specifically tailored for efficient muscle targeting, with a concentration range of 15-30% protein by weight, predominantly derived from peas. This concentration ensures a steady release of amino acids into the bloodstream, promoting muscle protein synthesis while minimizing the risk of unassimilated proteins contributing to metabolic strain. Additionally, the use of natural rheology modifiers like xanthan gum ensures a smooth gel consistency, facilitating rapid digestion and absorption. This property is particularly beneficial for athletes requiring immediate nutrient replenishment postexercise and for individuals with dysphagia who require easily consumable, nutrient-dense preparations.

[0070] 4. Synergy of Composition and Process:

[0071] The interplay between composition and preparation method is critical to achieving these health benefits. The reduced processing temperatures and exclusion of synthetic additives or alcohols ensure the preservation of protein integrity and bioactivity. Rheology modifiers such as xanthan gum and pH stabilizers like phosphoric acid not only enhance the gel’s stability but also support the controlled release of nutrients, aligning with the goal of sustained nutrient delivery.

[0072] 5. Comprehensive Nutritional and Therapeutic Benefits

[0073] By minimizing systemic and neuroinflammation, the preparation addresses both peripheral and central health concerns. This dual action is particularly beneficial for individuals with inflammatory conditions, neurological disorders, or cognitive decline. The formulation's focus on direct muscle and brain nutrient delivery ensures optimized use of ingested proteins and nutrients, reducing metabolic inefficiencies and promoting recovery and resilience in athletic and clinical populations. The gel's ease of swallowing and digestibility make it suitable for patients with dysphagia, while its nutrient profile supports overall well-being, addressing both caloric and therapeutic needs.

[0074] In addition to addressing inflammatory conditions, it is crucial to consider oncological diseases, where specific nutritional needs play a pivotal role. Therapeutic strategies must not only support general health but also combat sarcopenia, a condition characterized by the progressive loss of muscle mass and strength, commonly associated with aging and cancer. Sarcopenia significantly impacts the quality of life in elderly individuals and oncology patients, exacerbating frailty and reducing resilience to treatments. Malnutrition, often a direct consequence of cancer diagnosis and progression, stands as one of the leading causes of mortality in oncology patients, emphasizing the urgent need for innovative nutritional solutions that can provide targeted support to preserve muscle integrity, improve outcomes, and enhance overall well-being.

[0075] With reference to sweeteners, comprising for instance sucralose, the protein gel according to aspects of the present invention stands out by prioritizing natural options in addition or in alternative, such as erythritol and / or birch-derived xylitol, distinguishing it from conventional products that rely heavily on synthetic additives. The choice of natural sugars not only aligns with health-conscious principles but also enhances the product's appeal to consumers seeking cleaner, more sustainable ingredients. These natural sweeteners are incorporated in minimal percentages, serving primarily as functional carriers for active compounds, ensuring effective delivery without compromising metabolic balance or contributing to glycemic spikes.

[0076] In summary, the protein gel's design addresses the limitations of traditional formulations by offering a holistic approach that prioritizes bioavailability, anti-inflammatory properties, and precise nutrient targeting. The preparation method and carefully selected components create a versatile nutritional solution that supports overall health, enhances cognitive and muscular function, and mitigates inflammation. This makes the gel particularly suitable for athletes, patients with dysphagia, individuals seeking advanced nutritional interventions, oncology patients (adults and children), and older adults experiencing age-related muscle loss. In conclusion, the composition and method of preparation in this invention exemplify a scientifically grounded, nutritionally optimized approach to enhancing systemic and neurological health. By minimizing inflammation and facilitating effective nutrient delivery through the BBB, this preparation represents a significant advancement in both sports nutrition and therapeutic dietary formulations.

Claims

CLAIMS1. A protein oral preparation, in the form of a gel, characterized by proteins isolated from one or more substrates of plant origin and one or more excipients, wherein the proteins are present in a weight concentration of at least 10%, evaluated with respect to the total weight of the preparation.

2. Preparation according to claim 1, wherein said one or more substrates of plant origin are chosen from the list comprising: chickpeas, beans, broad beans, soybeans, peas, lentils, pine nuts, peanuts, almonds, pistachios, cashews, cashew nuts, walnuts, hazelnuts, quinoa, broccoli, artichokes, cabbage, spinach, peppers, asparagus, potatoes, chia, hemp, pumpkin, and sunflower.

3. The preparation of claim 1 or 2, wherein the proteins isolated from the substrates of plant origin are pea proteins.

4. Preparation according to one or more of the preceding claims, wherein the proteins are present in a weight concentration between 15% and 30%.

5. Preparation according to one or more of the preceding claims, wherein it comprises water present in a weight concentration, evaluated with respect to the total weight of the preparation, greater than 50%, preferably between 60% and 80%.

6. Preparation according to one or more of the preceding claims, wherein the one or more excipients are present in a weight concentration of 1.5% to 5%.

7. Preparation according to one or more of the preceding claims, wherein the one or more excipients are selected from the group consisting of preservatives, rheology modifiers, sweeteners, acidity correctors, and flavorings.

8. The preparation of claim 7, wherein the preservative comprises potassium sorbate.

9. The preparation of claim 8, wherein the potassium sorbate is present in a concentration of 0.05% to 2% by weight of the preparation.

10. The preparation of claim 7, wherein the rheology modifier comprises xanthan gum.

11. The preparation of claim 10, wherein the xanthan gum is present in a concentration of 0.05% to 2%.

12. The preparation of claim 7, wherein the sweetener comprises acesulfame K.

13. The preparation of claim 12, wherein the acesulfame K is present in a concentration of 0.01% to 2%.

14. The preparation of claim 7, wherein the sweetener further comprises sucralose.

15. The preparation of claim 14, wherein the sucralose is present in a concentration of 0.001% to 1%.

16. The preparation of claim 7, wherein the acidity corrector comprises phosphoric acid.

17. The preparation of claim 16, wherein the phosphoric acid is present in a concentration of 0.5% to 2%.

18. The preparation of claim 1, further comprising one or more flavorings tailored to desired sensory profiles.

19. The preparation of claim 1, wherein the preparation is free from components of animal origin.

20. Use of proteins isolated from substrates of plant origin in combination with one or more excipients for the preparation of food gels.

21. Use according to claim 20, wherein said proteins are present in a weight concentration, evaluated with respect to the total weight of the gel, greater than 10%.

22. Use according to any of claims 20 or 21, wherein said proteins are isolated from peas.

23. An intermediate product for use in preparing a protein gel, comprising proteins isolated from one or more substrates of plant origin, water, and a rheology modifier, wherein the proteins are present in a concentration greater than 10%.

24. The intermediate product of claim 23, further comprising potassium sorbate as a preservative and sucralose as a sweetener, wherein each is present in a weight concentration as defined in claims 9 and 15.

25. A method of preparing a protein oral preparation in the form of a gel, comprising:(a) isolating proteins from one or more substrates of plant origin;(b) mixing the isolated proteins with water and one or more excipients; and(c) forming the gel at a temperature that prevents protein denaturation.

26. The method of claim 25, wherein the step of isolating proteins involves extraction from substrates selected from the group of plant-based materials, wherein said one or more substrates of plant origin are chosen from the list comprising: chickpeas, beans, broad beans, soybeans, peas, lentils, pine nuts, peanuts, almonds, pistachios, cashews, walnuts, hazelnuts, quinoa, broccoli, artichokes, cabbage, spinach, peppers, asparagus, potatoes, chia, hemp, pumpkin, and sunflower.

27. The method of claim 25, wherein the gel is formed at a temperature below 70°C to retain protein bioactivity.

28. The method of claim 25, wherein the excipients are sequentially added to the protein-water mixture to optimize rheology and stability.

29. The method of claim 25, wherein potassium sorbate is incorporated during the final mixing step to ensure microbial stability.

30. The method of claim 25, further comprising adjusting the pH of the mixture using phosphoric acid to a range suitable for optimal gel stability.

31. The method of claim 25, wherein one or more flavorings are added to the mixture during or after the gel formation process.

32. The method of claim 25, wherein the proteins are isolated specifically from peas, and the gel is formed with a protein concentration of 15% to 30%.