PROCESS TO OBTAIN A NUTRACEUTICAL FORMULATION OF AMARANTH AND ITS USE IN TREATING HUMAN BEHAVIOR DISORDERS

Abstract

The present invention relates to a novel process to manufacture a nutraceutical formulation of amaranth, made from amaranth whole seeds. The nutraceutical formulation of amaranth obtained by the present invention has unique characteristics for addressing problems of great relevance in the priority field of public health, which significantly affects people in general, that is to say, the use in treating human behavioral disorders such as depression, stress, anxiety, and extreme cases like schizophrenia and bipolar disorder

Claims

1-30. (canceled)

31. A nutraceutical formulation of amaranth wherein Amaranthus hypochondriacus contains proteins with a high content of essential amino acids, unsaturated fatty acids, squalene, antioxidants, minerals and carbohydrates.

32. A nutraceutical formulation of amaranth in accordance with claim 31 in the form a soluble powder and/or capsules.

33. A nutraceutical formulation of amaranth in accordance with claim 31, wherein the formulation is a liquid.

34. A nutraceutical formulation of amaranth in accordance with claim 31, wherein the formulation is characterized by a solid presentation content of 43 to 47% of protein by weight of the total composition, 1-3% of lipids by weight of the total composition, 1-2% of salts by weight of the total composition, from 39 to 43% of carbohydrates by weight of the total composition, 3.0 to 3.50% of soluble fiber by weight of the total composition and from 3.5 to 4.0% moisture by weight of the total composition

35. A nutraceutical formulation of amaranth in accordance with claim 31, further characterized as having a good solubility in water at different temperatures from 4 to 60 C.

36. A process of preparing a nutraceutical product of Amaranth which includes selecting, clean seeds by sieves, washing the seeds with water, soaking the seeds with water free of microorganisms, washing the seeds soaked with water free of microorganisms, grinding the seeds, homogenizing the suspension of ground seeds, decanting or filtering the suspension, performing an alkaline extraction and isoelectric precipitation, wherein the extraction of the nutraceutical formulation is through a process of ultrafiltration and dialysis, subsequently adding an antioxidant, adding a stabilizer, adding a nutritional supplement, adding a colorant, adjusting the volume of the solution to a desired concentration of the nutraceutical formulation, homogenizing the suspension through agitation and drying the nutraceutical formulation.

37. The process in accordance with claim 36, also characterized by including an artificial or natural flavoring and coloring to the nutritional supplement.

38. The process in accordance with claim 36, also characterized by including a step of determining the amount of protein, amount of fat, and quantity of carbohydrates in the solid presentation.

39. The process in accordance with claim 36, also characterized by including a step of drying the liquid product to produce a solid product, in the form of soluble powder.

40. The process in accordance with claim 39, characterized by including a step of adding a flavoring to the solid product.

41. The process in accordance with claim 36, characterized by including a step wherein the seed selection is by visual inspection, in which, the seed must have a solid internal content and a uniform appearance of yellow, no Earth particles, nor seeds films and even small pieces of stem.

42. The process in accordance with claim 36, characterized by including a step of washing the seeds using water that has been treated by various filters that contain cellulose cartridges to remove dust particles and activated carbon cartridges to remove chlorine, and is finally treated with UV light to eliminate microorganisms.

43. The process in accordance with claim 36, characterized by including a step of soaking the seeds with treated water for 8 to 16 hours, at a temperature of 0 to 10 C.

44. The process in accordance with claim 42, characterized by including a step of washing the soaked seeds for 8 to 12 minutes in a stream of previously treated water, at a temperature between 0 and 10 C. and between 5 to 10 parts by volume per one part of seed weight.

45. The process in accordance with the claim 36, characterized by including a step of grinding the seeds to get a suspension by use of an industrial Blender, hammer mill or grinding media which have a system of blades.

46. The process in accordance with claim 36, characterized by a step of adding a flavor which is natural cinnamon in an amount which can range from 1.0 to 3.5 parts by weight per 100 parts by dry weight of the whole seed.

47. The process in accordance with claim 45, characterized by including a step of milling time which varies between 5 to 9 minutes.

48. The process in accordance with claim 45, characterized by including a step to set aside the suspension for a period of time between 6 and 15 minutes at a temperature of 10 C. to 30 C., and after that subjecting it to a stage of homogenization through agitation of the suspension for 10 to 20 minutes through a system of small-scale or industrial homogenization.

49. The process in accordance with the claim 45, characterized by including a step of filtration of the suspension through the use of a fabric of flannel, tissue usually carded, napping and slightly felting wool and the effect of gravity either using press industrial filtration equipment or using decanting processes filtration through semipermeable membranes, ultrafiltration membranes, dialysis scale plant pilot or industrial or other type of filtration of suspensions for industrial use.

50. The process in accordance with claim 36 characterized by including a step of adding of an antioxidant agent in the limits of 0.01 to 1.0 parts in dry seed weight, selected from a group consisting of ascorbic acid, salts of the ascorbic acid, erythorbic acid, potassium sulfite sodium sulfite dibasic, potassium sulfite dibasic, sodium hyposulfite and sodium citrate, potassium citrate and L-cysteine hydrochloride, preferably ascorbic acid.

51. The process in accordance with claim 36, characterized by including a step of using a stabilizing agent that is added to the suspension between 0.005 to 0.03 parts by weight per 100 parts by weight of dry seed, selected from a group consisting of agar-agar, acacia (Arabic gum), carrageenan, sodium alginate, Ghatti gum, Esterculia gum (Karaya gum), guar gum, calcium chloride and disodium phosphate, preferably carrageenan.

52. The process in accordance with claim 37, characterized because it including a step of selecting an artificial flavoring from the group that includes chocolate, vanilla, nuts, banana, coconut or mixtures thereof.

53. The process in accordance with claim 37, characterized by includes a step of adding the natural flavoring which is selected from the group consisting of guava, Apple, mango, peach, mamey, papaya, walnut, passion fruit, cherry, raspberry, BlackBerry, cranberry, grape or mixtures thereof.

54. The process in accordance with claim 37, characterized by including a step of adding a nutritional supplement which is selected from a group comprising vitamin C, vitamin D, vitamin E or B complex.

55. The process in accordance with claim 37, characterized by including a step to add coloring which is selected group comprising white 1, red 40 and yellow 5 or mixtures thereof.

56. The process in accordance with claim 36, characterized by including a step of selecting the concentration of the nutraceutical formulation to adjust the volume of the solution to 43 up to 47% protein by weight of the total composition, preferably 44.5% by weight of the total composition.

57. Use of a nutraceutical product from Amaranthus hypochondriacus, for the treatment of disorders of the human behavior such as depression, stress, anxiety, in its extreme cases such as, schizophrenia and bipolar disorder.

58. Use in accordance with claim 57, wherein early or preliminary stages of such human behavior disorders are selected from disorders such as irritable mood or under, loss of pleasure in usual and sexual activities, difficulty sleeping or sleep too much, change in appetite with gain or loss of weight, fatigue and lack of energy feelings of uselessness, lack of self-love and guilt, difficulty concentrating, slow or fast movements, feelings of sadness of pathologic type and abandonment, repetitive thoughts of death or suicide to its consummation and distractions frequent, crisis of anguish and anxiety, low working efficiency, delusions, hallucinations, affectivity flat, speech and abrupt changes in mood.

59. The use of the nutraceutical formulation of amaranth in accordance with claim 57, wherein it can be ingested by healthy individuals.

60. A nutraceutical delivery vehicle acceptable for a formulation of amaranth in capsule form.

61. The process in accordance with claim 40, characterized by including a step of adding a flavor which is natural cinnamon in an amount in a range from 1.0 to 3.5 parts by weight per 100 parts by dry weight of the whole seed.

62. The process in accordance with claim 48, characterized by including a step of filtration of the suspension through the use of a fabric of flannel, tissue usually carded, napping and slightly felting wool and the effect of gravity either using press industrial filtration equipment or using decanting processes filtration through semipermeable membranes, ultrafiltration membranes, dialysis scale plant pilot or industrial or other type of filtration of suspensions for industrial use.

63. The process in accordance with claim 37, characterized by includes a step of adding the natural flavoring which is selected from the group consisting of guava, Apple, mango, peach, mamey, papaya, walnut, passion fruit, cherry, raspberry, BlackBerry, cranberry, grape or mixtures thereof.

64. The process in accordance with claim 45, characterized by including a step of using a stabilizing agent that is added to the suspension between 0.005 to 0.03 parts by weight per 100 parts by weight of dry seed, selected from a group consisting of agar-agar, acacia (Arabic gum), carrageenan, sodium alginate, Ghatti gum, Esterculia gum (Karaya gum), guar gum, calcium chloride and disodium phosphate, preferably carrageenan.

Description

EXAMPLE 1

[0072] 50 to 250 grams of whole or full seeds are selected according to its inner solid content, by breaking the seed and inspecting them visually. Seeds are cleaned so as to remove black seeds, small pieces of stem, seed scales and dust particles. Seeds are washed with microorganism-free water. Seeds are soaked for various hours at a temperature between 4 and 36 C. using microorganism-free water. The soaked seeds are ground, in a hammer mill grinder until a suitable suspension is obtained. The suspension is filtered using a filter press in order to remove insoluble solids. The composition of insoluble solids is: fiber, protein that is non-soluble in aqueous solution, a portion of lipids and carbohydrates.

[0073] The protein is extracted using the alkali extraction and isoelectric methodology. The pH of the solution is increased to pH 11.0, using 0.1 N NaOH and continuous agitation for 2 hours for extraction, the suspension is filtered using industrial filter press equipment or another kind of slurry filter. In a second extraction, the solid material is resuspended in a 10% NaCl solution and continually agitated for 4 hours. The suspension is allowed to settle for one hour and then decanted. All solutions obtained in the first and second steps are mixed together and agitated for 1 hour in order to obtain an ideal mixture of nutrients. The liquid obtained undergoes an isoelectric precipitation process at pH of 7.5, using 0.1 N HCl. The obtained isolates contain the nutraceutical formulation nutrients of the present invention. The suspension obtained is allowed to settle for 2 to 4 hours, and then undergoes a drying process, which can be performed in, for example, but not limited to, a spray dryer in order to obtain a slightly yellowish powder.

[0074] The nutraceutical formulation composition is as follows: 43 to 47% protein; 1 to 3% lipids; 1 to 2% salts; 39-43% carbohydrates; 3.0-3.50 soluble fiber, and 3.5 to 4.0% moisture.

EXAMPLE 2

[0075] 50 to 250 grams of whole or full seeds are selected according to its inner solid content, by breaking the seed and inspecting them visually. Seeds are cleaned so as to remove black seeds, small pieces of stem, seed scales and dust particles. Seeds are washed with microorganism-free water. Seeds are soaked for various hours at room temperature using microorganism-free water. The soaked seeds are ground, in presence of cinnamon as a natural flavoring agent in a hammer mill grinder, and a stabilizer is added, until a suitable suspension is obtained. The suspension is filtered using a filter press in order to remove insoluble solids. The protein is extracted using the alkali extraction and isoelectric methodology. The pH of the solution is increased to pH 11.0, using 0.2 N NaOH and continuous agitation for 2 hours for extraction, the solution is decanted to obtain a first nutrient-rich solution for the nutraceutical formulation, the remaining solution and starch are filtered in a process using industrial filter press equipment or another type of industrial slurry filter. The liquid material thus obtained from the filtration step is incorporated to the liquid separated by decantation. In a second extraction, the solid matter is resuspended in a 20% NaCl solution and continually agitated for 4 hours. The suspension is allowed to settle for two hours and then decanted. Both solutions obtained in the first and second steps are mixed together and agitated for 1 hour in order to obtain an ideal mixture of nutrients. The pH of the liquid thus obtained is adjusted to pH 7.0 using 0.1 N HCl. The isolates prepared contain the nutraceutical formulation nutrients of the present invention. The suspension obtained is allowed to settle for 2 to 4 hours, and then undergoes a drying process, which can be performed in, for example, but not limited to, a laminar flow drying oven in order to obtain a slightly yellowish powder.

[0076] The nutraceutical formulation composition is as follows: 43 to 47% protein; 1 to 3% lipids; 1 to 2% salts; 39-43% carbohydrates; 3.0-3.50 soluble fiber, and 3.5 to 4.0% moisture.

EXAMPLE 3

[0077] 50 to 250 grams of whole or full seeds are selected according to its inner solid content, by breaking the seed and inspecting them visually. The black seeds, which correspond to wild amaranth, are not removed, but the small pieces of stem, seed scales and dust particles are removed. In this procedure wild seeds are used, which contain similar amounts of protein, lipids, carbohydrates and water as the cultivated seed. Seeds are washed with microorganism-free water. Seeds are soaked for a short period of time at room temperature using microorganism-free water. The soaked seeds are ground, in presence of cinnamon as a natural flavoring agent, in a knife mill grinder, and a stabilizer agent is added, until a suitable suspension is obtained. The suspension is filtered using a filter press or fabric filter fitted with a vacuum system in order to carry out the process in a fast and efficiently so as to remove insoluble solids.

[0078] The nutraceutical formulation is extracted using semipermeable membranes and pilot- or industrial-scale ultrafiltration equipment for the separation of components and, particularly, for the concentration and purification of proteins.

[0079] The isolates prepared contain the nutraceutical formulation nutrients of the present invention. The suspension obtained is allowed to settle for 2 to 4 hours and then undergoes a drying process, which can be performed in, for example, but not limited to, a spray dryer or a laminar flow drying oven in order to obtain a slightly yellowish powder.

[0080] The nutraceutical formulation composition is as follows: 43 to 47% protein; 1 to 3% lipids; 1 to 2% salts; 39-43% carbohydrates; 3.0-3.50 soluble fiber, and 3.5 to 4.0% moisture.

EXAMPLE 4

[0081] 50 to 250 grams of whole or full seeds are selected according to its inner solid content, by breaking the seed and inspecting them visually. Seeds are cleaned so as to remove black seeds, small pieces of stem, seed scales and dust particles. Seeds are washed with microorganism-free water. Seeds are soaked for a short period of time at room temperature using microorganism-free water. The soaked seeds are ground, in presence of cinnamon as a natural flavoring agent, in a hammer mill grinder and a stabilizer is added, until a suitable suspension is obtained. The suspension is filtered using a filter press or a filter equipped with a screening device made of stainless steel, in order to remove insoluble solids.

[0082] The protein is extracted using the dialysis or ultrafiltration process to concentrate and purify proteins. Said processes are based on the use of semipermeable membranes which allow small molecules to pass through them but not proteins or another macromolecules.

[0083] The nutraceutical formulation composition is as follows: 43 to 47% protein; 1 to 3% lipids; 1 to 2% salts; 39-43% carbohydrates; 3.0-3.50 soluble fiber, and 3.5 to 4.0% moisture.

EXAMPLE 5

[0084] In the efficacy measurement, a successful trial of antidepressants, anti-stress and anti-anxiety drugs requires that at least that 50% of the patients are responsive to the medication, which means that the depression, stress, anxiety, schizophrenia and bipolar symptoms have been reduced at least by 50%.

[0085] A group of 10 individuals with depression, stress and anxiety were administered six capsules (two capsule per meal, i.e. breakfast, lunch and dinner), each containing 400 g of the nutraceutical formulation, the test was successful because all 10 individuals showed a significant change in mood, by reducing by 90 to 95%, in less than half hour, the depression, stress, anxiety, schizophrenia and bipolar symptoms.

EXAMPLE 6

[0086] A group of 10 individuals with schizophrenia, bipolarity and extreme depression, were administered six capsules (two capsules per meal, i.e. breakfast, lunch and dinner), each containing 400 g of the nutraceutical formulation, the trial was successful because all 10 individuals showed a significant change in mood, by reducing by 90 to 95%, in less than half hour, the extreme symptoms of schizophrenia, bipolar disorder, depression, stress and anxiety.

[0087] The object of the invention is related to address problems of great relevance in the priority field of public health, which significantly affects people in general, that is to say, depression, stress, anxiety (DSA), schizophrenia and bipolar disorder.

[0088] The nutraceutical formulation composition is as follows: 43 to 47% protein; 1 to 3% lipids; 1 to 2% salts; 39-43% carbohydrates; 3.0-3.50 soluble fiber, and 3.5 to 4.0% moisture.

[0089] The above examples have been provided only for the purpose of exemplification and are not intended to limit the scope or contents of the invention. The invention is described in further detailed with reference to the following claims.