Nutritional composition for preventing and / or treating precocious puberty in children

Abstract

The present invention belongs to the technical field of medical products, and specifically provides a nutritional composition for preventing and / or treating precocious puberty in children. Proteins in the nutritional composition of the present invention are derived from high-quality proteins such as soy protein and whey protein, which are provided to help the growth and development of children. Among these, the soy protein, as a high-quality plant-based protein, can delay puberty and is negatively correlated with the percentage of body fat, and further inhibits precocious puberty by preventing obesity. In addition, dietary fibers from good sources such as fructo-oligosaccharides and galacto-oligosaccharides are added to the nutritional composition. The intake of high dietary fibers is associated with a later age at menarche, and more dietary fibers can delay the timing of pubertal development. By controlling the ratio of the soy protein to the dietary fibers at 3:1 to 5:1, the composition achieves efficacy in preventing precocious puberty in children.

Description

A nutritional composition for the prevention and / or treatment of precocious puberty in children Technical Field

[0001] This invention belongs to the field of pharmaceutical technology, specifically relating to a nutritional composition for the prevention and / or treatment of precocious puberty in children. Background Technology

[0002] Sexual maturation is the maturation process that occurs during puberty, including the acquisition of secondary sexual characteristics, rapid skeletal maturation, and accelerated growth. Precocious puberty is defined as puberty occurring two standard deviations earlier than the general population, meaning that girls develop breasts or develop testes before age 8, and boys develop testes or enlarge their testes before age 9. Precocious puberty is generally defined as the onset of puberty in girls before age 8 and in boys before age 9. For children with delayed puberty, it may be necessary to develop puberty-specific criteria.

[0003] Precocious puberty is classified into gonadotropin-dependent (central) or independent of gonadal steroid production (peripheral) based on its pathogenesis and clinical manifestations. Most girls experience central precocious puberty, while boys are more prone to peripheral precocious puberty. Incomplete precocious puberty is common in girls, limited to isolated premature breast development (IPT), isolated premature pubic hair growth, or isolated vaginal bleeding (local causes). The main harms of precocious puberty are affecting a child's final height and causing negative psychological impacts such as low self-esteem, anxiety, and depression, and even contributing to an increase in juvenile delinquency rates.

[0004] The exact causes of precocious puberty are not yet fully understood, but its occurrence may be related to various factors, such as poor dietary habits, disharmonious family relationships, exposure to environmental endocrine disruptors, and gene mutations. Treatment interventions include drug therapy and lifestyle interventions.

[0005] Dietary nutrition is closely related to precocious puberty in children. Protein, carbohydrates, fats, dietary fiber, soybeans, micronutrients such as iron, zinc, and calcium, fruits and vegetables, and nutritional supplements are all closely related to the onset of puberty. Early intervention through nutritional methods to regulate metabolic disorders in children with precocious puberty can help them return to a normal growth and development track. However, there are currently no research reports on nutritional compositions that can improve precocious puberty in children. Summary of the Invention

[0006] To address the above problems, the present invention provides a nutritional composition for preventing and / or treating precocious puberty in children, characterized in that the nutritional composition contains soybean protein and dietary fiber in a mass ratio of 3 to 5:1.

[0007] Furthermore, the nutritional composition comprises the following components:

[0008] Protein: 220-260 parts; Fat: 100-160 parts; Carbohydrates: 600-800 parts; Dietary Fiber: 30-50 parts; Complex Trace Minerals: 0.68-0.98 parts; Complex Macro Minerals: 46-83 parts; Complex Vitamins: 2.6-3.1 parts; DHA: 2.45-4.7 parts; Arachidonic Acid: 0.07-0.09 parts.

[0009] The protein-like substance is composed of 70-90 parts whey protein and 150-160 parts soy protein.

[0010] Furthermore, the fatty substance is a vegetable oil microcapsule powder made from 30-50 parts of medium-chain triglycerides, 55-85 parts of soybean oil, 15-25 parts of low-erucic acid rapeseed oil, and the remainder being an edible carrier.

[0011] The edible carrier is composed of 10-51 parts of maltodextrin, 2-17 parts of sodium caseinate, 0.2-2.2 parts of mono- and diglycerides of fatty acids, and 0.01-1.8 parts of vitamin E.

[0012] Furthermore, the carbohydrate consists of 300-580 parts maltodextrin and 220-300 parts solid corn syrup.

[0013] Furthermore, the dietary fiber is composed of 10-20 parts of galactooligosaccharides and 20-30 parts of fructooligosaccharides.

[0014] Furthermore, the composite trace minerals are composed of 0.009-0.02 parts copper sulfate, 0.60-0.74 parts ferric pyrophosphate, 0.0035-0.006 parts manganese sulfate, 0.000095-0.000097 parts sodium selenite, 0.06-0.26 parts zinc citrate, 0.0008-0.0018 parts potassium iodide, and the balance being an edible carrier.

[0015] Furthermore, the composite macromineral is composed of 32.7-46.1 parts tricalcium phosphate, 1.2-3.6 parts calcium carbonate, 3.1-5.1 parts magnesium carbonate, 4.5-12.2 parts potassium chloride, 3.1-9.2 parts dipotassium hydrogen phosphate, 1.4-6.8 parts sodium citrate, and the balance being an edible carrier.

[0016] Further, the complex vitamin is composed of 0.0045-0.015 parts retinyl palmitate, 0.00004-0.00008 parts vitamin D3, 0.2-0.5 parts dl-α-tocopherol acetate, 0.00033-0.00085 parts vitamin K1, 0.008-0.025 parts thiamine hydrochloride, 0.006-0.024 parts vitamin B2, 0.05-0.1 parts nicotinamide, 0.04-0.1 parts D-calcium pantothenate, 0.008-0.02 parts pyridoxine hydrochloride, 0.0001-0.0003 parts D-biotin, 0.001-0.004 parts folic acid, 0.000025-0.000045 parts cyanocobalamin, 2.09-2.31 parts L-sodium ascorbate, and the balance being an edible carrier.

[0017] Furthermore, the edible carrier is maltodextrin.

[0018] The present invention also provides the use of the aforementioned nutritional composition in the preparation of a medicament for the prevention and / or treatment of precocious puberty in children.

[0019] The beneficial effects of this invention are:

[0020] (1) The protein in the nutritional composition of this invention is derived from soy protein, whey protein, etc., which provide high-quality protein that helps children's growth and development. Soy protein, as a high-quality plant protein, can delay puberty and is negatively correlated with body fat percentage, thus further inhibiting precocious puberty by preventing obesity. At the same time, the nutritional composition contains dietary fiber from good sources such as fructooligosaccharides and galactooligosaccharides. High dietary fiber intake is related to late menarche age, and more dietary fiber can delay puberty. Animal experiments of this invention have also confirmed that omitting soy protein and dietary fiber from the edible nutritional composition cannot prevent or treat precocious puberty. Adding any proportion of soy protein and dietary fiber will also fail to achieve the purpose of preventing or treating precocious puberty. Only by controlling the ratio of soy protein to dietary fiber in the nutritional composition at 3:1-5:1 can the composition have a significant effect in intervening in precocious puberty in children.

[0021] (2) The nutritional composition of the present invention is reasonably configured and rich in high-quality animal and plant proteins, fatty acids, various vitamins, minerals and water-soluble dietary fiber. It is easy to digest and absorb and can be used as a single or partial source of nutrition to supplement nutrition and achieve the goal of balanced nutrition for children.

[0022] (3) The nutritional composition of the present invention contains DHA and arachidonic acid, which help promote healthy brain development in children and avoid indirectly affecting the occurrence of precocious puberty.

[0023] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0024] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Detailed Implementation

[0025] The raw materials and equipment used in the specific embodiments of the present invention can all be purchased commercially. The low erucic acid rapeseed oil is rapeseed oil with an erucic acid content of no more than 3% of the fatty acid composition. The oligomaltose is an oligosaccharide composed of 3 to 10 glucose molecules linked by α-1,4 glycosidic bonds.

[0026] Example 1: The nutritional composition of the present invention (the ratio of soybean protein to dietary fiber in the formula is 3:1)

[0027] Formula: 600 parts carbohydrates, 220 parts protein, 100 parts fat, 50 parts dietary fiber, 2.6 parts compound vitamins, 0.68 parts compound trace minerals, 46 parts compound macro minerals, 2.45 parts DHA, and 0.07 parts arachidonic acid;

[0028] The carbohydrates consist of 300 parts maltodextrin and 300 parts solid corn syrup.

[0029] The protein-containing substance consists of 70 parts whey protein and 150 parts soy protein;

[0030] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through a microencapsulation process. The medium-chain triglycerides are 30 parts, soybean oil is 55 parts, low-erucic acid rapeseed oil is 15 parts, and the remainder is an edible carrier (which is a mixture of 15 parts oligomaltose, 6 parts sodium caseinate, 1.1 parts mono- and diglycerides of fatty acids, and 0.1 parts vitamin E).

[0031] Dietary fiber consists of 20 parts galactooligosaccharides and 30 parts fructooligosaccharides;

[0032] The compound vitamin consists of 0.0045 parts retinyl palmitate, 0.00004 parts vitamin D3, 0.2 parts dl-α-tocopherol acetate, 0.00033 parts vitamin K1, 0.008 parts thiamine hydrochloride, 0.006 parts vitamin B2, 0.05 parts nicotinamide, 0.04 parts D-calcium pantothenate, 0.008 parts pyridoxine hydrochloride, 0.0001 parts D-biotin, 0.001 parts folic acid, 0.000025 parts cyanocobalamin, and 2.282005 parts L-sodium ascorbate, with the remainder being maltodextrin, a compound vitamin carrier.

[0033] The compound trace minerals consist of 0.009 parts copper sulfate, 0.606605 parts ferric pyrophosphate, 0.0035 parts manganese sulfate, 0.000095 parts sodium selenite, 0.06 parts zinc citrate, and 0.0008 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0034] The compound macrominerals consist of 32.7 parts of dicalcium phosphate, 1.2 parts of calcium carbonate, 3.1 parts of magnesium carbonate, 4.5 parts of potassium chloride, 3.1 parts of dipotassium hydrogen phosphate, and 1.4 parts of sodium citrate, with the remainder being maltodextrin, a compound macromineral carrier.

[0035] Preparation method:

[0036] (1) Accurately weigh the raw materials according to the formula requirements;

[0037] (2) Transfer DHA, arachidonic acid, compound trace minerals and compound vitamins to a three-dimensional motion mixer, mix at 30 rpm for 20 minutes to obtain mixture 1;

[0038] (3) Transfer the compound macro minerals, galactooligosaccharides and fructooligosaccharides to a three-dimensional motion mixer and mix them together with premix 1 at 30 rpm for 20 minutes to obtain mixture 2;

[0039] (3) Transfer whey protein, vegetable oil microcapsule powder and soy protein to a three-dimensional motion mixer and mix them together with premix 2 at 30 rpm for 30 minutes to obtain mixture 3;

[0040] (4) Transfer the maltodextrin and solid corn syrup to a three-dimensional motion mixer and mix them together with the premix 3 at 30 rpm for 60 minutes to obtain the total mixture.

[0041] (5) The mixed products are dispensed and packaged under aseptic conditions.

[0042] Example 2: The nutritional composition of the present invention (the ratio of soy protein to dietary fiber in the formula is 4:1)

[0043] Formula: 800 parts carbohydrates, 260 parts protein, 160 parts fat, 40 parts dietary fiber, 3.1 parts compound vitamins, 0.98 parts compound trace minerals, 83 parts compound macro minerals, 4.7 parts DHA, and 0.09 parts arachidonic acid;

[0044] The carbohydrates consist of 580 parts maltodextrin and 220 parts solid corn syrup;

[0045] The protein-containing substance consists of 100 parts whey protein and 160 parts soy protein;

[0046] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through microencapsulation and other processes. The medium-chain triglycerides are 50 parts, soybean oil is 85 parts, low-erucic acid rapeseed oil is 25 parts, and the remainder is an edible carrier (which is a mixture of 32 parts oligomaltose, 8 parts sodium caseinate, 0.8 parts mono- and diglycerides of fatty acids, and 1.2 parts vitamin E).

[0047] Dietary fiber consists of 15 parts of galactooligosaccharides and 25 parts of fructooligosaccharides.

[0048] The compound vitamin consists of 0.015 parts retinyl palmitate, 0.00008 parts vitamin D3, 0.5 parts dl-α-tocopherol acetate, 0.00085 parts vitamin K1, 0.025 parts thiamine hydrochloride, 0.024 parts vitamin B2, 0.1 parts nicotinamide, 0.1 parts D-calcium pantothenate, 0.02 parts pyridoxine hydrochloride, 0.0003 parts D-biotin, 0.004 parts folic acid, 0.000045 parts cyanocobalamin, and 2.310725 parts L-sodium ascorbate, with the remainder being maltodextrin, a compound vitamin carrier.

[0049] The compound trace minerals consist of 0.02 parts copper sulfate, 0.692103 parts ferric pyrophosphate, 0.006 parts manganese sulfate, 0.000097 parts sodium selenite, 0.26 parts zinc citrate, and 0.0018 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0050] The compound macrominerals consist of 46.1 parts dicalcium phosphate, 3.6 parts calcium carbonate, 5.1 parts magnesium carbonate, 12.2 parts potassium chloride, 9.2 parts dipotassium hydrogen phosphate, and 6.8 parts sodium citrate. The remainder is composed of maltodextrin, a compound macromineral carrier.

[0051] Preparation method: Same as in Example 1

[0052] Example 3: The nutritional composition of the present invention (the ratio of soybean protein to dietary fiber in the formula is 3:1).

[0053] Formula: 700 parts carbohydrates, 249 parts protein, 130 parts fat, 30 parts dietary fiber, 2.7 parts compound vitamins, 0.87 parts compound trace minerals, 65 parts compound macro minerals, 3.57 parts DHA, and 0.08 parts arachidonic acid;

[0054] The carbohydrates consist of 400 parts maltodextrin and 300 parts solid corn syrup;

[0055] The protein-containing substance consists of 159 parts whey protein and 90 parts soy protein;

[0056] The fatty substances are vegetable oil microcapsule powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through microencapsulation and other processes. The medium-chain triglycerides are 40 parts, soybean oil is 70 parts, low-erucic acid rapeseed oil is 20 parts, and the remainder is an edible carrier (which is a mixture of 17 parts oligomaltose, 6 parts sodium caseinate, 0.6 parts mono- and diglycerides of fatty acids, and 0.07 parts vitamin E).

[0057] Dietary fiber consists of 10 parts of galactooligosaccharides and 20 parts of fructooligosaccharides.

[0058] The compound vitamin consists of 0.0075 parts retinyl palmitate, 0.00006 parts vitamin D3, 0.4 parts dl-α-tocopherol acetate, 0.00053 parts vitamin K1, 0.015 parts thiamine hydrochloride, 0.014 parts vitamin B2, 0.08 parts nicotinamide, 0.07 parts D-calcium pantothenate, 0.01 parts pyridoxine hydrochloride, 0.0002 parts D-biotin, 0.003 parts folic acid, 0.000035 parts cyanocobalamin, and 2.099675 parts L-sodium ascorbate. The remainder is composed of maltodextrin, a compound vitamin carrier.

[0059] The compound trace minerals consist of 0.01 parts copper sulfate, 0.734204 parts ferric pyrophosphate, 0.0045 parts manganese sulfate, 0.000096 parts sodium selenite, 0.12 parts zinc citrate, and 0.0012 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0060] The compound macromineral composition consists of 39.3 parts dicalcium phosphate, 1.6 parts calcium carbonate, 4.1 parts magnesium carbonate, 8.4 parts potassium chloride, 7.3 parts dipotassium hydrogen phosphate, and 4.3 parts sodium citrate. The remainder is composed of maltodextrin, a compound macromineral carrier.

[0061] Preparation method: Same as in Example 1.

[0062] Example 4: The nutritional composition of the present invention (the ratio of soy protein to dietary fiber in the formula is 4:1)

[0063] Formula: 700 parts carbohydrates, 249 parts protein, 130 parts fat, 30 parts dietary fiber, 2.7 parts compound vitamins, 0.87 parts compound trace minerals, 65 parts compound macro minerals, 3.57 parts DHA, and 0.08 parts arachidonic acid;

[0064] The carbohydrates consist of 400 parts maltodextrin and 300 parts solid corn syrup;

[0065] The protein-containing substance consists of 129 parts whey protein and 120 parts soy protein;

[0066] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through microencapsulation and other processes. The powders contain 40 parts medium-chain triglycerides, 70 parts soybean oil, and 20 parts low-erucic acid rapeseed oil, with the remainder being an edible carrier (composed of 17 parts maltodextrin, 6 parts sodium caseinate, 0.6 parts mono- and diglyceride fatty acid esters, and 0.07 parts vitamin E). The dietary fiber consists of 10 parts galactooligosaccharides and 20 parts fructooligosaccharides.

[0067] The compound vitamin consists of 0.0075 parts retinyl palmitate, 0.00006 parts vitamin D3, 0.4 parts dl-α-tocopherol acetate, 0.00053 parts vitamin K1, 0.015 parts thiamine hydrochloride, 0.014 parts vitamin B2, 0.08 parts nicotinamide, 0.07 parts D-calcium pantothenate, 0.01 parts pyridoxine hydrochloride, 0.0002 parts D-biotin, 0.003 parts folic acid, 0.000035 parts cyanocobalamin, and 2.099675 parts L-sodium ascorbate. The remainder is composed of maltodextrin, a compound vitamin carrier.

[0068] The compound trace minerals consist of 0.01 parts copper sulfate, 0.734204 parts ferric pyrophosphate, 0.0045 parts manganese sulfate, 0.000096 parts sodium selenite, 0.12 parts zinc citrate, and 0.0012 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0069] The compound macromineral composition consists of 39.3 parts dicalcium phosphate, 1.6 parts calcium carbonate, 4.1 parts magnesium carbonate, 8.4 parts potassium chloride, 7.3 parts dipotassium hydrogen phosphate, and 4.3 parts sodium citrate. The remainder is composed of maltodextrin, a compound macromineral carrier.

[0070] Preparation method: Same as in Example 1.

[0071] Example 5: The nutritional composition of the present invention (the ratio of soybean protein to dietary fiber in the formula is 5:1).

[0072] Formula: 700 parts carbohydrates, 249 parts protein, 130 parts fat, 30 parts dietary fiber, 2.7 parts compound vitamins, 0.87 parts compound trace minerals, 65 parts compound macro minerals, 3.57 parts DHA, and 0.08 parts arachidonic acid;

[0073] The carbohydrates consist of 400 parts maltodextrin and 300 parts solid corn syrup;

[0074] The protein-containing substance consists of 99 parts whey protein and 150 parts soy protein;

[0075] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through microencapsulation and other processes. The powders contain 40 parts medium-chain triglycerides, 70 parts soybean oil, and 20 parts low-erucic acid rapeseed oil, with the remainder being an edible carrier (composed of 17 parts maltodextrin, 6 parts sodium caseinate, 0.6 parts mono- and diglyceride fatty acid esters, and 0.07 parts vitamin E). The dietary fiber consists of 10 parts galactooligosaccharides and 20 parts fructooligosaccharides.

[0076] The compound vitamin consists of 0.0075 parts retinyl palmitate, 0.00006 parts vitamin D3, 0.4 parts dl-α-tocopherol acetate, 0.00053 parts vitamin K1, 0.015 parts thiamine hydrochloride, 0.014 parts vitamin B2, 0.08 parts nicotinamide, 0.07 parts D-calcium pantothenate, 0.01 parts pyridoxine hydrochloride, 0.0002 parts D-biotin, 0.003 parts folic acid, 0.000035 parts cyanocobalamin, and 2.099675 parts L-sodium ascorbate. The remainder is composed of maltodextrin, a compound vitamin carrier.

[0077] The compound trace minerals consist of 0.01 parts copper sulfate, 0.734204 parts ferric pyrophosphate, 0.0045 parts manganese sulfate, 0.000096 parts sodium selenite, 0.12 parts zinc citrate, and 0.0012 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0078] The compound macromineral composition consists of 39.3 parts dicalcium phosphate, 1.6 parts calcium carbonate, 4.1 parts magnesium carbonate, 8.4 parts potassium chloride, 7.3 parts dipotassium hydrogen phosphate, and 4.3 parts sodium citrate. The remainder is composed of maltodextrin, a compound macromineral carrier.

[0079] Preparation method: Same as in Example 1

[0080] Comparative Example 1: Nutritional composition (the ratio of soy protein to dietary fiber in the formula is 2:1)

[0081] Formula: 700 parts carbohydrates, 249 parts protein, 130 parts fat, 30 parts dietary fiber, 2.7 parts compound vitamins, 0.87 parts compound trace minerals, 65 parts compound macro minerals, 3.57 parts DHA, and 0.08 parts arachidonic acid;

[0082] The carbohydrates consist of 400 parts maltodextrin and 300 parts solid corn syrup.

[0083] The protein-containing substance consists of 189 parts whey protein and 60 parts soy protein.

[0084] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through microencapsulation and other processes. The powder consists of 40 parts medium-chain triglycerides, 70 parts soybean oil, 20 parts low-erucic acid rapeseed oil, and the remainder is an edible carrier (composed of 17 parts maltodextrin, 6 parts sodium caseinate, 0.6 parts mono- and diglycerides of fatty acids, and 0.07 parts vitamin E). The dietary fiber consists of 10 parts galactooligosaccharides and 20 parts fructooligosaccharides.

[0085] The compound vitamin consists of 0.0075 parts retinyl palmitate, 0.00006 parts vitamin D3, 0.4 parts dl-α-tocopherol acetate, 0.00053 parts vitamin K1, 0.015 parts thiamine hydrochloride, 0.014 parts vitamin B2, 0.08 parts nicotinamide, 0.07 parts D-calcium pantothenate, 0.01 parts pyridoxine hydrochloride, 0.0002 parts D-biotin, 0.003 parts folic acid, 0.000035 parts cyanocobalamin, and 2.099675 parts L-sodium ascorbate. The remainder is composed of maltodextrin, a compound vitamin carrier.

[0086] The compound trace minerals consist of 0.01 parts copper sulfate, 0.734204 parts ferric pyrophosphate, 0.0045 parts manganese sulfate, 0.000096 parts sodium selenite, 0.12 parts zinc citrate, and 0.0012 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0087] The compound macromineral composition consists of 39.3 parts dicalcium phosphate, 1.6 parts calcium carbonate, 4.1 parts magnesium carbonate, 8.4 parts potassium chloride, 7.3 parts dipotassium hydrogen phosphate, and 4.3 parts sodium citrate. The remainder is composed of maltodextrin, a compound macromineral carrier.

[0088] Preparation method: Same as in Example 1

[0089] Comparative Example 2: Nutritional composition (the ratio of soy protein to dietary fiber in the formula is 6:1)

[0090] Formula: 700 parts carbohydrates, 249 parts protein, 130 parts fat, 30 parts dietary fiber, 2.7 parts compound vitamins, 0.87 parts compound trace minerals, 65 parts compound macro minerals, 3.57 parts DHA, and 0.08 parts arachidonic acid;

[0091] The carbohydrates consist of 400 parts maltodextrin and 300 parts solid corn syrup;

[0092] The protein-containing substance consists of 69 parts whey protein and 180 parts soy protein;

[0093] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and edible carriers through microencapsulation and other processes. The powders contain 40 parts medium-chain triglycerides, 70 parts soybean oil, and 20 parts low-erucic acid rapeseed oil, with the remainder being an edible carrier (composed of 17 parts maltodextrin, 6 parts sodium caseinate, 0.6 parts mono- and diglyceride fatty acid esters, and 0.07 parts vitamin E). The dietary fiber consists of 10 parts galactooligosaccharides and 20 parts fructooligosaccharides.

[0094] The compound vitamin consists of 0.0075 parts retinyl palmitate, 0.00006 parts vitamin D3, 0.4 parts dl-α-tocopherol acetate, 0.00053 parts vitamin K1, 0.015 parts thiamine hydrochloride, 0.014 parts vitamin B2, 0.08 parts nicotinamide, 0.07 parts D-calcium pantothenate, 0.01 parts pyridoxine hydrochloride, 0.0002 parts D-biotin, 0.003 parts folic acid, 0.000035 parts cyanocobalamin, and 2.099675 parts L-sodium ascorbate, with the remainder being maltodextrin, a compound vitamin carrier.

[0095] The compound trace minerals consist of 0.01 parts copper sulfate, 0.734204 parts ferric pyrophosphate, 0.0045 parts manganese sulfate, 0.000096 parts sodium selenite, 0.12 parts zinc citrate, and 0.0012 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0096] The compound macrominerals consist of 39.3 parts of dicalcium phosphate, 1.6 parts of calcium carbonate, 4.1 parts of magnesium carbonate, 8.4 parts of potassium chloride, 7.3 parts of dipotassium hydrogen phosphate, and 4.3 parts of sodium citrate, with the remainder being maltodextrin, a compound macromineral carrier.

[0097] Preparation method: Same as in Example 1

[0098] Comparative Example 3: Nutritional composition (lacking soy protein and dietary fiber in its formulation)

[0099] Formula: 700 parts carbohydrates, 249 parts protein, 130 parts fat, 0 parts dietary fiber, 2.7 parts compound vitamins, 0.87 parts compound trace minerals, 65 parts compound macro minerals, 3.57 parts DHA, and 0.08 parts arachidonic acid;

[0100] The carbohydrates consist of 400 parts maltodextrin and 300 parts solid corn syrup;

[0101] The protein-containing substances consisted of 249 parts of whey protein;

[0102] The fatty substances are vegetable oil microencapsulated powders made from low-erucic acid rapeseed oil, soybean oil, medium-chain triglycerides, and an edible carrier through microencapsulation and other processes. The powder contains 40 parts medium-chain triglycerides, 70 parts soybean oil, and 20 parts low-erucic acid rapeseed oil. The remainder is an edible carrier (composed of 17 parts maltodextrin, 6 parts sodium caseinate, 0.6 parts mono- and diglycerides of fatty acids, and 0.07 parts vitamin E). The compound vitamins consist of 0.0075 parts retinyl palmitate, 0.00006 parts vitamin D3, 0.4 parts dl-α-tocopherol acetate, 0.00053 parts vitamin K1, 0.015 parts thiamine hydrochloride, and vitamin B2. 0.014 parts, 0.08 parts, D-calcium pantothenate, 0.07 parts, pyridoxine hydrochloride, 0.01 parts, D-biotin, 0.0002 parts, folic acid, 0.003 parts, cyanocobalamin, 0.000035 parts, L-sodium ascorbate, 2.099675 parts, with the remainder being maltodextrin, a complex vitamin carrier.

[0103] The compound trace minerals consist of 0.01 parts copper sulfate, 0.734204 parts ferric pyrophosphate, 0.0045 parts manganese sulfate, 0.000096 parts sodium selenite, 0.12 parts zinc citrate, and 0.0012 parts potassium iodide, with the remainder being maltodextrin as a compound trace mineral carrier.

[0104] The compound macrominerals consist of 39.3 parts of dicalcium phosphate, 1.6 parts of calcium carbonate, 4.1 parts of magnesium carbonate, 8.4 parts of potassium chloride, 7.3 parts of dipotassium hydrogen phosphate, and 4.3 parts of sodium citrate, with the remainder being maltodextrin, a compound macromineral carrier.

[0105] Preparation method: Same as in Example 1

[0106] The following experimental examples illustrate the beneficial effects of the present invention.

[0107] <Experimental Example 1>

[0108] 1 animal

[0109] One hundred specific pathogen-free (SPF) 15-day-old female SD rats were housed in a clean, naturally lit room with controlled temperature (25.0±5℃) and relative humidity (50%±5%) with free access to food and water.

[0110] 2 methods

[0111] 2.1 Animal grouping and administration

[0112] One hundred female rats were acclimatized for one week and then randomly divided into 10 groups: normal group, model group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. Except for the normal group, the other nine groups received a single subcutaneous injection of danazol 300 μg to establish a precocious puberty model. Drug administration was initiated 15 days after model establishment. Example 1, Example 2, Example 3, Example 4, Example 5, Comparative Example 1, Comparative Example 2, and Comparative Example 3 groups were administered the prepared powder (at a rate of 9.0 g / (kg*d)) by gavage; the normal group and model group were administered an equal volume of physiological saline by gavage. The vulvar opening time of the rats was recorded, and drug administration was discontinued after vulvar opening in each group.

[0113] The following is a list of the oral administration formulas for each treatment group.

[0114] 2.2 Detection Indicators and Methods

[0115] 2.2.1 Uterine index and ovarian index

[0116] After the rats were sacrificed, the uterus and ovaries were removed and weighed, and the uterine index and ovarian index were calculated. Uterine index = uterine mass (g) / rat mass (g); Ovarian index = ovarian mass (g) / rat mass (g).

[0117] 2.2.2 Serum sex hormone levels in rats

[0118] Peripheral blood was collected from rats, centrifuged, and the supernatant was stored at -20°C. The levels of LH (luteinizing hormone), FSH (follicle-stimulating hormone), and E2 (estradiol) in peripheral blood were detected using ELISA, strictly following the kit instructions.

[0119] 3 Results

[0120] Table 2 Comparison of vulvar opening time in different groups of rats Note: * indicates a comparison with the normal group, p<0.05; # This indicates a p < 0.05 comparison with the model group.

[0121] As shown in Table 2, compared with the normal group, the vaginal opening time of the model group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group was significantly earlier, and the difference was statistically significant (p<0.05). Compared with the model group, the vaginal opening time of Example 1 group, Example 2 group, Example 3 group, Example 4 group, and Example 5 group was significantly delayed, and the difference was statistically significant (p<0.05). Compared with the model group, the vaginal opening time of Comparative Example 1 group and Comparative Example 2 group was slightly delayed, but the difference was not statistically significant (p<0.05). Compared with the model group, the vaginal opening time of Comparative Example 3 group did not change significantly, and the difference was not statistically significant (p<0.05).

[0122] Table 3 Comparison of uterine and ovarian indices in rats of different groups Note: * indicates a comparison with the normal group, p<0.05; # This indicates that compared with the model group, p < 0.05.

[0123] As shown in Table 3, compared with the normal group, the uterine and ovarian indices of the model group, comparative example 1, comparative example 2, and comparative example 3 were significantly increased (p<0.05). Compared with the normal group, the uterine and ovarian indices of example 1, example 2, example 3, example 4, and example 5 were slightly increased (p>0.05). Compared with the model group, the uterine and ovarian indices of example 1, example 2, example 3, example 4, and example 5 were significantly decreased (p<0.05). Compared with the model group, the uterine and ovarian indices of comparative example 1 and comparative example 2 were slightly decreased (p>0.05). Compared with the model group, the uterine and ovarian indices of comparative example 3 were slightly decreased (p>0.05).

[0124] Table 4 Comparison of LH, FSH, and E2 levels in rats of different groups Note: * indicates a comparison with the normal group, p<0.05; # This indicates that compared with the model group, p < 0.05.

[0125] As shown in Table 4, compared with the normal group, the levels of LH, FSH, and E2 in the model group, comparative example 1, comparative example 2, and comparative example 3 were significantly increased, and the differences were statistically significant (p<0.05). Compared with the normal group, the levels of E2, LH, and FSH in example 1, example 2, example 3, example 4, and example 5 were increased. Except for the E2 level in example 1, which showed a statistically significant difference (p<0.05), the other differences were not statistically significant (p>0.05). Compared with the model group, the levels of LH, FSH, and E2 in Example 1, Example 2, Example 3, Example 4, and Example 5 were significantly lower, and the differences were statistically significant (p<0.05). Compared with the model group, the levels of LH, FSH, and E2 in Comparative Example 1 and Comparative Example 2 were slightly lower, but the differences were not statistically significant (p>0.05). Compared with the model group, the levels of LH, FSH, and E2 in Comparative Example 3 were slightly lower, but the differences were not statistically significant (p>0.05).

[0126] The experimental results showed that compared with the normal group, the vulvar opening time of rat pups in the model group was significantly earlier, and the uterine and ovarian indices were significantly increased, as were the serum levels of hormones E2, LH, and FSH. Compared with the model group, the vulvar opening time of groups 1, 2, 3, 4, and 5 was significantly delayed, and the uterine and ovarian indices and serum levels of hormones E2, LH, and FSH were significantly decreased. Compared with the model group, the comparative groups 1-3 showed no significant improvement in vulvar opening time, uterine and ovarian indices, or serum levels of hormones E2, LH, and FSH.

[0127] The results showed that the groups of Examples 1, 2, 3, 4, and 5, which had a soybean protein to dietary fiber ratio of 3:1 to 5:1, had a good therapeutic effect on the danazol-induced precocious puberty model. The groups of Comparative Examples 1 and 2, which had a soybean protein to dietary fiber ratio outside the range of 3:1 to 5:1, and Comparative Example 3, which lacked both soybean protein and dietary fiber, had no significant effect on the danazol-induced precocious puberty model.

[0128] In summary, the experimental results show that the nutritional composition of the present invention has a good therapeutic effect on precocious puberty and can be used to prepare medicines for the prevention and / or treatment of precocious puberty in children.

Claims

1. A nutritional composition for the prevention and / or treatment of precocious puberty in children, characterized in that: The nutritional composition comprises the following components: Protein: 220-260 parts; Fat: 100-160 parts; Carbohydrates: 600-800 parts; Dietary Fiber: 30-50 parts; Complex Trace Minerals: 0.68-0.98 parts; Complex Macro Minerals: 46-83 parts; Complex Vitamins: 2.6-3.1 parts; DHA: 2.45-4.7 parts; Arachidonic Acid: 0.07-0.09 parts. The protein-like substance is composed of 70-90 parts whey protein and 150-160 parts soy protein; The mass ratio of soybean protein to dietary fiber is 3-5:

1.

2. The nutritional composition according to claim 1, characterized in that: The fatty substance is a vegetable oil microcapsule powder made from 30-50 parts medium-chain triglycerides, 55-85 parts soybean oil, 15-25 parts low-erucic acid rapeseed oil, and the remainder being an edible carrier. The edible carrier is composed of 10-51 parts of maltodextrin, 2-17 parts of sodium caseinate, 0.2-2.2 parts of mono- and diglycerides of fatty acids, and 0.01-1.8 parts of vitamin E.

3. [Amended according to Rule 26, 11.09.2025] The nutritional composition according to claim 1 is characterized in that: The carbohydrate consists of 300-580 parts maltodextrin and 220-300 parts solid corn syrup.

4. The nutritional composition according to claim 1, characterized in that: The dietary fiber is composed of 10-20 parts of galactooligosaccharides and 20-30 parts of fructooligosaccharides.

5. The nutritional composition according to claim 1, characterized in that: The complex trace minerals consist of 0.009-0.02 parts copper sulfate, 0.60-0.74 parts ferric pyrophosphate, 0.0035-0.006 parts manganese sulfate, 0.000095-0.000097 parts sodium selenite, 0.06-0.26 parts zinc citrate, 0.0008-0.0018 parts potassium iodide, and the balance being an edible carrier.

6. The nutritional composition according to claim 1, characterized in that: The composite macromineral is composed of 32.7-46.1 parts tricalcium phosphate, 1.2-3.6 parts calcium carbonate, 3.1-5.1 parts magnesium carbonate, 4.5-12.2 parts potassium chloride, 3.1-9.2 parts dipotassium hydrogen phosphate, 1.4-6.8 parts sodium citrate, and the balance being an edible carrier.

7. The nutritional composition according to claim 1, characterized in that: The complex vitamin consists of 0.0045-0.015 parts retinyl palmitate, 0.00004-0.00008 parts vitamin D3, 0.2-0.5 parts dl-α-tocopherol acetate, 0.00033-0.00085 parts vitamin K1, 0.008-0.025 parts thiamine hydrochloride, 0.006-0.024 parts vitamin B2, 0.05-0.1 parts nicotinamide, 0.04-0.1 parts D-calcium pantothenate, 0.008-0.02 parts pyridoxine hydrochloride, 0.0001-0.0003 parts D-biotin, 0.001-0.004 parts folic acid, 0.000025-0.000045 parts cyanocobalamin, 2.09-2.31 parts sodium L-ascorbate, and the balance being an edible carrier.

8. The nutritional composition according to any one of claims 5 to 7, characterized in that: The edible carrier is maltodextrin.

9. Use of the nutritional composition according to any one of claims 1 to 8 in the preparation of a medicine for the prevention and / or treatment of precocious puberty in children.

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