Cardiovascular health-enhancing milk powder formulation

The milk powder formulation addresses the rising cardiovascular disease risk factors by combining specific medicinal and dietary elements, achieving effective reduction in blood fat, regulation of blood sugar, and lowering of blood pressure, thereby enhancing cardiovascular health.

WO2025015366A1PCT designated stage expired Publication Date: 2025-01-23GOTOP AUSTRALIA PTY LTD
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Patent Information

Application Number
PCT/AU2024/050678
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-07-20
Filing Date
2024-06-27
Publication Date
2025-01-23

AI Technical Summary

Technical Problem

The growing prevalence of hypertension, dyslipidemia, and diabetes in China poses a significant risk for cardiovascular disease, with existing prevention and control measures showing limitations, particularly in early stages of these conditions.

Method used

A milk powder formulation incorporating a combination of medicinal and dietary elements, including puerarin, bamboo leaf flavonoids, mulberry leaf flavonoids, dilongin peptide, and Lactobacillus casei, designed to reduce blood fat, regulate blood sugar, and lower blood pressure, thereby enhancing cardiovascular health.

Benefits of technology

The formulation demonstrates a synergistic effect in reducing blood fat, regulating blood sugar, and lowering blood pressure, as evidenced by adjunct hypoglycemic effects and improved circulatory efficiency in animal studies.

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Abstract

The present invention relates to a milk powder formulation designed to promote cardiovascular health and improve circulatory efficiency. The formulation includes puerarin, bamboo leaf flavonoids, mulberry leaf flavonoids, dilongin peptide, and active Lactobacillus casei, along with essential vitamins and minerals such as iron, calcium, magnesium, zinc, selenium, and vitamins A, D, E, C, and folic acid. Each 100 grams of the milk powder contains specified concentrations of these ingredients. The preparation method involves blending these components and spray-drying to create a homogenous powder. Experimental studies in zebrafish models demonstrate the formulation's significant hypoglycemic and circulatory benefits, including improved blood flow and reduced blood sugar levels. This innovative milk powder provides a convenient dietary option for enhancing cardiovascular health and managing blood sugar levels effectively.
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Description

Cardiovascular Health-Enhancing Milk Powder Formulation Field of the Invention

[0001] The present invention relates to the field of food technology and nutrition, particularly to a milk powder formulation designed to enhance cardiovascular health by addressing the risk factors associated with hypertension, dyslipidemia, and diabetes. Background of the Invention

[0002] With the progression of society and the economy, changes in the national lifestyle, particularly the aging population and rapid urbanisation, have led to a growing prevalence of unhealthy habits among residents. Consequently, the impact of cardiovascular disease risk factors on their health has significantly increased. Currently, the mortality rate from cardiovascular disease in China ranks highest among both urban and rural residents, accounting for 46.66% and 43.81%, respectively. This escalating rate is imposing an increasing economic burden on individuals and society.

[0003] The primary risk factors for cardiovascular disease are hypertension, dyslipidaemia (hyperlipidaemia), and diabetes, commonly referred to as the "three highs". According to the 2012-2015 China Hypertension Survey (CHS), around 39.1% of residents aged 18 years and older were found to have high blood pressure, estimated to be around 435 million individuals. The prevalence of hypertension has been rising from 1958 to 2015, with a crude prevalence rate of 27.9% among Chinese residents aged 18 years and older. The prevalence is significantly higher among older individuals (59.8% for those aged 75 and above) and younger adults (5.1% for those aged 18-34).

[0004] Research from 2012 to 2015 showed that the overall prevalence of dyslipidaemia (hyperlipidaemia) in Chinese residents aged 35 years and older was 34.7%, while the age- and sex-standardised prevalence among those aged 40 years and older was 43%, according to the China Stroke Screening and Prevention Program (CNSSPP) survey in 2014. A cross-sectional study conducted from 2015 to 2017found that the prevalence of diabetes in Chinese adults was 11.2% based on WHO diagnostic criteria. The estimated number of adults with diabetes in mainland China is currently 129.8 million, with early detection rates at 35.2%.

[0005] Cardiovascular disease poses the highest morbidity and mortality rates in the country, making prevention and control measures crucial. The key manifestation of cardiovascular disease is related to the "three highs." Early stages of these conditions are often met with resistance to drug treatment, leading to serious heart issues such as myocardial infarction and stroke. To address this, incorporating nutrients beneficial for cardiovascular health in dairy products could encourage people to consume them, thereby helping to prevent cardiovascular diseases.

[0006] Hypertension, hyperglycaemia, and hyperlipidaemia are interconnected and can exacerbate each other. Many hypertensive patients experience abnormal lipid metabolism, resulting in higher cholesterol and triglyceride levels and lower high - density lipoprotein cholesterol levels. Dyslipidaemia can lead to atherosclerosis, which, in turn, can cause coronary heart disease and affect blood pressure, leading to hypertension. Moreover, hyperlipidaemia can reduce insulin sensitivity and cause insulin resistance, contributing to increased blood sugar levels. Individuals with diabetes may experience disruptions in glucose metabolism, further impacting blood lipid metabolism. Summary of the Disclosure

[0007] The described milk powder formulation addresses the shortcomings of previous approaches by providing a formulation and preparation method aimed at promoting cardiovascular health. This formulation incorporates a combination of medicinal and dietary elements, resulting in a synergistic effect that effectively reduces blood fat, regulates blood sugar, and lowers blood pressure. Specifically, each 100 grams of the milk powder formulation contains 100-300 mg of puerarin, 150- 300 mg of bamboo leaf flavonoids, 100-300 mg of mulberry leaf flavonoids, and 200 mg of dilongin peptide, along with 5-10 billion active Lactobacillus casei.

[0008] Additionally, the formulation may include other elements. For every 100 grams, it may also contain 6-10 mg of iron, 400-600 μg of vitamin A, 6-8 μg of vitamin D, and200-100 μg of folic acid, totalling 500 μg. The preferred formula incorporates at least one of the following components per 100 grams: calcium (600-3800 mg), magnesium (200-400 mg), zinc (3-8 mg), selenium (15-30 μg), vitamin E (10-12 mg), and vitamin C (30-60 mg).

[0009] Other aspects of the invention are also disclosed. Description of Embodiments

[0010] A milk powder formulation for enhancing cardiovascular health, according to an embodiment, consists of the following raw materials in specific mass proportions: 80-120 parts kudzu root, 80-120 parts light bamboo leaves, 80-120 parts mulberry leaves, 480-550 parts skimmed milk powder, 120-150 parts whey powder, 80-120 parts whole milk powder, 180-220 parts isomalto-oligosaccharide or fructo- oligosaccharide, 4-6 parts earthworm protein peptide powder, 4-6 parts Luo Han Guo powder, and 4-6 parts Lactobacillus casei. In the preferred embodiment, the activity per gram of Lactobacillus casei is set at 8-12 billion. Additionally, the raw materials may include mineral and vitamin nutrition packages.

[0011] The preparation method for the milk powder formulation involves the following steps: First, prepare a solution containing kudzu root powder, mulberry leaf powder, and bamboo leaf powder or their respective extracts. Then, add skim milk powder, whey powder, whole milk powder, mineral nutrition package, and vitamin nutrition package to this solution, thoroughly mix, and then spray dry to obtain the milk powder. Finally, stir and blend earthworm protein peptide powder, Lactobacillus casei, isomalto-oligosaccharide or fructo-oligosaccharide, and Luo Han Guo powder into the milk powder, enhancing its cardiovascular benefits.

[0012] The preferred procedure for creating the solution containing kudzu root powder, mulberry leaf powder, and bamboo leaf powder is as follows: Add kudzu root powder, mulberry leaf powder, and bamboo leaf powder to water at 80-90°C, then boil at 80-100°C for over 40 minutes. Filter the mixture with a 100-mesh filter to obtain separate solutions. Finally, combine these solutions to obtain a mixture.

[0013] The preferred approach for obtaining the mixed material containing pueraria root extract, mulberry leaf extract, and bamboo leaf extract involves similar steps:Add each powder to water at 80-90°C, boil at 80-100°C for more than 40 minutes, then filter with a 100-mesh filter. Concentrate each solution to obtain the extracts, then mix them.

[0014] The content of puerarin in kudzu root, mulberry flavonoids in mulberry leaves, and bamboo leaf flavonoids in bamboo leaves is approximately 3%. These compounds are water-soluble, making direct extraction with boiling water efficient and cost-effective, resulting in high extraction content. Kudzu root powder is obtained by crushing kudzu root to an 80-mesh sieve, while bamboo leaf powder and mulberry leaf powder are similarly obtained by crushing to an 80-mesh sieve. The stirring and mixing time during the preparation process is set to be at least 30 minutes. Adjunct Hypoglycemic Efficacy Test Results

[0015] In an animal study conducted to test the hypoglycemic effect of the current milk powder formulation, zebrafish of the wild-type AB strain were bred through natural pairing and reproduction. Zebrafish aged 5 days post -fertilization (5 dpf) were used for evaluating the maximum detection concentration (MTC) and hypoglycemic effects of the milk powder.

[0016] To determine the MTC, 30 wild-type AB strain zebrafish larvae at 5 dpf were randomly assigned to each of the 25 ml containers. Water-soluble samples (concentrations shown in Table 1-1), a normal control group, and model control groups were set up. A hyperglycaemia model was established by providing a 0.15% egg yolk solution during the day and a 3% glucose solution at night after removing the sample, except for the normal control. The MTC of the sample on the model zebrafish was assessed after 18 hours of treatment at 28°C.

[0017] For evaluating the adjunct hypoglycemic effects, 30 wild-type AB strain zebrafish larvae at 5 dpf were randomly assigned to each of the 25 ml containers. Water-soluble samples (concentrations shown in Table 1-2), a positive control (pioglitazone hydrochlor ide, 20.0 μg / ml), a normal control group, and model control groups were set up. The hyperglycaemia model was established using the same method as in the MTC test. After 48 hours of treatment at 28°C, the zebrafish were washed with fish tank water three times, and their glucose levels were measuredusing a glucometer. The overall blood sugar values of the zebrafish were statistically analysed to evaluate the effectiveness in assisting blood sugar reduction.

[0018] Under the experimental conditions, the MTC of the milk powder formulation on the model zebrafish was found to be 10,000 μg / mL, as shown in Table 1 -1:

[0019] Furthermore, under the experimental conditions, the milk powder formulation demonstrated an adjunct hypoglycemic effect, as evidenced by a decrease in the blood sugar levels of zebrafish (Fig. 1-1, Table 1-1).

[0020] In this experimental setting, the milk powder formulation exhibits an adjunct hypoglycemic effect, as evidenced by a notable reduction in blood sugar levels in zebrafish. Circulatory Improvement Efficacy Test Results

[0021] To assess the impact of the milk powder formulation on circulatory efficiency, an experiment was conducted using melanin allele mutant Albino strain zebrafish larvae. Thirty zebrafish larvae at 5 dpf were randomly assigned to each of the 25 ml containers. Water-soluble samples (concentrations shown in Table 1-1), a positive control (pioglitazone hydrochloride, 20.0 μg / ml), a normal control group, and model control groups were established. A hyperglycaemia model was induced by providing a 0.15% egg yolk solution during the day and a 3% glucose solution at night after removing the sample, except for the normal control.

[0022] After 48 hours of treatment at 28°C, ten zebrafish were randomly selected from each experimental group and placed under the cardiovascular analysis system to record their blood flow. The recorded data were analysed using ZebraBlood 3.4 blood flow analysis software to quantify the parameters and assess the efficacy of the milk powder formulation in enhancing blood flow rate. Statistical analysis was conducted using SPSS 26.0 software, and the data were expressed as mean ± SE, with p < 0.05 indicating statistical significance.

[0023] The results indicate that, under the conditions of this experiment, the milk powder formulation significantly improves circulation, specifically manifested by its auxiliary effect in enhancing blood flow rate (Fig. 2-1, Table 2-1)..

[0024] Clinical studies have validated that diabetic patients experience reduced splenic artery blood flow velocity and increased resistance index, along with a rise in carotid artery shear rate. Furthermore, blood flow-mediated vascular function declines, and the blood flow velocity in certain arteries (e.g., ophthalmic artery, retinalartery, posterior ciliary artery) is lower compared to healthy individuals of the same age. Additionally, the pulse index and resistance index are higher than those of age - matched healthy individuals.

[0025] Based on these findings, it is speculated that the present milk powder formulation improves blood flow efficiency through its effective ingredients such as kudzu powder, mulberry leaf powder, bamboo leaf flavones, and siraitia grosvenorii fruit powder. These components help reduce blood sugar levels, enhance vascular relaxation function, and lower blood flow resistance.

[0026] The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the invention. However, it will be apparent to one skilled in the art that specific details are not required in order to practise the invention. Thus, the foregoing descriptions of specific embodiments of the invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed as obviously many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, thereby enabling others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. It is intended that the following claims and their equivalents define the scope of the invention.

Claims

Claims 1. A milk powder formulation, wherein every 100 grams of the milk powder formulation contains 100-300 mg of puerarin, 150-300 mg of bamboo leaf flavonoids, 100-300 mg of mulberry leaf flavonoids, 200-500 mg of dilongin peptide, and 5-10 billion active Lactobacillus casei.

2. The milk powder formulation as claimed in claim 1, wherein every 100 grams of the milk powder formulation also contains the following components: 6-10 mg of iron, 400-600 μg of vitamin A, 6-8 μg of vitamin D, and 200-500 μg of folic acid.

3. The milk powder formulation as claimed in claim 1, wherein every 100 grams of the milk powder formulation also contains at least one of the following components: 600- 3800 mg of calcium, 200-400 mg of magnesium, 3-8 mg of zinc, 15-30 μg of selenium, 10-12 mg of vitamin E, and 30-60 mg of vitamin C.

4. The milk powder formulation as claimed in claim 1, wherein the milk powder formulation comprises the following raw materials in parts by mass: 80-120 parts of kudzu root, 80-120 parts of light bamboo leaves, 80-120 parts of mulberry leaves, 480-550 parts of skimmed milk powder, 120-150 parts of whey powder, 80-120 parts of whole milk powder, 180-220 parts of isomalto-oligosaccharide or fructo- oligosaccharide, 4-6 parts of dilongin peptide powder, 4-6 parts of Luo Han Guo powder, and 4-6 parts of Lactobacillus casei.

5. The milk powder formulation as claimed in claim 1 or 4, wherein the activity of Lactobacillus casei is 8-12 billion per gram.

6. The milk powder formulation as claimed in claim 4, wherein the raw materials of the milk powder formulation also include a mineral nutrition package and a vitamin nutrition package.

7. A method for preparing the milk powder formulation as claimed in any one of claims 1-6, wherein the method comprises the following steps: adding pueraria root powder, mulberry leaf powder, and bamboo leaf powder to a solution containing kudzu root extract, mulberry leaf extract, and bamboo leaf extract; adding skimmed milk powder, whey powder, whole milk powder, mineral nutrition package, and vitamin nutrition package to the solution; mixing and then spray drying; then adding dilongin peptide powder, Lactobacillus casei, isomalto-oligosaccharide or fructo- oligosaccharide, and Luo Han Guo powder; stirring and mixing to obtain the milk powder formulation.

8. The method for preparing the milk powder formulation as claimed in claim 7, wherein the preparation process of the solution containing pueraria root powder, mulberry leaf powder, and bamboo leaf powder is as follows: add pueraria root powder, mulberry leaf powder, and bamboo leaf powder to water at 80-90°C, boil in water at 80-100°C for more than 40 minutes, and then filter with a 100-mesh filter to obtain solutions containing pueraria root powder and mulberry leaf powder.

9. The method for preparing the milk powder formulation as claimed in claim 7, wherein the process of obtaining the mixture containing kudzu root extract, mulberry leaf extract, and bamboo leaf extract is as follows: add kudzu root powder, mulberry leaf powder, and bamboo leaf powder to water at 80-90°C respectively, and mix them at 80-100°C; after boiling in water for more than 40 minutes, filter with a 100-mesh filter to obtain separate solutions; then concentrate them separately to obtain kudzu root extract, mulberry leaf extract, and bamboo leaf extract; and mix the extracts to obtain a mixture containing the extract of kudzu root, the extract of mulberry leaves, and the extract of bamboo leaves.

10. The method for preparing the milk powder formulation as claimed in claim 8 or 9, wherein the kudzu root powder is obtained by crushing kudzu root into an 80-mesh sieve and taking the under-sieve, the bamboo leaf powder is obtained by crushingbamboo leaves into an 80-mesh sieve, and the mulberry leaf powder is obtained by crushing mulberry leaves into an 80-mesh sieve.

Citation Information

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