Uses of β-1,3 / α-1,3-glucan in the preparation of functional foods that help maintain healthy blood pressure levels

Abstract

This invention provides the use of β-1,3 / α-1,3-glucan in the preparation of functional foods that help maintain healthy blood pressure levels, belonging to the field of health foods. This invention provides a food-grade β-1,3 / α-1,3-glucan, which has been shown to significantly reduce systolic blood pressure, diastolic blood pressure, and pulse pressure, exhibiting high safety and broad applicability, providing a reliable solution for comprehensive blood pressure management.

Description

Technical Field

[0001] This invention relates to the use of β-1,3 / α-1,3-glucan in the preparation of functional foods that help maintain healthy blood pressure levels, and belongs to the field of health food. Background Technology

[0002] Hypertension is a prevalent chronic cardiovascular disease worldwide. Its core harm stems from the progressive damage to target organs caused by persistently abnormally high blood pressure. Abnormalities in systolic blood pressure, diastolic blood pressure, and pulse pressure are key indicators for assessing blood pressure health status and cardiovascular risk.

[0003] High systolic blood pressure: If systolic blood pressure (peak arterial blood pressure during cardiac systole) is consistently >120 mmHg, it will directly increase the pressure on the arterial walls, accelerate the process of atherosclerosis, and lead to decreased vascular elasticity; at the same time, it will increase the pumping load on the heart, induce left ventricular hypertrophy, increase the risk of coronary heart disease and heart failure, and may also damage glomerular capillaries, leading to chronic kidney disease.

[0004] High diastolic blood pressure: If diastolic blood pressure (the lowest value of arterial blood pressure during diastole) is consistently >80 mmHg, it will lead to increased peripheral vascular resistance and affect blood perfusion of tissues and organs; it has a particularly significant impact on cerebral blood vessels, easily causing small vessel disease of the brain, increasing the risk of lacunar infarction and cognitive decline, and at the same time aggravating interstitial damage to the kidneys.

[0005] Excessive pulse pressure: If the pulse pressure (the difference between systolic and diastolic blood pressure) is consistently >60 mmHg, it often indicates decreased arterial elasticity and increased vascular stiffness, which is an important marker of atherosclerosis. Excessive pulse pressure not only further reduces the buffering capacity of blood vessels, but also increases the probability of serious cardiovascular events such as aortic dissection, stroke, and myocardial infarction, especially in middle-aged and elderly people.

[0006] Currently, blood pressure management is mainly divided into pharmacological and non-pharmacological interventions. Non-pharmacological interventions, such as a low-salt diet and regular exercise, have a limited range of effects on blood pressure regulation and require strict long-term adherence, leading to poor compliance. This makes it difficult to meet the blood pressure management needs of individuals with different blood pressure states (especially those with high-normal blood pressure and mild blood pressure abnormalities), and cannot simultaneously improve systolic blood pressure, diastolic blood pressure, and pulse pressure. Furthermore, differences in genetic background and other factors among different populations can affect the effectiveness of non-pharmacological interventions, making it difficult for some individuals to achieve ideal blood pressure management through existing non-pharmacological methods.

[0007] β-glucan, as a class of functional polysaccharides, is widely used in the health food field due to its various activities. However, the structural diversity of β-glucan determines its functional specificity; β-glucans from different glycosidic bond linkages and sources exhibit significant differences in biological activity. Among them, β-1,3 / α-1,3-glucan is a novel type of glucan, formed by β-1,3 bonds linked to α-1,3 bonds, creating a chain-like structure of repeating units without side chains. This structure is fundamentally different from traditional β-glucans (such as yeast β-1,3 / 1,6-glucan and oat β-1,3 / 1,4-glucan). This novel dextran is derived from the fermentation product of *Rhizobium pusa*, with a purity ≥90%. It has passed the safety assessment by the National Health Commission (Announcement No. 5 of 2021), and its naturalness and safety have been authoritatively certified. β-1,3 / α-1,3-glucan is composed of glucose molecules linked by alternating β-1,3 and α-1,3 glycosidic bonds, resulting in a well-defined unit structure. This structure endows it with unique biological activity and physical properties.

[0008] CN202111653671.4, Invention Title: A β-glucan candy tablet with hypoglycemic and blood pressure lowering health function and its preparation method, discloses a β-glucan candy tablet with hypoglycemic and blood pressure lowering health function. β-glucan is obtained by enzymatic hydrolysis of barley and oats, which are rich in β-glucan. The end product of the enzymatic hydrolysis is used as a substrate to provide nutrients for edible fungi fermentation to produce more β-glucan. After separation and purification, a β-glucan composition is finally obtained and used as the main component in the production of β-glucan candy tablets with hypoglycemic and blood pressure lowering health function.

[0009] Currently, there are no research reports on the application of β-1,3 / α-1,3-glucan in lowering blood pressure or maintaining healthy blood pressure levels. Summary of the Invention

[0010] Existing non-pharmacological blood pressure lowering interventions have limited adjustment range, poor long-term patient compliance, and cannot simultaneously improve vascular elasticity and pulse pressure difference. This invention provides a new use for β-1,3 / α-1,3-glucan.

[0011] This invention provides the use of β-1,3 / α-1,3-glucan in the preparation of functional foods that help maintain healthy blood pressure levels.

[0012] The aforementioned functional food is prepared into a commonly used food formulation by adding acceptable excipients or auxiliary ingredients, with β-1,3 / α-1,3-glucan as the active ingredient.

[0013] The preparation described is an oral preparation.

[0014] Compared with the β-glucan disclosed in application number 202310243280.8, the β-1,3 / α-1,3-glucan of this invention is a "β / α alternating bond polysaccharide produced by microbial fermentation", while oat β-(1→3,1→4)-glucan is a "natural linear polysaccharide with β-1,4 as the main component and β-1,3 as the discontinuous component in plant cell walls". The two are completely different in terms of bond type, configuration, source and molecular weight range.

[0015] The beneficial effects of this invention are:

[0016] This invention provides a food-grade β-1,3 / α-1,3-glucan, which has been shown to significantly reduce systolic blood pressure, diastolic blood pressure, and pulse pressure. It is highly safe, suitable for a wide range of people, and provides a reliable solution for comprehensive blood pressure management. Detailed Implementation

[0017] Experimental Example 1: Experiment on the maintenance of healthy blood pressure levels by β-1,3 / α-1,3-glucan of the present invention

[0018] The human trials of β-1,3 / α-1,3-glucan for lowering blood pressure described in this invention are summarized below:

[0019] 1. Target audience selection

[0020] This study included a total of 79 participants, comprising 21 people with normal blood pressure, 44 people with high-normal blood pressure, and 14 people with hypertension.

[0021] 2. Diagnostic criteria

[0022] The criteria for determining the target population are shown in Table 1:

[0023] Table 1 Judgment Criteria

[0024] Classification Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) Normal blood pressure <120 and ＜80 High normal value 120~139 and / or 80~89 hypertension ≥140 and / or ≥90

[0025] Note: When systolic and diastolic blood pressure belong to different levels, the higher level shall prevail.

[0026] (Refer to the standards of the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024 Revised Edition)).

[0027] 3. Inclusion criteria

[0028] (1) Those who meet the above blood pressure determination criteria;

[0029] (2) Age 18-65 years old, gender not limited;

[0030] (3) Voluntarily participate in this trial and sign an informed consent form;

[0031] (4) Able to cooperate in blood pressure monitoring and follow-up.

[0032] 4. Exclusion criteria

[0033] (1) Patients with secondary hypertension (such as renal hypertension, endocrine hypertension, etc.);

[0034] (2) Patients with severe cardiovascular and cerebrovascular diseases or liver and kidney failure;

[0035] (3) Have taken any lipid-lowering drugs, hypoglycemic drugs, or other medications that may affect blood pressure within the past month;

[0036] (4) Those who have had a myocardial infarction or stroke within the past 3 months;

[0037] (5) Individuals allergic to β-1,3 / α-1,3-glucan;

[0038] (6) Pregnant or breastfeeding women or those planning to conceive;

[0039] (7) Those currently participating in other clinical trials;

[0040] (8) Mental illness or cognitive impairment that prevents researchers from cooperating.

[0041] 5. Observation Indicators

[0042] 5.1 Efficacy evaluation indicators

[0043] (1) Main indicators: systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) before and after intervention. Electronic blood pressure monitors were used for measurement. Subjects sat quietly for 15 minutes before measurement and avoided smoking and drinking coffee. Measurements were taken 3 times between 8 and 10 am on the morning of the test, with an interval of 2 minutes. The average value was taken as the final blood pressure value.

[0044] (2) The pulse pressure difference is the difference between systolic and diastolic blood pressure.

[0045] 5.2 Safety Indicators

[0046] General checks include: heart rate, pulse, and weight.

[0047] Laboratory tests: complete blood count, urinalysis, liver function tests (ALT, AST, etc.), kidney function tests (creatinine, blood urea nitrogen, etc.);

[0048] Adverse reaction record: Observe for discomfort symptoms (such as dizziness, gastrointestinal reactions, etc.) that occur during the intervention, and record their occurrence time, severity and outcome.

[0049] 6. Intervention methods and precautions

[0050] Take 350mg of β-1,3 / α-1,3-glucan twice a day on an empty stomach, dissolved in warm water, for four consecutive weeks.

[0051] Precautions: Both groups are prohibited from drinking alcohol and smoking. Daily salt intake should be less than 5g. Avoid emotional fluctuations and staying up late. Monitor blood pressure regularly. If a sudden drop in blood pressure or severe discomfort occurs, stop taking the medication immediately and take appropriate symptomatic treatment. Do not take other antihypertensive medications at the same time.

[0052] 7. Statistical Analysis

[0053] SPSS statistical software was used for data analysis.

[0054] Quantitative data are expressed as mean ± standard deviation (x ± s). Paired-samples t-tests were used to compare data before and after the intervention, and P < 0.05 was considered statistically significant.

[0055] 8. Results

[0056] 8.1 Comparison of subjects before and after intervention

[0057] Table 2 Blood pressure indicators before and after intervention

[0058]

[0059] Note: * indicates the significance of the post-intervention value compared to the pre-intervention value within the same group (***, p<0.001; **, p<0.01).

[0060] Table 3. Number of people in each category before and after the intervention

[0061]

[0062] Results analysis:

[0063] In the experimental group of 79 subjects, after 4 weeks of β-1,3 / α-1,3-glucan intervention, systolic blood pressure, diastolic blood pressure, and pulse pressure all showed statistically significant reductions compared to before the intervention. Furthermore, this glucan demonstrated good safety, with no serious adverse reactions observed during the trial, suggesting it can be an effective intervention for individuals with hypertension. Specific changes are as follows:

[0064] Systolic blood pressure: The mean value before intervention was 125.89±14.15 mmHg, and after intervention it decreased to 117.67±13.77 mmHg, with an average reduction of 8.22±6.95 mmHg, and P<0.001. This indicates that the dextran has a clear regulatory effect on arterial pressure during cardiac systole, can effectively reduce the load on the arterial wall, and delay the progression of atherosclerosis.

[0065] Diastolic blood pressure: The mean value before intervention was 75.89±9.94 mmHg, and it decreased to 73.23±8.48 mmHg after intervention, with an average reduction of 2.66±7.65 mmHg (P<0.01). The reduction in diastolic blood pressure can effectively reduce peripheral vascular resistance and improve blood perfusion of tissues and organs, especially with a significant protective effect on cerebral blood vessels. This reduction can lower the risk of cerebral small vessel disease.

[0066] Pulse pressure: The mean pulse pressure before intervention was 50.00±11.12 mmHg, which decreased to 44.44±9.64 mmHg after intervention, a decrease of 5.56±8.95 mmHg (P<0.001). A reduced pulse pressure indicates improved arterial elasticity and decreased vascular stiffness, which can significantly reduce the risk of serious cardiovascular events such as aortic dissection, stroke, and myocardial infarction.

[0067] 8.2 Analysis of the conversion effect of blood pressure classification in the population

[0068] After intervention with β-1,3 / α-1,3-glucan, 21 people who were in the normal blood pressure group before taking the medication maintained their normal blood pressure levels. After taking the medication, the number of people with normal blood pressure increased from 21 to 47 (an increase of 26 people), with the new participants coming from the high-normal and high-hypertension groups, which helps maintain healthy blood pressure levels. The number of people with high-normal blood pressure decreased from 44 to 23 (a decrease of 21 people), effectively reducing their risk of progressing to hypertension. The number of people with hypertension decreased from 14 to 9 (a decrease of 5 people), which can be used as an auxiliary intervention to provide a safer supplementary option.

[0069] In summary, the β-1,3 / α-1,3-glucan intervention of this invention has a clear effect on maintaining healthy blood pressure levels: data from human trials confirm that this glucan can simultaneously and significantly reduce systolic blood pressure, diastolic blood pressure, and pulse pressure, comprehensively reducing cardiovascular risk: it not only lowers blood pressure values ​​but also narrows pulse pressure, making up for the shortcomings of existing intervention methods in regulating pulse pressure.

Claims

1. Use of β-1, 3 / α-1, 3-glucan for the manufacture of a functional food for helping to maintain a healthy level of blood pressure.

2. Use according to claim 1, characterized in that: The functional food is prepared by using β-1, 3 / α-1, 3-glucan as an active ingredient and adding acceptable adjuvants to prepare a preparation commonly used in foods.

3. Use according to claim 2, characterized in that: The preparation is an oral preparation.

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