Patent Description:
Fish is known to contain plenty of n-<NUM> polyunsaturated fatty acid which is unsaturated fatty acid. Many studies have been reported to indicate that eating fish frequently reduces a risk of suffering from cardiovascular disease. In particular, an epidemiological study in Greenland is famous as the pioneering epidemiological study in which eicosapentaenoic acid (EPA) which is an n-<NUM> polyunsaturated fatty acid has gained attention in the prevention or treatment of cardiovascular disease. The epidemiological study revealed that there were fewer individuals who developed acute myocardial infarction in the Inuit, the original inhabitants in Greenland, and also less mortality due to ischemic heart disease. Further, as a result of studying their diets, it was revealed that much n-<NUM> polyunsaturated fatty acid, such as EPA and docosahexaenoic acid (DHA), was often consumed by a dietary routine of earless seal and fish, while there was less intake of n-<NUM> polyunsaturated fatty acids that are often included in terrestrial animals and plants. It has been reported that the difference in fatty acid compositions ingested as meals was a factor whereby the onset rate of acute myocardial infarction and mortality due to ischemic heart disease in Inuit were low (Non-Patent Documents <NUM> to <NUM>). In addition, in human clinical trials, effects of EPA and DHA in decreasing neutral fat have been shown, but it is known that little or no cholesterol-lowering effect is observed.

On the other hand, it has been reported that long chain monounsaturated fatty acids (LC-MUFA) having <NUM> and <NUM> carbon atoms, which are known to be abundant in saury oil and Alaska pollock oil, have a cholesterol-lowering effect (Patent Document <NUM>). It has also been discovered that dietary induced obesity model mice and type <NUM> diabetic model mice have been found to show effects such as the reduction of total cholesterol, LDL-cholesterol, neutral fat and blood glucose levels in blood, and the improvement of insulin resistance by ingesting saury oil and Alaska pollock oil (Non-Patent Document <NUM> to <NUM>). A similar effect has also been confirmed with oils and fats in which LC-MUFAs are selectively concentrated (Non-Patent Document <NUM>). In this context, there is a report that increasing the amount of seafood ingestion in men reduces the risk of developing diabetes from a cohort study of fifty thousand people, Japanese men and women. In particular, the study also reports that increasing the amount ingested of small size and intermediate size fish such as saury and mackerel and fish having a lot of oils such as salmon reduces the risk (Non-Patent Document <NUM>).

Also, a study with an artery-cure model mice reports that LC-MUFA ingestion suppressed formation of atherosclerotic plaque in the aortic sinus, and that this is likely to be a result of a protective effect combined with the decrease in blood inflammatory cytokine concentration and the promotion of cholesterol removal from macrophages by the stimulation of the PPAR signaling pathway (Non-Patent Document <NUM>). However, no effect on the vascular endothelial function itself due to LC-MUFA ingestion is disclosed in Non-Patent Document <NUM>.

Vascular endothelial cells regulate vasoconstriction and relaxation of vascular walls by secreting vasoactive substances such as nitric oxide (NO) and endothelin. Vascular endothelial cells are also responsible for functions such as maintaining blood pressure and modulating vascular permeability. It is believed that such reduced function of vascular endothelial cells (i.e. vascular endothelial function) leads to a variety of diseases, and is known to be involved in the development and progression of atherosclerosis, for example. In recent years, blood flow-dependent vasodilation reactions (Flow Mediated Dilation (FMD)) test has been focused on non-invasive vascular endothelial function studies. A subject with a low FMD value is considered to be susceptible to events of the cardiovascular vessel (Non-Patent Document <NUM>). FMD tests have also been insurance-applied in Japan and have been used for early discovery and early treatment of various diseases based on atherosclerosis. Non-Patent Document <NUM> discusses the potential therapeutic value of dietary LC-MUFA-rich marine oil for improving cardiovascular diseases risk factors. Non-Patent Document <NUM> studies decrease of atherosclerosis and alternation of lipoprotein proteomes by dietary supplementation with long-chain monounsaturated fatty acid isomers. Non-Patent Document <NUM> concerns cardioprotection by dietary LC-MUFA.

Disease due to reduced vascular endothelial function has recently become a problem, and there has been a demand for an approach to improve the vascular endothelial function that is safe and can be performed over a long period of time.

In addition, among LC-MUFA, positional isomers such as C20:1n-<NUM> and C22:1n-<NUM> are also included in fish oils from fish species such as Alaska pollock, mackerel, and salmon in addition to saury, but they are scarcely present in plant oils. Because saury and Alaska pollock are highly popular fish in Japan and fish with high industrial value, there is a strong desire to develop new applications for fish oils that are enriched in LC-MUFA, which are prepared from these fish species.

An object of the present invention is to provide novel applications of components of fish oils, including LC-MUFA, in particular for health-promoting applications.

As a result of diligent research to achieve the above object, the inventors have found that Flow Mediated Dilation was improved by ingesting saury oil that is enriched in LC-MUFA. While reports have previously been made on the effect of EPA and DHA on vascular endothelial function, LC-MUFA rich oils has not been known to affect vascular endothelial function.

The inventors have also found that morning awake was improved by ingesting saury oil that LC-MUFA was rich. To date, LC-MUFA rich oils has not been known to affect sleep.

The inventors have further studied based on these findings, and completed the present invention.

Therefore, the present invention is as follows.

In accordance with the present invention, there is provided a composition for reducing the risk of suffering from hypertension containing components of LC-MUFA rich fish oil, such as saury oil.

The present invention will be specifically described below.

Note that the following abbreviations may be used herein:.

The present invention provides a composition for reducing the risk of suffering from hypertension, including an ingredient selected from monounsaturated fatty acids having <NUM> or more carbon atoms, salts thereof, and esters thereof as active ingredient, in which the ratio of monounsaturated fatty acid having <NUM> or more carbon atoms to total fatty acids in the composition is <NUM> wt% or greater, and the active ingredient is derived from a fish oil (hereinafter may be referred to as "composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention").

As described below, fish oils have a high content of monounsaturated fatty acids having <NUM> or more carbon atoms. Therefore, the active ingredient in the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention is derived from fish oils (e.g. saury oil).

For example, saury crude oil is typically taken by the following method, similar to other fish oils. Whole saury or the processed residues such as fish heads, skins, backbones, and viscus gained by fish processing are crushed, steamed and simmered, and then squeezed to separate them into broth (stickwater, SW) and squeezed meal. The oil and fat obtained together with the broth are separated from the broth by centrifugal separation.

<NPL>on) describes that fatty acids of saury (with skins, raw) contain <NUM> wt% of docosenoic acid (C22:<NUM>), <NUM> wt% of icosenoic acid (C20:<NUM>), and the total amount of monounsaturated fatty acids is <NUM> wt%. Saury oil is characterized by having a larger content of monounsaturated fatty acids among fish oils.

The crude oil of fish oil is converted to a refined fish oil by purification steps such as degumming, deacidification, bleaching and deodorizing. The refined fish oil can also be used as a source for the ingredient selected from a monounsaturated fatty acid having <NUM> or more carbon atoms, a salt thereof, and an ester thereof.

In one aspect, an oil having higher concentration of the monounsaturated fatty acid may be used as a source for the ingredient selected from a monounsaturated fatty acid having <NUM> or more carbon atoms, a salt thereof, and an ester thereof. In this case, an MUFA concentrated triglyceride can be obtained by a method of concentrating using a lipase reaction, or a method of ethyl-esterification of the monounsaturated fatty acid and concentrating the ethyl ester, and then trans-esterifying with glycerin to reconstitute into the triglyceride.

Monounsaturated fatty acids having <NUM> or more carbon atoms include monounsaturated fatty acids having <NUM> carbon atoms (C20:<NUM>) (for example, C20:<NUM> n-<NUM>, C20:<NUM> n-<NUM>, and C20:<NUM> n-<NUM>), monounsaturated fatty acids having <NUM> carbon atoms (C22:<NUM>) (for example, C22:<NUM> n-<NUM>, C22:<NUM> n-<NUM>, C22:<NUM> n-<NUM>, and C22:<NUM> n-<NUM>), and monounsaturated fatty acids having <NUM> carbon atoms (C24:<NUM>) (for example, C24:<NUM> n-<NUM>). In a preferred aspect, the active ingredient of the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention is an ingredient selected from C20:<NUM>, a salt thereof, and an ester thereof, an ingredient selected from C22:<NUM>, a salt thereof, and an ester thereof, or combination thereof.

The content of C22:<NUM> and C20:<NUM> varies depending on the type of fish. Examples of fish with the high content of C22:<NUM> and C20:<NUM> include fish of Scomberesocidae such as saury, fish of Gadidae such as Pacific cod, Alaska pollock, Atlantic cod, and sablefish, fish of Salmonida such as chum salmon, silver salmon, sockeye salmon, pink salmon, Atlantic salmon, and rainbow trout, fish of Osmeriformes such as capelin and smelt, and Clupeidae such as Pacific herring. In addition, a relatively large amount of LC-MUFAs is also contained in fish such as sand lance, tuna, mackerel, and alfonsino. A large amount of LC-MUFAs is also contained in liver oil of sharks such as spiny dogfish, basking shark, and silver chimaera. In an embodiment of the present invention, fish oils prepared from these fish can be used as they are, or can be used after purifying or concentrating.

The ratio of the monounsaturated fatty acid having <NUM> or more carbon atoms to the total fatty acids in the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention is <NUM> wt% or greater, for example, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, <NUM> wt% or greater, or <NUM> wt% or greater.

In an embodiment of the present specification, the ratio of the fatty acid to the total fatty acids in the composition (wt%) is calculated by the value measured by gas chromatography after esterifying the ingredient in the composition according to AOCS official method Celb-<NUM>, unless otherwise specified. By the content of fatty acids, it also means the ratio of the fatty acid (wt%) to the total fatty acids described above. The analytical conditions used for gas chromatography are listed below.

Examples of salts of the monounsaturated fatty acid having <NUM> or more carbon atoms in an embodiment of the present invention include potassium salts and sodium salts. In addition, examples of esters of the monounsaturated fatty acid having <NUM> or more carbon atoms include esters of a lower alcohol having <NUM> carbon atoms or less (for example, methyl esters, ethyl esters, n-propyl esters, i-propyl esters, n-butyl esters, s-butyl esters, t-butyl esters, and n-pentyl esters), esters with glycerin such as monoglycerides, diglycerides, and triglycerides (i.e., glycerides), and phospholipids. In a preferred aspect, the active ingredient of the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention is a glyceride containing a monounsaturated fatty acid having from <NUM> or more carbon atoms as the constituent fatty acid, and more preferably triglycerides.

As the monounsaturated fatty acid having from <NUM> or more carbon atoms in the present invention, fish oils containing free monounsaturated fatty acids having from <NUM> or more carbon atoms can be used as they are, or can be used after purifying or concentrating. In addition, as esters of the monounsaturated fatty acid having <NUM> or more carbon atoms, fish oil containing a glyceride containing monounsaturated fatty acids having from <NUM> or more carbon atoms as the constituent fatty acid can be used as they are, or can be used after purifying or concentrating.

Furthermore, a fractionated oil obtained by esterifying fish oil and then fractionating them by high performance liquid chromatography can be used as esters of the monounsaturated fatty acid having <NUM> or more carbon atoms. Fractionated oils include C20:<NUM> concentrated fractionated oils, C22:<NUM> concentrated fractionated oils, and C24:<NUM> concentrated fractionated oils.

The composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention may further include an n-<NUM> polyunsaturated fatty acid and an n-<NUM> polyunsaturated fatty acid. In this case, the area ratio of the n-<NUM> polyunsaturated fatty acid to the n-<NUM> polyunsaturated fatty acid is <NUM> or greater, for example, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, or <NUM> or greater. In the present specification, the n-<NUM> polyunsaturated fatty acid is a polyunsaturated fatty acid having <NUM> or more carbon atoms and having two or more carbon-carbon double bonds, and having the first double bond between the third and the fourth carbon atoms, numbering from the carbon of methyl group in the terminal of fatty acid chain. Examples include α-linolenic acid (C <NUM>:<NUM> n-<NUM>), octadecatetraenoic acid (C18:<NUM> n-<NUM>), eicosatetraenoic acid (C20:<NUM> n-<NUM>), eicosapentaenoic acid (C20:<NUM> n-<NUM>), docosapentaenoic acid (C22:<NUM> n-<NUM>), and docosahexaenoic acid (C22:<NUM> n-<NUM>). In addition, the n-<NUM> polyunsaturated fatty acid is a polyunsaturated fatty acid having <NUM> or more carbon atoms and having two or more carbon-carbon double bonds, and having the first double bond between the sixth and the seventh carbon atoms, numbering from the carbon of methyl group in the terminal of fatty acid chain. Examples include linoleic acid (C <NUM>:<NUM> n-<NUM>), and arachidonic acid (C20:<NUM> n-<NUM>). In the present specification, the area ratio of the fatty acid refers to the ratio of the peak area detected by gas chromatography after esterifying the fatty acid in the composition according to AOCS official method Celb-<NUM>. The analytical conditions used for gas chromatography are listed above.

Improving vascular endothelial function refers to improving the function of vascular endothelial cells, for example, improving the function of regulating vasoconstriction and relaxation of vascular walls by secreting vasoactive substances such as nitric oxide (NO) and endothelin. As methods for assessing the function of such vascular endothelial cells (vascular endothelial function), for example, strain-gauged plethysmography, FMD (flow-mediated dilatation), and RH-PAT (reactive hyperemia peripheral arterial tonometry) are known ("<NPL>, The Japanese Circulation Society). In a preferred aspect of the invention, FMD is used for assessing vascular endothelial function. The FMD value (%) is the ratio of the maximum expanded width to the resting vessel diameter and is calculated by the following equation: <MAT>.

The composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention can be used as a composition for improving Flow Mediated Dilation, because the composition can improve the FMD value.

The test in the Examples described below is directed to healthy individuals. Improving FMD value in the test is not meant to treat diseases such as arteriosclerosis, but may further encourage normal vascular endothelial function or improve the condition of vascular endothelial disorders, and thereby reduce the risk of suffering from a disease due to vascular endothelial disorders. Thus, in one aspect, a composition for improving vascular endothelial function is a composition for reducing the possibility of suffering from a disease due to vascular endothelial disorders. Here, vascular endothelial disorders refer to a condition in which arterial sclerosis has not been achieved, but the vascular endothelial function is reduced. For example, even if no atherosclerotic plaque is found in the blood vessel, it is suspected to be vascular endothelial disorder when the FMD value is less than <NUM>%. The disease due to vascular endothelial disorders is hypertension.

The subject for administering the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention is a mammal, and preferably a human. The age of the subject to be administered is not particularly limited as long as the effect of the present invention can be achieved. In one aspect, the age of the subject to be administered is <NUM> or greater, for example, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, and <NUM> or greater.

When the monounsaturated fatty acid having <NUM> or more carbon atoms, a salt thereof, or an ester thereof is administered to a subject having a FMD value of less than <NUM>%, the effect of improving the FMD value may be more significant. Thus, in one aspect, the subject for administering the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention has an FMD value of less than <NUM>%. For example, the age of the subject to be administered may be <NUM> or greater, for example, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, <NUM> or greater, and <NUM> or greater and the subject may have an FMD value of less than <NUM>%.

The composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention can be prepared in a form suitable for a pharmaceutical composition, a food composition (for example, functional food products, health food products, and supplements), various solid formulations such as a granule (including a dry syrup), a capsule (soft capsule or hard capsule), a tablet (including a chewable tablet), a powder (a powder formulation), and a pill, or liquid formulations such as oral liquid formulations (including a liquid, a suspension, and a syrup). For example, the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention can be formulated as a soft capsule in which a purified fish oil is filled into a gelatin coating.

Examples of additives that help with formulation include excipients, lubricants, binders, disintegrating agents, fluidization agents, dispersing agents, wetting agents, preservatives, thickening agents, pH adjusting agents, colorants, corrigents, surfactants, and solubilisation agents. Additionally, prepared as a liquid formulation, thickening agents such as pectin, xanthan gum, guar gum, and the like can be compounded. Moreover, the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention can be formed into a coated tablet formulation by using a coating agent, or be formed into a paste-like gelatin formulation. Furthermore, even when preparing the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention in other forms, it is sufficient to follow known methods.

The composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention can take the form of a food composition. In an embodiment of the present invention, the food composition means general food products including beverages. The food composition includes foods for specified health uses and foods with nutrient function defined in the health-promoting food regulations of the Consumer Affairs Agency in addition to general food products including health food products such as supplements. For example, functional food products are provided that have an indication that they reduce the risk of suffering from hypertension. For example, fish oil-containing food products can be provided as are. The food composition according to an embodiment of the present invention also includes a food material for reducing the risk of suffering from hypertension by adding, mixing or applying to other food products. In addition to food products, it can also be provided as animal feeds or the like.

When the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention is in the form of a food product, the food product is not particularly limited. The food product may be beverages, confectionaries, breads, or soups. Examples include common retort foods, frozen food, ready-to-drink (such as noodles), cans, sausage, cookies, biscuits, cereal bars, crackers, snacks (such as potato chips), pastry, cakes, pies, candies, chewing gum (including pellets and sticks), jellies, soups, ices, dressings, yogurts, or the like, supplements in the form of a tablet, a capsule, and an emulsion, and soft drinks. The method for manufacturing these food products is not particularly limited as long as the effect of the present invention is not impaired, and may be according to the method used by the person skilled in the art for each food products.

It is within the scope of the invention to display the benefits according to an embodiment of the composition for reducing the risk of suffering from hypertension according to an embodiment of the present invention in packaging containers, product instructions, and brochures and to sell the products according to the present invention. It is also within the scope of the present invention to display the benefits of the present invention on television, Internet websites, brochures, newspaper, magazines, and to advertise and sell the products according to an embodiment of the present invention.

The amount of the ingredient selected from a monounsaturated fatty acid having <NUM> or more carbon atoms, a salt thereof, and an ester thereof ingested by the subject in an embodiment of the present invention is not particularly limited. For example, the ingredient is ingested in an amount equal to or greater than the effective amount for obtaining the desired effect. Here, the effective amount for obtaining the desired effect refers to the amount required to reduce the risk of suffering from hypertension. For example, in the case of an adult, depending on the conditions such as age, weight, and health conditions of the subject, <NUM>/kg weight/day or greater, for example, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, <NUM>/kg weight/day or greater, or <NUM>/kg weight/day or greater of the active ingredient based on the monounsaturated fatty acid having <NUM> or more carbon atoms can be ingested for <NUM> weeks or more, for example, <NUM> weeks or more, <NUM> weeks or more, <NUM> weeks or more, <NUM> weeks or more, <NUM> weeks or more, <NUM> weeks or more, <NUM> weeks or more, <NUM> weeks or more. In addition, since the ingredient selected from a monounsaturated fatty acid having <NUM> or more carbon atoms, a salt thereof, and an ester thereof does not have a strong side effect, there is no restriction on the daily amount of ingestion.

The present invention is described specifically below by citing Examples, but the present invention is not limited to these Examples.

Note that in the Examples, valueS represented in % are wt% unless otherwise indicated.

Fatty acid compositions of purified saury oil in the capsule and the can of baked saury with salt are shown in Table <NUM>. The fatty acid composition of the purified saury oil was calculated by the value measured by gas chromatography after esterifying the ingredient in the composition according to AOCS official method Celb-<NUM>. The fatty acid composition of the can of baked saury with salt is the result of analysis by the Japan Food Research Laboratories. The analytical conditions for gas chromatography according to AOCS official method Celb-<NUM> are listed below.

The general ingredient table and fatty acid contents of the capsule of saury oil are shown in Table <NUM>. The general ingredient table and fatty acid contents of the can of baked saury with salt are shown in Table <NUM>. Analytical results (acid value, peroxide value, p-anisidine value, lipid composition) of the purified saury oil in the capsules are shown in Table <NUM>.

Fatty acid composition and content in solid.

b) Subjects: <NUM> healthy adult individuals including students of the Tokushima University having age of <NUM> or more were divided two groups (a capsule ingestion group and a can ingestion group). As a capsule ingestion group, <NUM> individuals having age of <NUM> in average (average weight: <NUM> (before ingestion) and <NUM> (after ingestion)) participated. As a can ingestion group, <NUM> individuals having age of <NUM> in average (average weight: <NUM> (before ingestion) and <NUM> (after ingestion)) participated (Tables <NUM>-<NUM> and <NUM>-<NUM>). During the study, one individual of the capsule ingestion group stopped the test because neutral fat showed high value, and one individual in the can ingestion group was excluded because of a violation of the intake criteria.

c) Test conditions: the capsule ingestion group ingested <NUM> capsules per day for <NUM> weeks. The can ingestion group ingested at a rate of <NUM> cans per a week for a total of <NUM> weeks. The <NUM> capsules contained <NUM> of saury oil. The subjects would ingest about <NUM> as LC-MUFA per day. The can of baked saury with salt contained about <NUM> of oils and fats per one can (<NUM>). The subjects would ingest about <NUM> as LC-MUFA per day.

Blood test and biochemistry tests, QOL questionnaires, and vascular endothelial function measurements were taken before the start of the study and at <NUM> weeks after ingestion.

Blood test and biochemistry tests were performed on SRL Corporation.

QOL questionnaires were conducted with VAS (visual analogue scale) for six questionnaires (fasting, swell, fatigue, wakefulness, tasty, and enjoyment). Subjects answered their current states in the rate of <NUM> to <NUM> for each questionnaire. For example, for wakefulness, it is a relative quantified evaluation of the mood upon wake-up of the subject in which a condition in which the subject can wake up comfortably in the morning is taken as <NUM>, and a condition in which the subject cannot wake up comfortably at all is taken as <NUM>. Higher values indicate the improvement of awaking.

Vascular endothelial function was evaluated by measuring FMD values using a Flow Mediated Dilation (FMD) test device UNEX EF (manufactured by UNEX corporation). The FMD Value (%) was calculated by maximum expanded width (mm) / resting vessel diameter (mm) x <NUM>.

Statistical software Graphpad Prism (from MDF Co. ) was used for statistical processing. Multiple groups of tests were performed using a one-way variance analysis method, and a Tukey 's multiple comparisons test was used for the multiple comparison test. For intergroup comparison between two groups, unpaired t-test which is an independent comparison of two groups was used. For intragroup comparison, the paired t-test which is a dependent comparison of two groups was used.

As shown in Table <NUM> and <FIG>, significant improvement of FMD values was observed for both groups compared to before ingestion and at <NUM> weeks after the start of ingestion of the capsule or the can. The improvement in FMD value of about <NUM>% was observed in the capsule ingestion group. The improvement in FMD value of about <NUM>% was observed in the can ingestion group.

In addition, for nine subjects in which the increase of FMD value was observed, the FMD value was measured again by providing a washout period of <NUM> weeks after the end of ingestion. As a result, as illustrated in <FIG>, a tendency was observed in which the FMD value declined after the washout period. This confirmed that the ingestion of fish oil likely increased the FMD value.

In addition, when data was analyzed for subjects having FMD values of less than <NUM>% before ingestion and suspected vascular endothelial disorder, both groups tended to increase FMD values after ingestion. This suggests that the ingestion of saury oil may not only increase vascular endothelial function in subjects with FMD values within normal range, but also improve vascular endothelial disorders in subjects with FMD values outside of normal range. Also, since the saury oil is enriched in LC-MUFA, the possibility that LC-MUFA influences vascular endothelium and improves vascular endothelial function was shown.

As shown in Tables <NUM>-<NUM> and <NUM>-<NUM> and <FIG>, awaking was improved in the capsule group.

Body composition evaluations (weight, body fat, fat removal mass, muscle mass, body moisture content, and BMI) were measured using a Dual Frequency Total Body Composition Analyzer (DC - <NUM>, available from TANITA corporation). As shown in Tables <NUM>-<NUM> and <NUM>-<NUM> and <FIG>, the capsule group significantly reduced body fat percentage.

No abnormalities were observed in both groups in the blood test (Table <NUM>). Blood biochemistry was found to reduce the neutral fat (TG) concentration after ingestion in the capsule group (Table <NUM>).

Each value in the table represents an average ± standard deviation.

(a) Test Food Product: the capsule of saury oil contained <NUM> of fish oils derived from saury containing about <NUM>% of LC-MUFA to all fatty acids. The capsule of blended oil contained <NUM> of mixed oil containing tuna oil and purified olive oil at the weight ratio of <NUM>:<NUM> (containing LC-MUFA to all fatty acids in the ratio of about <NUM>%). The total of EPA + DPA + DHA in the fatty acid composition of the capsule of saury oil and the capsule of blended oil was <NUM>% and <NUM>%, respectively, which were approximately equivalent.

The fatty acid compositions in the capsule of saury oil and the capsule of blended oil are shown in Table <NUM>. The fatty acid composition was calculated by the value measured by gas chromatography after esterifying the ingredient in the composition according to AOCS official method Celb-<NUM>.

(b) Subjects: <NUM> healthy adult individuals including students of the Tokushima University having age of <NUM> or more were divided two groups (a saury oil capsule ingestion group and a blended oil capsule ingestion group). As the saury oil capsule ingestion group, <NUM> individuals of age <NUM> on average (average weight: <NUM> (before ingestion) and <NUM> (after ingestion)) participated. As the blended oil capsule ingestion group, <NUM> individuals of age of <NUM> on average (average weight: <NUM> (before ingestion) and <NUM> (after ingestion)) participated (Table <NUM>).

(c) Test conditions: the subjects ingested <NUM> capsules per day for <NUM> weeks. The <NUM> capsules of saury oil contained <NUM> of saury oil. The subjects would ingest about <NUM> of LC-MUFA and about <NUM> of n-<NUM> polyunsaturated fatty acids (EPA + DPA + DHA) per day. The <NUM> capsules of blended oil contained <NUM> of tuna oil and <NUM> of purified olive oil. The subjects would ingest about <NUM> of LC-MUFA per day and about <NUM> of n-<NUM> polyunsaturated fatty acids (EPA + DPA + DHA) per day. Thus, although the amount of ingestion of LC-MUFA in each capsule group was different, the amount of ingestion of n-<NUM> polyunsaturated fatty acid (EPA + DPA + DHA) would be about the same.

Vascular endothelial function measurements were taken before the start of the study and at <NUM> weeks after ingestion. Vascular endothelial function was evaluated by measuring FMD values using a Flow Mediated Dilation (FMD) test device UNEX EF (manufactured by UNEX corporation). The FMD Value (%) was calculated by maximum expanded width (mm) / resting vessel diameter (mm) x <NUM>.

Statistical software Graphpad Prism (from MDF Co. ) was used for statistical processing. Multiple groups of tests were performed using a one-way variance analysis method, and a Tukey 's multiple comparisons test was used for the multiple comparison test. For intergroup comparison between two groups, unpaired t-test which is an independent comparison of two groups was used. For intragroup comparison, paired t-test which is a dependent comparison of two groups was used.

As shown in Table <NUM> and <FIG>, in each group, the improvement of FMD values was observed compared to before ingestion at <NUM> weeks after the start of ingestion of the capsule. An improvement in FMD value of about <NUM>% was observed in the saury oil capsule ingestion group. An improvement in FMD value of about <NUM>% was observed in the blended oil capsule ingestion group. Since the amount of n-<NUM> polyunsaturated fatty acid was the same in each capsule, the possibility of encouraging vascular endothelial function by the action of LC-MUFA was shown.

Claim 1:
A composition for use in the reduction of the risk of suffering from hypertension comprising
an ingredient selected from monounsaturated fatty acids having <NUM> or more carbon atoms, salts thereof and esters thereof, as active ingredient,
wherein
the ratio of monounsaturated fatty acid having <NUM> or more carbon atoms to total fatty acids in the composition is <NUM> wt% or greater, and
the active ingredient is derived from a fish oil.