JP2019127439A - Supplement comprising morus alba leaves - Google Patents
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Abstract
Description
本発明は、桑葉を含む、血圧又はＢＭＩの高めな対象に対する、血圧降下、体重低減、ＬＤＬ−コレステロール低減、整腸、肌状態改善のため、又は桑葉を含む、血糖値の高めな方を対象とした、空腹時血糖値及び/又はインスリンの低下、及び糖尿病予防のための、サプリメントに関する。 The present invention relates to blood pressure reduction, body weight reduction, LDL-cholesterol reduction, intestinal regulation, improvement of skin condition, or high blood glucose level improvement, including lupus, for subjects with high blood pressure or BMI, including mulberry leaves. The present invention relates to a supplement for lowering fasting blood glucose level and / or insulin and preventing diabetes.
メタボリックシンドロームとは、内臓脂肪型肥満（内臓肥満・腹部肥満）に高血糖・高血圧・脂質異常症のうち２つ以上の症状が一度に出ている状態をいう。脂質異常症は、血液中に含まれる脂質が過剰、もしくは不足している状態を指す。高血糖や高血圧はそれぞれ単独でもリスクを高める要因であるが、これらが多数重積すると相乗的に動脈硬化性疾患の発生頻度が高まるため、メタボリックシンドロームの改善又は予防が求められている。 Metabolic syndrome is a condition in which visceral fat type obesity (visceral obesity, abdominal obesity) and two or more symptoms of hyperglycemia, hypertension and dyslipidaemia appear at a time. Dyslipidemia refers to a condition in which lipid contained in blood is excessive or insufficient. Although hyperglycemia and hypertension alone are factors that increase the risk alone, when a large number of these are piled up, the frequency of occurrence of arteriosclerosis increases synergistically, so improvement or prevention of metabolic syndrome is required.
桑葉は、糖尿病の治療や血圧抑制に薬効を示すといわれている。しかし、国立健康・栄養研究所の「健康食品」の安全性・有効性情報の素材情報データベースの「クワ」の項（非特許文献１）には、「クワは温暖地方のクワ科の植物で、俗に、「血糖値の上昇を抑える」「コレステロールを下げる」などと言われているが、ヒトでの有効性については信頼できるデータが見当たらない。」と記載されているとおり、ヒトでの有効性については知られていない。また、局方の生薬として用いられるのはクワの根皮（桑白皮）である。 Mulberry leaves are said to show medicinal effects in the treatment of diabetes and blood pressure suppression. However, in the "Kuwa" section (non-patent document 1) of the material information database of safety and efficacy information of "health food" of the National Institute of Health and Nutrition, "Kuwa is a plant of the mulberry family in the temperate region. In general, it is said that “suppresses the increase in blood sugar level” and “lowers cholesterol”, but there is no reliable data on its effectiveness in humans. ”Is not known for its effectiveness in humans. Also, mulberry root bark (mulberry white bark) is used as a herbal medicine.
特許文献１には、細断した桑葉を蒸煮した後、乾燥し、これを焙煎して桑茶を得ること、および、当該桑茶を微細粉末とした桑抹茶は、そのまま水等に懸濁させて飲用したり、食品素材として各種食品等に配合できることが記載されている。しかし、桑葉のヒトに対する有効性については記載されていない。 In Patent Document 1, after steaming minced persimmon leaf, it is dried and roasted to obtain persimmon tea, and persimmon green tea obtained by making the persimmon tea into fine powder is used as it is in water etc. It is described that it can be drunk and drunk, or can be blended in various foods as a food material. However, the effectiveness of mulberry leaves for humans is not described.
特許文献２には、桑の葉に嫌気処理と好気処理を交互に繰り返した後、最後に嫌気処理を施すことにより、血圧降下作用、中性脂肪抑制作用など様々な生理活性作用を有するＧＡＢＡ含量の高い桑の葉を製造することについて記載されており、上記製造工程において、桑の葉に蒸熱、乾燥、焙煎、粉砕処理等を施してもよいことが記載されている。しかし、桑葉のヒトに対する有効性については記載されていない。 In Patent Document 2, after alternately repeating anaerobic treatment and aerobic treatment on mulberry leaves, GABA treatment having various physiological activities such as blood pressure lowering action, neutral fat suppressing action, and the like by finally performing anaerobic treatment It is described that the mulberry leaf having a high content is produced, and it is described that the mulberry leaf may be subjected to steaming, drying, roasting, grinding treatment and the like in the above-mentioned production process. However, the effectiveness of mulberry leaves for humans is not described.
特許文献３には、桑の葉乾燥粉末を含む呈味の優れたチューインガムが記載されている。しかし、桑葉のヒトに対する有効性については記載されていない。 Patent Document 3 describes a chewing gum excellent in taste containing dry powder of mulberry leaves. However, the effectiveness of mulberry leaves for humans is not described.
特許文献４には、桑の葉の微粉末を摂取することにより、体重低下、血糖値低下、脂肪の固まりの縮小等の効果がみられたことが記載されている。しかし、それらを裏付ける実験方法及び結果は、一切示されておらず、桑葉のヒトに対する有効性について記載されているとはいえない。 Patent Document 4 describes that ingestion of a fine powder of mulberry leaves showed effects such as a decrease in body weight, a decrease in blood sugar level, and a reduction in fat mass. However, the experimental methods and results to support them are not shown at all, and it can not be said that the efficacy of mulberry leaves for humans is described.
特許文献５には、桑の葉粉末を含有するアイスクリーム類について記載されており、当該桑の葉に、血圧降下作用やコレステロール低下作用等の薬理的作用が確認されていることも記載されている。しかし、それらを裏付ける実験方法及び結果は、一切示されておらず、桑葉のヒトに対する有効性について記載されているとはいえない。 Patent Document 5 describes ice creams containing persimmon leaf powder, and it is also described that pharmacological actions such as blood pressure lowering action and cholesterol lowering action are confirmed in the persimmon leaf. There is. However, the experimental methods and results to support them are not shown at all, and it can not be said that the efficacy of mulberry leaves for humans is described.
特許文献６には、高脂血症及び糖尿病の病態動物に桑葉粉末を投与して、当該桑葉粉末によって、中性脂肪（ＴＧ）値の増加や脂肪肝の形成が抑制されることが記載されている。しかし、桑葉のヒトに対する有効性については記載されていない。 In Patent Document 6, mulberry leaf powder is administered to a diseased animal of hyperlipidemia and diabetes, and the increase in neutral fat (TG) value and the formation of fatty liver are suppressed by the mulberry leaf powder. Have been described. However, the effectiveness of mulberry leaves for humans is not described.
非特許文献２には、マウスへの桑葉粉末の投与によって、体重が有意に増加し、血糖値への影響がなかったことが記載されている。また、メタボリックシンドロームモデルを作成することができるウエスタンダイテエット（脂質、糖質を高配合した飼料）に比べて、中性脂肪（ＴＧ）値の増加や脂肪肝の形成が抑制されることが記載されている。しかし、桑葉の健常ヒトに対する有効性については記載されていない。 Non-Patent Document 2 describes that administration of mulberry leaf powder to mice significantly increased body weight and had no effect on blood glucose level. In addition, it is described that the increase in triglyceride (TG) level and the formation of fatty liver are suppressed compared to Western Dieteet (a diet high in lipid and carbohydrate) which can create a metabolic syndrome model. It is done. However, the effectiveness of mulberry leaves on healthy humans is not described.
非特許文献３には、目標体重の維持カロリー量に設定し、桑の葉を健常犬に投与して、体重、体脂肪率、腹囲周囲径のいずれも減少傾向を示したことから、桑の葉の給与により減量につながることが記載されている。しかし、桑葉のヒトに対する有効性については記載されていない。 In Non-Patent Document 3, since the maintenance calorie amount of the target body weight is set, and the persimmon leaf is administered to a healthy dog, all of the body weight, the body fat percentage, and the abdominal circumference diameter show a decreasing tendency. It is described that the salary of leaves leads to weight loss. However, the effectiveness of mulberry leaves for humans is not described.
非特許文献４には、桑葉パウダーを３ヶ月間飲用することによって、耐糖能異常者においては、空腹時血糖の低下、ＨｂＡ１ｃの低下が認められたが、正常血糖値成人においては、空腹時血糖、ＨｂＡ１ｃ及び血液生化学の有意な変化は見られなかったことが記載されている。 Non-patent document 4 shows that fasting blood glucose and HbA1c were decreased in glucose tolerance-impaired persons by drinking mulberry leaf powder for 3 months, but fasting was observed in normal blood glucose level adults. It is described that no significant changes in blood glucose, HbA1c and blood biochemistry were found.
非特許文献５〜７には、桑葉に含まれる１−デオキシノジリマイシン（ＤＮＪ）が整腸作用を有することが記載されている。しかし、摂食を制限しない健常者に対する桑葉粉末の有効性は、記載されていない。 Non-patent documents 5 to 7 describe that 1-deoxynojirimycin (DNJ) contained in mulberry leaves has an intestinal regulation effect. However, the effectiveness of mulberry leaf powder for healthy individuals who do not restrict eating is not described.
健康食品の分野においては、インビトロでの実験や動物実験の条件がヒトにおける摂取条件とは異なっている場合が少なくないことから、ヒト以外での結果をそのままヒトに適用することは困難であり、その効果を証明するためには、臨床試験でのデータが必要とされている。また、通常の摂取量においては、所望の効果が得られないことも少なくない。上記のとおり、桑葉については、ヒトでの有効性については信頼できるデータが見当たらない。 In the field of health foods, in vitro experiments and animal experiment conditions are often different from human intake conditions, so it is difficult to apply non-human results directly to humans, In order to prove its effectiveness, data from clinical trials are needed. In addition, the desired effect is often not obtained with normal intake. As mentioned above, for mulberry leaves, there are no reliable data on human efficacy.
そこで、科学的な裏付けのある、血圧又はＢＭＩの高めな方を対象とした血圧降下、体脂肪低減、ＢＭＩ低減のためのサプリメントの開発が望まれていた。 Therefore, it has been desired to develop supplements for lowering blood pressure, reducing body fat, and reducing BMI for those with higher blood pressure or BMI, which are scientifically supported.
本発明は、血圧又はＢＭＩの高めな方を対象とした、血圧降下、体重低減、ＬＤＬ−コレステロール低減、整腸、肌状態改善、及び血糖値の高めな方を対象とした、空腹時血糖値及び/又はインスリンの低下作用、及び糖尿病予防のためのサプリメントを提供する。 The present invention relates to fasting blood glucose levels for blood pressure lowering, body weight reduction, LDL-cholesterol reduction, intestinal regulation, skin condition improvement, and high blood glucose levels, for those with high blood pressure or BMI. And / or an insulin-lowering action and a supplement for preventing diabetes.
本発明者は、驚くべきことに、桑葉又は桑葉抽出物が、食事・飲酒・運動・睡眠等の生活習慣を変えることなく、血圧又はＢＭＩの高めな方を対象とした、血圧降下、体重低減、ＬＤＬ−コレステロール低減、整腸、肌状態改善の作用、及び血糖値の高めな方を対象とした、空腹時血糖値及び/又はインスリンの低下作用、及び糖尿病予防の作用を有することを見出し、本発明を完成させた。 The present inventors have surprisingly found that mulberry leaves or mulberry leaf extracts are intended for those with higher blood pressure or BMI without changing their lifestyle habits such as eating, drinking, exercising, sleeping, etc. Have a fasting blood glucose level and / or insulin lowering action, and a diabetes preventing action for weight reduction, LDL-cholesterol reduction, intestinal regulation, skin condition improving action and higher blood glucose level The present invention has been completed.
すなわち、本発明は、以下に関する：
［１］桑葉を含む、血圧又はＢＭＩの高めな方を対象とした、血圧降下のためのサプリメント、
［２］桑葉を含む、血圧又はＢＭＩの高めな方を対象とした、体重低減のためのサプリメント、
［３］桑葉を含む、血圧又はＢＭＩの高めな方を対象とした、ＬＤＬ−コレステロール低減のためのサプリメント、
［４］桑葉を含む、血圧又はＢＭＩの高めな方を対象とした、整腸のためのサプリメント、
［５］桑葉を含む、血圧又はＢＭＩの高めな方を対象とした、肌状態改善のためのサプリメント、
［６］血圧又はＢＭＩの高めな方が、収縮期血圧が１３０〜１５９ｍｍＨｇであるか、又は、拡張期血圧が８５〜９９ｍｍＨｇであるか、又は、ＢＭＩが２３〜３０ｋｇ／ｍ２である、［１］〜［５］のいずれかに記載のサプリメント、
［７］桑葉を含む、血糖値の高めな方を対象とした、空腹時血糖値及び/又はインスリンの低下のためのサプリメント、
［８］桑葉を含む、血糖値の高めな方を対象とした、糖尿病予防のためのサプリメント、
［９］血糖値の高めの方が、空腹時血糖値が８０〜１０９ｍｇ／ｄｌである、［８］又は［８］に記載のサプリメント。
That is, the present invention relates to the following:
[1] A supplement for lowering blood pressure, intended for persons with elevated blood pressure or BMI, including mulberry leaves,
[2] A weight-loss supplement intended for persons with elevated blood pressure or BMI, including mulberry leaves,
[3] Supplements for reducing LDL-cholesterol for those with higher blood pressure or BMI, including mulberry leaves,
[4] Supplements for intestinal regulation, intended for persons with elevated blood pressure or BMI, including mulberry leaves,
[5] Supplements for improving skin condition for those with high blood pressure or BMI, including mulberry leaves,
[6] The higher the blood pressure or BMI, the systolic blood pressure is 130 to 159 mmHg, or the diastolic blood pressure is 85 to 99 mmHg, or the BMI is 23 to 30 kg / m 2 . 1] to the supplement according to any one of [5],
[7] Supplements for lowering fasting blood glucose level and / or insulin, intended for persons with high blood glucose levels, including mulberry leaves
[8] Supplements for diabetes prevention for those with high blood sugar levels, including mulberry leaves,
[9] The supplement according to [8] or [8], wherein the higher the blood glucose level, the fasting blood glucose level is 80 to 109 mg / dl.
本発明は、桑葉を含む、血圧又はＢＭＩの高めな対象に対する、血圧降下、体重低減、ＬＤＬ−コレステロール低減、整腸、肌状態改善、及び血糖値の高めな方を対象とした、空腹時血糖値及び/又はインスリンの低下作用、及び糖尿病予防のために有用である。 The present invention relates to fasting for subjects with high blood pressure or BMI, including mulberry leaves, for those with lower blood pressure, weight reduction, LDL-cholesterol reduction, intestinal regulation, skin condition improvement, and higher blood glucose levels. It is useful for lowering blood glucose level and / or insulin and preventing diabetes.
本発明においては、クワ科（Moraceae）に属する植物、たとえば、クワ（M. nigra）、カラグワ（Morus alba L.）、ヤマグワ（M.bombycis KOIDZ.）、マグワ（M. latifolia POIRET.）等を用いることができる。好ましくは、桑植物の葉部を用いる。桑葉は、乾燥葉でも生葉でもよい。桑葉は、粉末の形態であることができる。 In the present invention, plants belonging to the family Moraceae, for example, mulberry (M. nigra), karagua (Morus alba L.), yamaguwa (M.bombycis KOIDZ.), Magwa (M. latifolia POIRET.), Etc. It can be used. Preferably, the leaves of the moss plants are used. The mulberry leaves may be dry leaves or fresh leaves. The mulberry leaves can be in the form of a powder.
本発明の桑葉は、その抽出物として用いることができる。抽出は、水を用いることができる。 The mulberry leaves of the present invention can be used as an extract thereof. Extraction can use water.
抽出方法は、桑葉１重量部に対し抽出溶媒を好適には８〜１００重量部加え抽出する。この場合、抽出温度は、５０〜１００℃が好ましく、７０〜９５℃が特に好ましい。また、抽出時間は、好適には１〜１０時間、より好ましくは２〜５時間が適当であり、抽出時に軽く攪拌をしてもよい。 The extraction method is preferably performed by adding 8 to 100 parts by weight of an extraction solvent to 1 part by weight of mulberry leaves. In this case, the extraction temperature is preferably 50 to 100 ° C, particularly preferably 70 to 95 ° C. The extraction time is preferably 1 to 10 hours, more preferably 2 to 5 hours, and light agitation may be carried out at the time of extraction.
本発明の桑葉抽出物は、色素や臭いを有する成分を取り除くため、活性炭、骨炭、水酸化カルシウム等で処理してもよい。 The mulberry leaf extract of the present invention may be treated with activated carbon, bone charcoal, calcium hydroxide or the like in order to remove the pigment and odorous components.
本発明の桑葉抽出物は、更に、減圧濃縮し、真空乾燥、スプレー乾燥、凍結乾燥を行い、乾燥粉末とすることができる。 The mulberry leaf extract of the present invention can be further concentrated under reduced pressure, vacuum-dried, spray-dried and freeze-dried to form a dry powder.
本発明においては、桑葉又は桑葉抽出物の含有量は、０．００１重量％〜８０重量％、好ましくは０．０１重量％〜６０重量％、より好ましくは０．５重量％〜３０重量％である。 In the present invention, the mulberry leaf or mulberry leaf extract content is 0.001 wt% to 80 wt%, preferably 0.01 wt% to 60 wt%, more preferably 0.5 wt% to 30 wt%. %.
食品の形態としては、麺、パスタ、顆粒、錠果、ゼリー、液体（飲料）などが挙げられる。これら食品は、様々な食品材料を適宜使用して製造することができる。食品材料の具体例は、米、小麦、トウモロコシ、ジャガイモ、スイートポテト、大豆粉、海藻粉、水飴、乳糖、グルコース、果糖、スクロース、マンニトールなどであり、これらを単独または適宜組み合わせて使用することができる。必要に応じて水などの使用により所望の形状にすることができる。さらに、香味料、着色料、甘味料、食用油、ビタミン類などを適宜添加することもできる。 Examples of the form of food include noodles, pasta, granules, tablets, jelly, and liquid (beverage). These foods can be produced by appropriately using various food materials. Specific examples of the food material are rice, wheat, corn, potato, sweet potato, soy flour, seaweed powder, starch syrup, lactose, glucose, fructose, sucrose, mannitol and the like, which may be used alone or in appropriate combination. it can. If necessary, the desired shape can be obtained by using water or the like. Furthermore, flavoring agents, coloring agents, sweetening agents, edible oils, vitamins and the like can be added as appropriate.
また、サプリメントとして、錠剤、カプセル剤、顆粒剤、ゼリー剤、ドリンク剤などの形態も挙げられる。これらは、通常のサプリメント製造における添加剤を使用して製造することができる。さらに、これらサプリメントは、例えばビタミン類などの他の有効成分を含有することもできる。また、甘味料、香味料、着色料、酸化防止剤などの添加剤を単独または適宜組み合わせて使用することもできる。これらサプリメントは、当業者に周知の方法で製造することができる。 Moreover, forms, such as a tablet, a capsule, a granule, a jelly agent, and a drink, are also mentioned as a supplement. These can be manufactured using additives in normal supplement manufacturing. Furthermore, these supplements can also contain other active ingredients such as vitamins. In addition, additives such as sweeteners, flavoring agents, coloring agents, and antioxidants may be used alone or in appropriate combination. These supplements can be produced by methods well known to those skilled in the art.
添加剤の具体例としては、ラクトース、デキストリン、スクロース、マンニトール、コーンスターチ、ソルビトール、結晶性セルロース、ポリビニルピロリドンなどが挙げられ、これらを単独または適宜組み合わせて使用することができる。 Specific examples of the additive include lactose, dextrin, sucrose, mannitol, corn starch, sorbitol, crystalline cellulose, polyvinyl pyrrolidone and the like, and these can be used alone or in combination as appropriate.
本発明の桑葉又は桑葉抽出物の成人による摂取量は、１日あたり１０ｍｇ〜５ｇ、好ましくは２ｇであるが、摂取する人の状態に応じて摂取量を増減することができる。 The intake of the mulberry leaf or the mulberry leaf extract of the present invention is 10 mg to 5 g, preferably 2 g per day, but the intake amount can be increased or decreased depending on the condition of the person who takes it.
本発明の桑葉は、粉末として製剤することができる。粉末は、１ｇを１包として、１日２回、たとえば、昼食前と夕食前に、１回１包を１５０〜１８０ｍＬの水又はぬるま湯に溶かして摂取することができる。 The mulberry leaves of the present invention can be formulated as a powder. The powder can be taken up in a package of 1 g twice daily, for example, by dissolving one package in 150 to 180 mL of water or lukewarm water before lunch and dinner.
本発明において、「血圧又はＢＭＩの高めの方」とは、収縮期血圧が１３０〜１５９ｍｍＨｇであるか、又は、拡張期血圧が８５〜９９ｍｍＨｇであるか、又は、ＢＭＩが２３〜３０ｋｇ／ｍ２である者をいう。年齢は、好ましくは、２０〜６４歳であり、性別は不問である。 In the present invention, “the higher blood pressure or BMI” means that the systolic blood pressure is 130 to 159 mmHg, the diastolic blood pressure is 85 to 99 mmHg, or the BMI is 23 to 30 kg / m 2. The person who is The age is preferably 20 to 64 years, and the gender is not questioned.
本発明で中性脂肪とは、血中に含まれるトリグリセリドをいう。 In the present invention, neutral fat refers to triglyceride contained in blood.
ＬＤＬコレステロール（ｌｏｗ ｄｅｎｓｉｔｙ ｌｉｐｏｐｒｏｔｅｉｎ ｃｈｏｌｅｓｔｅｒｏｌ）は、俗に、悪玉コレステロールとも呼ばれ、心血管疾患のリスクファクターとされている。 LDL cholesterol (low density lipoprotein cholesterol) is also commonly referred to as bad cholesterol and is considered to be a risk factor for cardiovascular disease.
ＢＭＩ（Ｂｏｄｙ Ｍａｓｓ Ｉｎｄｅｘ）は、体重と身長の関係から算出される、ヒトの肥満度を表す体格指数（体重（ｋｇ）／身長（ｍ）２）である。 BMI (Body Mass Index) is a body mass index (body weight (kg) / height (m) 2 ) that represents the degree of human obesity calculated from the relationship between body weight and height.
血圧は、動脈の血圧のことであり、心臓の収縮期と拡張期の血圧をいい、それぞれ収縮期血圧（または最高血圧）、拡張期血圧（または最低血圧）と呼ぶ。 Blood pressure refers to arterial blood pressure and refers to systolic and diastolic blood pressure of the heart, which are called systolic blood pressure (or systolic blood pressure) and diastolic blood pressure (or diastolic blood pressure), respectively.
整腸とは、おなかの調子を整えることを意味する。たとえば、便通回数、便の性状（形状、色、におい）、排便後の感覚の改善があげられる。 Adjusting the bowel means adjusting the tummy. For example, the number of bowel movements, the nature of the stool (shape, color, smell), and improvement of feeling after defecation can be mentioned.
肌状態とは、たとえば、かゆみ、潤い、乾燥、しっとり感、はりや弾力、柔らかさ、透明感、ツヤ、スベスベ感、キメ、総合的な肌の感じが挙げられる。 The skin condition includes, for example, itching, moistness, dryness, moistness, firmness, elasticity, softness, transparency, gloss, slippery feeling, texture, and synthetic skin feeling.
糖尿病の予防とは、血糖値の低下、インスリン濃度の低下、ＨｂＡ１ｃ値の低下が挙げられる。 Diabetes prevention includes a decrease in blood glucose level, a decrease in insulin concentration, and a decrease in HbA1c value.
糖尿病の診断においては、正常域は、空腹時血糖値では１１０ｍｇ／ｄｌ未満であり、７５ｇ経口糖負荷試験２時間値では１４０ｍｇ／ｄｌ未満である。本発明において、「血糖値の高めの方」とは、空腹時血糖値が８０〜１０９ｍｇ／ｄｌである者をいう。年齢は、好ましくは、２０〜６４歳であり、性別は不問である。 In the diagnosis of diabetes, the normal range is less than 110 mg / dl for fasting blood glucose levels and less than 140 mg / dl for 2 hour values for 75 g oral glucose tolerance test. In the present invention, the “higher blood glucose level” refers to a person having a fasting blood glucose level of 80 to 109 mg / dl. The age is preferably 20 to 64 years, and the gender is not questioned.
桑葉１ｋｇ（乾燥重量）を蒸熱温度５０℃で、３〜１０分間蒸し、放熱後、６０〜７０℃で乾燥させた。乾燥した桑葉を焙煎し、粉末にした。 1 kg of mulberry leaf (dry weight) was steamed at a steaming temperature of 50 ° C. for 3 to 10 minutes, and after heat release, it was dried at 60 to 70 ° C. The dried mulberry leaves were roasted and powdered.
被験者人数は、３０名であった。選択基準は、以下のとおりである。
（１）年齢 ２０歳以上６４歳以下の男女
（２）血圧 収縮期血圧が１３０〜１５９ｍｍＨｇであるか、又は、拡張期血圧が８０〜９９ｍｍＨｇであるか、又は、ＢＭＩが２３〜３０ｋｇ／ｍ２である
The number of subjects was 30. The selection criteria are as follows:
(1) Age 20 to 64 years old (2) Blood pressure Systolic blood pressure is 130 to 159 mmHg, Diastolic blood pressure is 80 to 99 mmHg, or BMI is 23 to 30 kg / m 2 Is
なお、桑葉の有効性を判断するために、以下の者を対象者から除外した。
（１）桑茶を週３回以上摂取している者
（２）事前検査時に減量中の者
（３）体脂肪や血圧に影響を及ぼす可能性のある医薬品や健康食品（特に特定保健用食品、機能性表示食品）、サプリメント等を服用／使用／摂取している者
（４）生活習慣アンケートの回答から、被験者として不適当と判断された者
（５）研究に関連してアレルギー発症のおそれがある者
（６）常時投薬が必要な疾患がある者、投薬治療を必要とした重篤な疾患既往歴のある者
（７）摂取開始前の身体測定値、理学検査値および臨床検査値に、基準範囲から著しく外れた値がみられる者
（８）本研究開始時に他の臨床研究に参加している者
（９）研究期間中に妊娠、授乳の予定がある者
（10）その他、実施医師責任者が被験者として不適当と判断した者
In order to judge the effectiveness of mulberry leaves, the following persons were excluded from the subjects.
(1) Those who have taken mulberry tea three or more times a week (2) Those who are losing weight at the time of prior examination (3) Drugs and health foods that may affect body fat and blood pressure (especially foods for specified health use) , Functional indication food), supplements, etc. (4) those who are judged to be inappropriate as subjects from the answers to lifestyle questionnaires (5) who may develop allergies in connection with research (6) Persons with diseases that require constant medication, persons with a history of serious illness requiring medication (7) Physical measurements, physical examination values and clinical laboratory values before ingestion , Those whose value significantly deviates from the reference range (8) Those who participate in other clinical studies at the start of this study (9) Those who plan to pregnancy or lactation during the study period (10) Others, Conducted A person who is determined to be inappropriate as a subject by the physician in charge
また、被験者に以下の制限事項をもうけた。
（１）研究期間中は研究参加前からの食事・飲酒・運動・睡眠等の生活習慣を極力変えない。
（２）研究期間中は日常範囲を大きく逸脱する過度な運動、節食や過食を制限するよう指導する。
（３）摂取期間中、研究食品を毎日規定量摂取し、日誌を毎日記録する。
In addition, the subjects were subject to the following restrictions.
(1) During the study period, lifestyle habits such as eating, drinking, exercise and sleeping before participating in the study are not changed as much as possible.
(2) Instruct students to limit excessive exercise, eating habits and overeating that greatly deviate from the daily range during the research period.
(3) During the intake period, take a prescribed amount of research food daily, and keep a daily log.
被験者３０人に、乾燥桑葉１０００ｍｇ／包を、一日２回、昼食前と夕食前に、１５０〜１８０ｍＬの水又はぬるま湯に溶かして摂取させた。摂取期間は１２週間とした。 Thirty test subjects were allowed to take 1000 mg / bag of dried mulberry leaf dissolved in 150 to 180 mL of water or lukewarm water twice a day before lunch and before dinner. The intake period was 12 weeks.
本発明の桑葉を１２週間摂取した後、血圧、ＢＭＩ、腹部脂肪面積（内臓脂肪面積、皮下脂肪面積）、ＬＤＬ−コレステロール、中性脂肪、便通状況（便通回数、便性状）、肌状態、血糖、インスリン、及びＨｂＡ１ｃについて、桑葉の有効性を評価した。 Blood pressure, BMI, abdominal fat area (visceral fat area, subcutaneous fat area), LDL-cholesterol, neutral fat, stool status (number of stools, stool characteristics), skin condition, after ingestion of mulberry leaves of the present invention for 12 weeks The effectiveness of mulberry leaves was evaluated for blood glucose, insulin, and HbA1c.
その結果を以下に示す。
数値は、平均値±標準誤差である。被験者は、３０名である。便通回数は、前観察期間の数値であり、便性状（便の形状、便の色、便のにおい、排便後の感覚）は、摂取前検査の数値である。前観察期間又は摂取前検査との比較は、Ｗｉｌｃｏｘｏｎの符号順位検定でおこなった。＊＊は、ｐ＜０．０１であり、＊は、ｐ＜０．０５である。
The numerical value is an average value ± standard error. There are 30 subjects. The number of stools is a numerical value during the pre-observation period, and the stool quality (form of stool, color of stool, odor of stool, feeling after defecation) is a numerical value of inspection before intake. Comparison with pre-observation period or pre-intake test was performed by the Wilcoxon signed rank test. ** is p <0.01, and * is p <0.05.
数値は、平均値±標準誤差である。被験者は、３０名である。脈拍数は、事前の数値であり、体重及び腹囲は、摂取前検査の数値である。測定値の事前検査又は摂取前検査との比較は、１標本ｔ検定でおこなった。＊＊は、ｐ＜０．０１であり、＊は、ｐ＜０．０５である。
The numerical value is an average value ± standard error. There are 30 subjects. The pulse rate is a prior figure, and the weight and abdominal circumference are the figures of the preintake examination. Comparison of the measured value with the pre-test or pre-intake test was performed by 1-sample t-test. ** is p <0.01, and * is p <0.05.
上記のとおり、本発明のサプリメントは、桑茶の摂取習慣がなく、かつ、体脂肪や血圧に影響を及ぼす可能性のある医薬品や健康食品、サプリメント等を摂取していない、血圧又はＢＭＩの高めな対象に対して、従前の食事・飲酒・運動・睡眠等の生活習慣を変えることなく、血圧降下、体重低減、ＬＤＬ−コレステロール低減、整腸、肌状態改善の効果を示した。また、本発明のサプリメントは、桑茶の摂取習慣がなく、かつ、体脂肪や血圧に影響を及ぼす可能性のある医薬品や健康食品、サプリメント等を摂取していない、血糖値の高めな対象に対して、従前の食事・飲酒・運動・睡眠等の生活習慣を変えることなく、血糖値、及びインスリンの濃度の低下、及び糖尿病予防の効果を示した。健常ヒトでの有効性については知られていないことから、本発明の効果は当業者といえども予測することができない格別なものである。 As described above, the supplement of the present invention does not have the habit of taking green tea, and does not take medicines, health foods, supplements, etc. that may affect body fat and blood pressure, and increases blood pressure or BMI. Showed the effects of blood pressure reduction, weight reduction, LDL-cholesterol reduction, intestinal regulation, and skin condition improvement, without changing lifestyle habits such as conventional diet, alcohol drinking, exercise and sleep. In addition, the supplement of the present invention is a subject with high blood sugar level, which does not have a habit of taking green tea and does not take medicines, health foods, supplements, etc. that may affect body fat and blood pressure. On the other hand, the blood glucose level and insulin concentration were reduced and diabetes was prevented without changing the conventional lifestyle such as eating, drinking, exercising and sleeping. The efficacy of the present invention is exceptional, even one skilled in the art can not predict because its efficacy in healthy humans is unknown.
本発明のサプリメントは、血圧又はＢＭＩの高めな対象に対する、血圧降下、体重低減、ＬＤＬ−コレステロール低減、整腸、肌状態改善、及び糖尿病予防、及び血糖値の高めな対象に対する、血糖値、インスリンの濃度の低下、及び糖尿病予防のために有用である。 The supplement of the present invention is for blood pressure or BMI high subjects, blood pressure reduction, body weight reduction, LDL-cholesterol reduction, intestinal regulation, skin condition improvement, and diabetes prevention, and for subjects with high blood sugar level, blood glucose, insulin It is useful for lowering the concentration of and preventing diabetes.
Claims (9)
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