JP2020005598A - Composition for adjusting wake-up cortisol concentration - Google Patents

Abstract

To provide means for adjusting wake-up cortisol concentration.SOLUTION: The present invention provides a composition for adjusting wake-up cortisol concentration, containing lactoferrin as an active ingredient. The cortisol concentration may be a blood or salivary cortisol concentration. The composition of the present invention can, for example, when administered to a human having a high wake-up cortisol concentration, reduce the concentration, or, when administered to a human having a low wake-up cortisol concentration, increase the concentration. The composition of the present invention may be a food/beverage composition or a pharmaceutical composition.SELECTED DRAWING: None

Description

  The present technology relates to a composition for adjusting the concentration of cortisol at waking up.

  Cortisol is an important hormone secreted by the adrenal cortex. It is also known that cortisol acts on various tissues in the body. Cortisol secretion fluctuates during the day. Blood or salivary cortisol levels generally are lowest after bedtime and gradually increase as one approaches waking up. The cortisol concentration is highest after getting up, and then gradually decreases again as one approaches bedtime.

  There have been several reports on the relationship between cortisol concentration at waking and human status. For example, it has been reported that a human having Asperger's syndrome has low cortisol concentration at waking up (Non-patent Document 1 below). It has also been reported that humans with burnout have a low cortisol concentration at waking (Non-Patent Document 2 below).

Brosnan et al., Psychoneuroendocrinology, (2009) 34, p.1095-1100 Morgan et al., Yale J. Biol. Med., (2002) 75 (4), p.199-205

  Cortisol is an important hormone that acts on various tissues in the body as described above. Therefore, if the cortisol concentration can be adjusted, it is considered to be useful for improvement of human condition. Therefore, an object of the present technology is to provide a new means for adjusting the cortisol concentration.

  The present inventors have found that lactoferrin, which is a milk-derived component, can regulate the wakeful cortisol concentration. That is, the present technology provides the following.

[1] A composition for adjusting the concentration of cortisol at waking up, which comprises lactoferrin as an active ingredient.
[2] The composition according to [1], wherein the composition is for adjusting the concentration of cortisol in blood or saliva.
[3] The composition according to [1] or [2], wherein the composition is administered to a human.
[4] The composition according to any one of [1] to [3], wherein the composition is administered such that a lactoferrin intake is 10 mg or more per day.
[5] The composition according to any one of [1] to [4], wherein the composition is a food or drink composition.
[6] The composition according to any one of [1] to [4], wherein the composition is a pharmaceutical composition.

The compositions of the present technology can regulate cortisol levels upon waking. The composition of the present technology can, for example, lower the concentration when administered to a human having a high wake-up cortisol concentration, or increase the concentration when administered to a human having a low wake-up cortisol concentration. .
Note that the effects of the present technology are not limited to the effects described here, and may be any of the effects described in this specification.

It is a graph which shows the result of the lactoferrin administration to the human who has a high cortisol concentration at the time of getting up. It is a graph which shows the result of lactoferrin administration to the human who has a low cortisol concentration at the time of getting up.

  Hereinafter, preferred embodiments of the present technology will be described. However, the present technology is not limited to the following preferred embodiments, and can be freely modified within the scope of the present technology.

<Composition for adjusting the concentration of cortisol when awakened>
The compositions of the present technology are used to regulate cortisol levels at waking. The compositions of the present technology may be administered, for example, to a subject who is required to increase or decrease cortisol levels upon waking. This can contribute to improving the condition of the administration subject.
The active ingredient of the composition of the present technology is a milk-derived ingredient that has been used as a food for many years. This component is highly safe for living organisms. Therefore, the composition of the present technology can be safely administered to a subject to be administered, particularly a mammal, and more particularly a human.

  The composition of the present technology may be used to adjust the cortisol concentration at waking up of the administration subject according to the cortisol concentration of the administration subject. The compositions of the present technology are used, for example, to regulate cortisol levels in a subject who is required to increase or decrease cortisol levels.

In the present technology, “cortisol concentration at waking up” includes cortisol concentration before and after waking up. For example, the wake-up cortisol concentration may mean the cortisol concentration at any point during the period from 3 hours before wake-up to 3 hours after wake-up, and in particular, at any time during the period from wake-up to 3 hours after wake-up. The time point cortisol concentration may be referred to. The waking up cortisol concentration may be the highest cortisol concentration within 3 hours after waking up.
In the present technology, “cortisol concentration” means blood cortisol concentration or salivary cortisol concentration. It is known that there is a correlation between blood cortisol concentration and salivary cortisol concentration. The blood cortisol concentration means the concentration of cortisol in serum or plasma.

In accordance with one preferred embodiment of the present technology, the compositions of the present technology may be used to increase the concentration of subjects with low waking cortisol levels.
In the present technology, a subject having a low cortisol concentration at waking up means, for example, a subject having a blood cortisol concentration at waking up of 11.6 μg / dL or less, and in particular, 0.1 μg / dL to 11.6 μg / dl. , More particularly 1 g / dL to 11.6 g / dl. That is, the composition of the present technology may be used to increase the concentration of cortisol in subjects whose blood cortisol concentration at waking is 11.6 μg / dL or less. The compositions of the present technology can be administered, for example, in dosages and / or dosages described below, to increase the concentration of subjects with low wake-up cortisol levels or to increase cortisol production in subjects with low wake-up cortisol levels. Can be promoted. That is, the composition of the present technology may be used as a composition for increasing the concentration of cortisol at wake-up or a composition for promoting cortisol production at wake-up.
In the present technology, the blood cortisol concentration is measured by a CLIA method (chemiluminescence immunoassay).

In accordance with another preferred embodiment of the present technology, the compositions of the present technology may be used to lower the concentration of subjects with high waking cortisol levels.
In the present technology, a subject having a high cortisol concentration at waking up means, for example, a subject having a blood cortisol concentration at waking up of more than 11.6 μg / dL, particularly, more than 11.6 μg / dL to 50 μg / dl, More particularly, it refers to a subject that is more than 11.6 μg / dL to 30 μg / dl. That is, the compositions of the present technology may be used to reduce cortisol levels in subjects whose blood cortisol level at waking is greater than 11.6 μg / dL. By administering the compositions of the present technology, for example, the dosages and / or doses described below, the concentration can be reduced in subjects with high wake-up cortisol levels, or cortisol production is suppressed in subjects with high wake-up cortisol levels. can do. That is, the composition of the present technology may be used as a composition for lowering cortisol concentration at wake-up or a composition for suppressing cortisol production at wake-up.

  As described above, the relationship between cortisol concentration at waking and disease has been reported. As such, the compositions of the present technology may be used to prevent or alleviate diseases associated with waking up cortisol levels. For example, humans with burnout or Asperger's syndrome are known to have low cortisol levels at waking. Therefore, the composition of the present technology may be used for prevention or alleviation of burnout or Asperger's syndrome.

In the present technology, "prevention" is to prevent the onset of the disease, to reduce the risk of developing the disease, and to reduce the possibility of developing the disease, and to prevent at least one symptom of the disease from appearing Reducing the risk of developing at least one symptom of the disease, and reducing the likelihood of developing at least one symptom of the disease.
In the present technology, “alleviation” includes reducing the degree of a disease and reducing at least one symptom of the disease.

  Lactoferrin is an iron-binding glycoprotein present in body fluids such as milk, tears, saliva, and blood. Lactoferrin is contained in milk of mammals such as sheep, goats, pigs, mice, buffaloes, camels, yaks, horses, donkeys, llamas, cows or humans. That is, the lactoferrin used in the present technology may be derived from mammalian milk. From the viewpoints of content and availability, for example, those derived from bovine or human milk are preferred. The milk may be any of colostrum, transitional milk, normal milk, and terminal milk. In the present technology, commercially available lactoferrin may be used.

  Lactoferrin used in the present technology is not limited to those derived from mammalian milk. For example, lactoferrin separated from skim milk or whey obtained by treating the milk by a conventional method (eg, ion chromatography), recombinant lactoferrin produced from a microorganism, animal cell, or transgenic animal by genetic manipulation , Synthetic lactoferrin, or a mixture thereof. Lactoferrin may also be non-glycosylated or glycosylated.

The composition of the present technology has a daily lactoferrin intake of, for example, 10 mg or more, preferably 30 mg or more, preferably 100 mg or more, more preferably 200 mg or more, even more preferably 500 mg or more, particularly preferably 600 mg or more. It may be administered to a subject. Thereby, the effect of the present technology is more effectively achieved.
Further, the composition of the present technology may be administered to a subject such that the daily lactoferrin intake is, for example, 10,000 mg or less, preferably 2500 mg or less, more preferably 2000 mg or less. The upper limit of the lactoferrin intake may not be particularly set, but any of the above values may be set as the upper limit from the viewpoint of easy intake.
In the present technology, the lower limit and the upper limit of the numerical range of the daily intake of lactoferrin may be selected from the values listed above. For example, according to one embodiment of the present technology, a composition of the present technology may have a daily lactoferrin intake of, for example, 10 mg to 3000 mg, preferably 10 mg to 1000 mg, more preferably 100 mg to 1000 mg, more preferably 200 mg to 1000 mg, It may be administered to a subject more preferably from 500 mg to 1000 mg, even more preferably from 600 mg to 1000 mg. Alternatively, a composition of the present technology may be administered to a subject such that the daily lactoferrin intake is between 200 mg and 600 mg.

  The compositions of the present technology are preferably taken continuously. The compositions of the present technology may be administered continuously (e.g. daily, or e.g., for at least one week, preferably for at least two weeks, more preferably for at least three weeks, even more preferably for at least four weeks, particularly preferably for at least eight weeks). (At predetermined intervals, such as every other day or every other day). For example, the compositions of the present technology can be continuously (e.g., daily, or at predetermined intervals, e.g., every other day or every two days) for one month, two months, three months, or four months. T) may be taken. By such continuous ingestion, the effect of the present technology is more effectively achieved.

  The compositions of the present technology may be taken preferably before bedtime. For example, a composition of the present technology may be taken within 5 hours before bedtime, within 3 hours before bedtime, or within 1 hour before bedtime, or at any time after dinner and before bedtime. You may. By taking the composition of the present technology continuously before going to bed, the effects of the present technology can be more effectively achieved. Also, from the point of view of simplicity, the compositions of the present technology may preferably be taken orally.

  Although the content ratio of lactoferrin in the composition of the present technology may be appropriately set by those skilled in the art, for example, 0.01 to 99.9% by mass, preferably 0.5% to the total mass of the composition of the present technology. % By mass, more preferably 1% by mass to 50% by mass, even more preferably 5% by mass to 45% by mass.

The compositions of the present technology may be administered to subjects of all ages. The subject to which the composition of the present technology is administered is preferably a human. When the subject to which the composition of the present technology is administered is a human, the composition of the present technology can be used for a subject in infancy (for example, 0 to 5 years old), a subject in childhood (for example, 6 to 12 years old), an adolescent ( For example, it may be administered to a subject in the age of 13 to 17 years or a subject in adulthood (eg, 18 years or older).
The compositions of the present technology may be administered to non-human subjects. Subjects to which the composition of the present technology is administered include, for example, mammals other than humans. Non-human mammals include, for example, non-human primates, dogs, cats, cows, pigs, and horses.

  The composition of the present technology may be used, for example, as a medicine, food or drink, or feed. The composition of the present technology may appropriately include additional components included when used for these applications.

<Pharmaceutical composition>
The composition of the present technology can be used as a pharmaceutical composition. Pharmaceutical compositions of the present technology may be used to regulate cortisol levels upon waking.

  Since the active ingredient in the present technology is an ingredient derived from milk, which has been used as a food for many years, there is a high possibility that the active ingredient can be safely administered irrespective of the type of the patient's disease. Moreover, there is little need to worry about side effects even if the drug is administered continuously for a long period of time. Furthermore, safety is high even when used in combination with other drugs. For example, a pharmaceutical composition of the present technology may be administered to regulate wake-up cortisol concentration, along with a pharmaceutical composition for treating a disease associated with an abnormal rise in cortisol concentration.

  When the composition of the present technology is used as a pharmaceutical composition, the pharmaceutical composition may be administered orally or parenterally, and can be appropriately formulated into a desired dosage form depending on the administration method. For example, in the case of oral administration, it can be formulated into solid preparations such as powders, granules, tablets and capsules; liquid preparations such as solutions, syrups, suspensions and emulsions. In the case of parenteral administration, it can be administered, for example, via gastric fistula.

  In addition, at the time of formulation, the pharmaceutical composition of the present technology may include various components such as an excipient, a pH adjuster, a coloring agent, and a flavoring agent that are usually used for formulation. In addition, as long as the effects of the present technology are not impaired, the pharmaceutical composition of the present technology may include other known pharmaceutical ingredients. Formulation of the pharmaceutical composition of the present technology can be appropriately performed by a known method depending on the dosage form. At the time of formulation, a formulation carrier may be appropriately blended and formulated.

  In addition, the formulation can be appropriately carried out by a known method according to the dosage form. At the time of formulation, only the active ingredient lactoferrin may be formulated, or a formulation carrier may be appropriately compounded.

  When a pharmaceutical carrier is blended, the content of lactoferrin, which is an active ingredient of the present technology, may be appropriately selected according to the dosage form. The content ratio of lactoferrin as an active ingredient of the present technology is 0.01 to 60% by mass, preferably 0.5% to 55% by mass, more preferably 1% to 50% by mass based on the total mass of the pharmaceutical composition. It is even more preferred that the amount be from 5% by mass, more preferably from 5% by mass to 45% by mass.

The administration period of the pharmaceutical composition of the present technology may be appropriately determined according to the period during which the concentration of cortisol at the time of waking up needs to be adjusted. For example, a pharmaceutical composition of the present technology may be administered continuously (eg, daily, for example, for 1 week or more, preferably 2 weeks or more, more preferably 3 weeks or more, even more preferably 4 weeks or more, particularly preferably 8 weeks or more). Alternatively, it may be taken at predetermined intervals, such as every other day or every other day.
Pharmaceutical compositions of the present technology may be administered to subjects of all ages. That is, a composition of the present technology can be a subject in infancy (eg, 0-5 years), a subject in childhood (eg, 6-12 years), a subject in adolescence (eg, 13-17 years), or It may be administered to a subject in adulthood (eg, 18 years or older). Particularly preferably, the compositions of the present technology are administered to a subject in adulthood (eg, 18 years or older).
When the pharmaceutical composition of the present technology is ingested, the present technology is designed such that the daily intake of lactoferrin is, for example, 10 mg to 10000 mg, preferably 10 mg to 1000 mg, more preferably 100 mg to 1000 mg, and still more preferably 200 mg to 600 mg. May be ingested.

  Further, as the pharmaceutical carrier, various organic or inorganic carriers and bases can be used according to the dosage form. Ingredients used for formulation of the compositions of the present technology include, for example, excipients, binders, disintegrants, lubricants, stabilizers, and flavoring agents.

  As the excipient, for example, sugar derivatives such as reduced maltose, lactose, sucrose, glucose, mannitol, and sorbitol; starch derivatives such as corn starch, potato starch, α-starch, dextrin, carboxymethyl starch; crystalline cellulose, hydroxy cellulose Cellulose derivatives such as propylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, and carboxymethylcellulose calcium; gum arabic; dietary fiber; dextrin; dextran; pullulan; Phosphate derivatives such as calcium carbonate; sulfate derivatives such as calcium sulfate; and the like.

  Examples of the binder include, in addition to the above-mentioned excipients, gelatin; polyvinylpyrrolidone; macrogol and the like.

  Examples of the disintegrant include, in addition to the above-mentioned excipients, chemically modified starch or cellulose derivatives such as croscarmellose sodium, sodium carboxymethyl starch, and crosslinked polyvinylpyrrolidone.

  Examples of the lubricant include talc; stearic acid; metal stearate such as calcium stearate and magnesium stearate; colloidal silica; waxes such as pea gum and gay wax; boric acid; glycol; carboxylic acids such as fumaric acid and adipic acid; Sodium salts such as sodium benzoate; sulfates such as sodium sulfate; leucine; lauryl sulfates such as sodium lauryl sulfate and magnesium lauryl sulfate; silicic acids such as silicic anhydride and silicic acid hydrate; starch derivatives and the like; And hardened oils such as rapeseed hardened oil.

  Examples of the stabilizer include paraoxybenzoic acid esters such as methylparaben and propylparaben; alcohols such as chlorobutanol, benzyl alcohol and phenylethyl alcohol; benzalkonium chloride; acetic anhydride; and sorbic acid.

  Examples of the flavoring agent include sweeteners, sour agents, flavors and the like.

<Food and drink>
The composition of the present technology may be a food or beverage composition. The food and drink composition of the present technology may be used to adjust the concentration of cortisol at waking up.

Examples of the food and drink composition of the present technology include, for example, beverages such as soft drinks or dairy beverages or concentrated stock solutions of the beverages and powders used for preparing the beverages; dairy products such as processed milk and fermented milk; Milk powder; enteral nutrition diet; and functional food.
Examples of the food and drink composition of the present technology include, for example, beverages such as carbonated beverages, nutritional beverages, and fruit beverages or concentrated stock solutions of the beverages and powders used for preparing the beverages; for example, ice creams and ice sorbets And noodles such as buckwheat, udon, harusame, gyoza skin, sweet potato skin, Chinese noodles and instant noodles; candy, gum, chocolate, tablet confectionery, snacks, biscuits, jelly, jam, Confectionery such as cream and baked goods; processed marine or livestock products such as kamaboko, ham, and sausage; processed fats and oils and fats such as salad oil, tempura oil, margarine, mayonnaise, shortening, whipped cream, and dressing; Seasonings such as sauces and sauces; Flop, mention may be made of stew, salad, prepared foods, pickles, and the cooked food, such as bread. The food and drink composition of the present technology may be, for example, a liquid or tablet supplement.

  These foods and drinks may be produced by methods known to those skilled in the art. In these methods for producing foods and drinks, the time and method of adding lactoferrin may be appropriately selected by those skilled in the art.

In addition, the food and drink composition of the present technology can be provided or sold as a food or drink in which a health use for increasing or decreasing the cortisol concentration at wake-up or a health use for cortisol concentration at wake-up is indicated.
The "display" act includes all acts for notifying the user of the use, and if the expression is such that the use can be recalled or analogized, the purpose of the display, the content of the display, and Regardless of the object or medium to be displayed, all of them fall under the “display” act of the present technology.
The food and drink composition of the present technology may be labeled with, for example, "to increase the cortisol concentration at waking up" or "to decrease the cortisol concentration at waking up".

  “Display” is preferably performed in an expression that allows the consumer to directly recognize the use. To be specific, transfer, transfer, display or display the product for food and drink or the product packaging for which the above-mentioned use is described for the purpose of transfer or delivery, and import the product, advertisement for the product, price list or transaction documents. The above-mentioned use may be described and displayed or distributed, or an act of describing the above-described use in information containing the contents and providing the information by an electromagnetic (such as the Internet) method may be mentioned.

  The display content is preferably a display approved by the government or the like (for example, a display that is approved based on various systems determined by the government and is performed in a form based on such approval). In addition, it is preferable to attach such display contents to advertising materials at a sales site such as packaging, containers, catalogs, pamphlets, POP (Point of purchase advertising), and other documents.

  In addition, "label" means that the product is, for example, a health food, a functional food, an enteral nutrition food, a special use food, a health food, a specified health food, a nutrition food, or a quasi-drug Is displayed. As a more specific example of a label, a label preferably approved by the Consumer Affairs Agency, for example, a label approved in a food for specified health use system or a similar system is exemplified. Examples of labeling approved by the Consumer Affairs Agency include, for example, labeling as food for specified health use, labeling as food for specified health condition, labeling that affects the structure and function of the body, and labeling for reducing disease risk. Can be mentioned. More specifically, labeling as food for specified health use (especially labeling of health use) specified in the Health Promotion Law Enforcement Regulations (Ordinance No. 86 of the Ministry of Health, Labor and Welfare on April 30, 2003) and A similar display is a typical example.

  The content of lactoferrin contained in the food or drink of the present technology may be appropriately selected by those skilled in the art. The content ratio of lactoferrin which is an active ingredient of the present technology is 0.01 to 60% by mass, preferably 0.5% to 55% by mass, more preferably 1% by mass to the total mass of the food and drink composition. It is even more preferred that it is 50% by mass, even more preferably 5% by mass to 45% by mass.

The intake period of the food or drink of the present technology may be appropriately determined depending on the period during which the concentration of cortisol at the time of rising needs to be adjusted. For example, the food or drink of the present technology is continuously (eg, daily, or daily) for, for example, 1 week or more, preferably 2 weeks or more, more preferably 3 weeks or more, still more preferably 4 weeks or more, and particularly preferably 8 weeks or more. (E.g., at predetermined intervals, such as every other day or every other day).
When ingesting the food or drink composition of the present technology, the amount of lactoferrin may be 10 mg to 10000 mg, preferably 10 mg to 1000 mg, more preferably 100 mg to 1000 mg, even more preferably 200 mg to 600 mg per day. Technical food and beverage compositions may be ingested.

The present technology also provides the following methods and articles.
[1] A method of using lactoferrin for producing a composition for adjusting the concentration of cortisol at waking up.
[2] Lactoferrin for controlling cortisol concentration at waking up.
[3] A method of adjusting cortisol concentration at waking up by administering lactoferrin.

  Hereinafter, the present technology will be described in more detail using examples, but the present technology is not limited to these examples.

[Test Example 1]
(1) Preparation of Sample The following ingredients were mixed at the mixing ratios shown in Table 1 below and tableted according to a conventional method to produce three types of tablets each weighing 250 mg. That is, a control sample containing no lactoferrin, a test sample A containing 33.3 mg of lactoferrin per tablet, and a test sample B containing 100 mg of lactoferrin per tablet were obtained.

(2) Test method A randomized, double-blind, placebo-controlled, parallel-group comparative study was performed using the above samples to examine the effect of lactoferrin intake on cortisol concentration at waking. The test was performed as follows.
That is, a group of 120 healthy adults who agreed to participate in this test were to take a control sample after a 4-week pre-observation period (hereinafter, may be referred to as a “control group”) and a test sample A. They were randomly assigned to a group to be ingested (hereinafter sometimes referred to as “test group A”) and a group to ingest test sample B (hereinafter sometimes referred to as “test group B”).
Subjects in each group took 6 tablets of one of the control sample, test sample A or test sample B once a day for 12 weeks before going to bed. That is, the test group A subjects took 200 mg of lactoferrin per day, and the test group B subjects took 600 mg of lactoferrin per day. Before the start of ingestion and 12 weeks after the start of ingestion, the blood cortisol concentration of each subject at waking was measured. Blood was collected from each subject at one hour after waking up. The blood cortisol concentration was measured by the CLIA method (chemiluminescence immunoassay).

(3) Statistical analysis Blind results were reviewed before key opening. The analysis was performed excluding those who did not meet the predefined criteria for analysis (ie, those who received contraindicated treatment, those who took prohibited drugs or foods), and those who had no data after randomization. The number of subjects to be analyzed was n = 38 for the control group, n = 35 for test group A, and n = 37 for test group B.
The blood cortisol concentration of 38 subjects in the control group before the start of ingestion of the control sample was 11.6 μg, which is the median of 3.7 to 19.4 μg / dL, which is the reference value of the cortisol measurement concentration of LSI Medience Corporation. Subjects with a value of / dL or less were set as a low value group, and subjects with a value of more than 11.6 μg / dL were set as a high value group. The number of subjects in the high-value group was 19, and the number of subjects in the low-value group was 19. The difference between the cortisol concentration at waking before the control sample ingestion of the subjects in the high value group and the cortisol concentration at waking at 12 weeks after the start of ingestion was calculated, and the average value was calculated. The difference was calculated by the same calculation method also for the subjects in the low value group.
Regarding test group A, the blood cortisol concentration before the start of ingestion of test sample A was divided into a high value group and a low value group by the same method. The number of subjects in the high value group was 20, and the number of subjects in the low value group was 15. Then, for each of the high value group and the low value group, the difference between the wake-up cortisol concentration before the start of the test sample A intake and the wake-up cortisol concentration at the 12th week after the start of the intake was calculated, and the average value was calculated. .
In the test group B, the blood cortisol concentration before the start of the test sample B ingestion was divided into a high value group and a low value group by the same method. The number of subjects in the high value group was 16 and the number of subjects in the low value group was 21. Then, for each of the high value group and the low value group, the difference between the wake-up cortisol concentration before the start of the test sample B intake and the wake-up cortisol concentration at the 12th week after the start of the intake was calculated, and the average value was calculated. .

(4) Results The results of the above statistical analysis are shown in Tables 2 and 3 below and FIGS.
Table 2 and FIG. 1 show the control group, the test group A, and the average value of the cortisol concentration at wake-up before the ingestion of the high value group of each test group B, the average value of the cortisol concentration at wake-up at 12 weeks after the start of the ingestion, In addition, the average value of the difference between the cortisol concentration at the time of waking up before the start of ingestion and 12 weeks after ingestion is shown.
Table 3 and FIG. 2 show the average value of the cortisol concentration at wake-up before the ingestion of the control group, the test group A, and the low-value group of the test group B, and the average value of the cortisol concentration at the wake of 12 weeks after the start of the ingestion, In addition, the average value of the difference between the cortisol concentration at the time of waking up before the start of ingestion and 12 weeks after ingestion is shown.

As shown in Table 2 and FIG. 1, in the high-value group of the control group, the average value of the difference between the cortisol concentration at wake-up before ingestion and the cortisol concentration at wake-up at 12 weeks was 0.1. . On the other hand, in test group A, the difference was -1.1, and in test group B, the difference was -2.5.
As described above, in the high-value group of the control group not taking lactoferrin, there was almost no change in the cortisol concentration, but in the high-value groups of test groups A and B that took lactoferrin, the cortisol concentration decreased at 12 weeks after the start of ingestion. did.
Moreover, in the high value group of the test group B in which the lactoferrin intake was higher, the cortisol concentration was much lower. Therefore, it can be seen that the higher the intake, the more the cortisol concentration falls. The P value between the high value group of the test group B and the high value group of the control group was less than 0.1.

As shown in Table 3 and FIG. 2, in the low-value group of the control group, the average value of the difference between the cortisol concentration at wake-up before starting the intake and the cortisol concentration at wake-up at 12 weeks was 0.3. Was. On the other hand, in test group A, the difference was 1.9, and in test group B, the difference was 2.6.
As described above, there was almost no change in cortisol concentration in the low-value group of the control group not taking lactoferrin, but in the low-value group of test groups A and B that took lactoferrin, the cortisol concentration was 12 weeks after the start of ingestion. Rose.
Further, in the low value group of the test group B in which the lactoferrin intake was higher, the cortisol concentration increased more significantly. Therefore, it can be seen that the higher the intake, the higher the cortisol concentration. The P value between the high value group of the test group B and the high value group of the control group was less than 0.05, and the P value for the tendency according to the intake was also less than 0.05.

From the above results, it can be seen that the cortisol concentration at wake-up can be adjusted by lactoferrin ingestion. In particular, it can be seen that lactoferrin intake can lower the wake-up cortisol concentration in subjects with high wake-up cortisol concentrations, and that lactoferrin intake can increase the wake-up cortisol concentration in subjects with low wake-up cortisol concentrations. .
Furthermore, it is also found that the effect of lactoferrin ingestion increases according to the amount of lactoferrin intake. When the lactoferrin intake is 600 mg per day, the effect of lowering or increasing the cortisol concentration at waking up is more strongly exerted than when the lactoferrin intake is 200 mg per day.

Claims (6)

  A composition for adjusting the concentration of cortisol at waking up, which comprises lactoferrin as an active ingredient.   The composition according to claim 1, wherein the composition is for adjusting a blood or salivary cortisol concentration.   The composition according to claim 1, wherein the subject to which the composition is administered is a human.   The composition according to any one of claims 1 to 3, wherein the composition is administered such that a lactoferrin intake is 10 mg or more per day.   The composition according to any one of claims 1 to 4, wherein the composition is a food or drink composition. The composition according to any one of claims 1 to 4, wherein the composition is a pharmaceutical composition.