WO2012112116A1

WO2012112116A1 - Foodstuff comprising an extract mixture

Info

Publication number: WO2012112116A1
Application number: PCT/SE2012/050171
Authority: WO
Inventors: Per BELFRAGE; Pirjo WIENA
Original assignee: WELLBEMED SWEDEN AB
Current assignee: WELLBEMED SWEDEN AB
Priority date: 2011-02-16
Filing date: 2012-02-16
Publication date: 2012-08-23
Anticipated expiration: 2013-08-16
Also published as: EP2675297A1; EP2675297A4

Abstract

The present invention discloses a foodstuff comprising an extract mixture comprising a hops (Humulus lupulus) extract in a content of 250 - 2500 mg, calculated on dry hops raw material, and a lemon balm (Melissa officinalis) extract in a content of 500 - 7000 mg, calculated on dry balm raw material. The total content of hops extract and lemon balm extract together is in the range 1500 - 9500 mg. Said foodstuff, which preferably is essentially free from valerian or other sopoforic components, is suitable for providing help for persons having trouble falling asleep.

Description

FOODSTUFF COMPRISING AN EXTRACT MIXTURE

Field of the invention

The present invention refers to a foodstuff facilitating falling asleep at night.

Technical background

Pharmaceuticals and nature-cure medicine intended to counteract sleep problems exist on the market today. Some of these are based on natural products, such as herbs and plants.

However, there exists a need for functional foodstuffs which are both easy and pleasant to consume, but which are also effective with reference to intended effect. The present invention aims at providing such an effective foodstuff for providing possible help for persons having problems falling asleep, which foodstuff is based on natural raw materials, has enhanced and optimized effect with reference to providing help according to above, but which also has other favorable properties, such as user friendliness, good taste, etc.

Summary of the invention

The purpose above is obtained by a foodstuff comprising an extract mixture, said extract mixture comprising a hops extract in a content of 250 - 2 500 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 500 - 7 000 mg, calculated on dry lemon balm raw material, wherein the total content of hops extract and lemon balm extract together is in the range of 1 500 - 9 500 mg calculated on dry raw material and per portion of foodstuff. According to one specific embodiment of the present invention, said extract mixture comprises a hops extract in a content of 250 - 2 000 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 500 - 5 750 mg, calculated on dry lemon balm raw material, wherein the total content of hops extract and lemon balm extract together is in the range of 1 500 - 6 000 mg calculated on dry raw material and per portion of foodstuff. Moreover, it should be noted that a combination of for instance a hops extract in a content of 250 - 2 500 mg and a lemon balm extract in a content of 500 - 5 750 mg giving a possible total range of from 1 500 - 8 250 mg, and also a combination a hops extract in a content of 250 - 2 000 mg and a lemon balm extract in a content of 500 - 7 000 mg giving a possible total range of from 1 500 - 9 000 mg, both calculated as according to above, are also fully possible according to the present invention.

A foodstuff according to the invention has an advantageous combined extract content of hop strobile (Humulus lupulus) and lemon balm (Melissa officinalis) to be able to obtain a suitable and optimal soporific profile for the intended use, and where the effect has been obtained by the delivery of completely natural raw materials to a foodstuff.

By "foodstuff is herein not meant raw materials but industrially refined foodstuffs. Examples of such foodstuffs are juice, milk, yoghurt, snacks, etc.

The expression "per portion of foodstuff" should be interpreted as an intended portion for a person to consume. This measure depends on certain factors, such as type of foodstuff and the body weight of the consumer, etc., and this is further discussed below.

Detailed description of the invention

The components hops and lemon balm are known since before, and they are used in foodstuffs today, such as e.g. together in some beer types. Furthermore, it is known that they each have a sedative effect. See for example the Russian patent publication RU2136181 C1 in which it is described a sedative elixir intended as a non-alcoholic beverage and which comprise lemon balm. Furthermore, in the Russian patent publication RU2215536C2 there is also disclosed what is said to be a biological active supplement which has sedative effect and which comprise lemon balm and hops. Hops is often used in combination with other sedative medical plants, for instance valerian and lemon balm. The hops is considered to improve the sleep at even very low doses. In nature-cure medicine, the two components hops and lemon balm are used in certain tablets. The additive according to RU2215536C2 comprises many different components, such as, besides lemon balm and hops, components like valerian, lavender, etc. Valerian is in itself a strong natural sedative component.

According to the present invention, the extract mixture used is preferably completely free from valerian, or at least shall the amount be so low so that valerian cannot be considered as an active component in the extract mixture. Therefore, according to one embodiment of the present invention, the foodstuff is free from or substantially free from valerian.

According to the present invention, preferably only hops and lemon balm are the two active components in the extract mixture. Therefore, according to one embodiment of the present invention, the foodstuff is, besides of hops and lemon balm, free from other soporific components in any influencing amounts. Such components are e.g. valerian of course, but other examples said to at least promoting a calming or pleasuring effect are camomile, St. John's wort, and lavender, but also for instance heather may be such a component.

The expressions "substantially free from" and "free from other soporific components in any influencing amounts" should be understood as implying not containing any such components as intended for achieving any soporific effect. The components may in some case be contained in really small amounts, e.g. in trace amounts.

Moreover, the expression "active" should in this sense be linked to the intended use, i.e. for promoting soporific effect. The contents of hops and lemon balm in the extract mixture according to the present invention are such that valerian or other possible active components should not be admixed in any influencing amounts. When reviewing RU2215536C2, no actual content levels of hops and lemon balm seem to be disclosed, however, they are not provided in a mixture as the sole active components. An extract mixture where only these two components are the active components, as they have proven to give an optimal soporific profile, is, however, the core of the present invention. Also other documents disclose the use of valerian together with lemon balm and hops. Examples are W00051586A2, DE20201001 1306U1 , US6391346B1 and W02007095716A1 . None of these documents show content levels as according to the present invention, and do not relate to the benefits of only having lemon balm and hops as active components present.

In relation to the above discussed matter, there also exist other known herb mixtures where both hops and lemon balm are used, and where valerian is not present. For instance in EP1623716A1 there is disclosed pharmaceuticals and food additives containing both lemon balm and hops. In one of the examples there is shown a tea composition comprising 75% lemon balm and 12.5% hops. If the amount of lemon balm and hops where to be recalculated to dry raw material, such as according to the present invention, the content of lemon balm extract would be about or somewhat over 50 mg and the content of hops extract would be somewhat below 10 mg. This is not anyway within the specification according to the present invention, and the benefits of only having lemon balm and hops as active components present are not hinted in EP1623716A1 . Once again, the content of lemon balm and hops extracts is a core feature according to the present invention. It is these content levels that are linked to the intended effect.

The present invention is directed to a novel product concept for a foodstuff where the content of hops in relation to the content of lemon balm has been optimized with reference to several important parameters, such as to give an optimal soporific effect to achieve an effective but careful aid for people having difficulties falling asleep, to allow for high user friendliness with respect to taste and at the same time to provide certain feeling of satisfaction to the user which favors the intended use.

It should be noted that different types of extract raw materials may be used for the present invention. The extracts may be concentrated in various much with basis from the raw materials hops and lemon balm. As noted from above, the given ranges are thus based on dry raw materials. The expression "raw material" implies the starting raw material, i.e. leaves, stem, or the like, where concentrated extracts have not yet been extracted. According to the present invention it should be noted that it is primarily the active parts of lemon balm and hops that are intended according to the present invention, and as such contained in the extracts used. In case of lemon balm it is the leaves that constitute this active part, and for hops it is the so called cones. It should, however, be noted that also other parts of these plants may take part of the extracts as this is dependent on the harvesting.

Moreover, the expression "calculated on dry raw material" should be interpreted as it is defined according to WC500059285 and WC500059221 , respectively, issued by the European Medicines Agency, Evaluation of Medicines for Human Use, COMMITTEE ON HERBAL MEDICINAL

PRODUCTS (HMPC), in which it is clearly shown that "herbal substance, cut and dried" are used as definitions.

Furthermore, the extracts according to the present invention may be present in both dried forms, such as a powder, or in liquid form. Moreover, and also notable from WC500059285 and WC500059221 , different types of extraction agents are possible to use to yield the lemon balm- and hops extract raw materials according to the present invention. Examples are ethanol and water.

Moreover, typical concentration levels in yielded extracts are e.g.

concentrated 10 times (10: 1 ) in relation to the raw material, but also extracts in concentrations of e.g. 6: 1 and 4: 1 exist. All variants are possible according to the present invention, but it should in such case be noted that given content ranges should be recalculated. For example, if the hops extract and the lemon balm extract are concentrated 10 times in relation to the raw materials, then the possible ranges according to the present invention should be read as 25 - 250 mg for the hops extract and 50 - 700 mg for the lemon balm extract and where the total content for both extracts may be in the range of 150 - 900 mg. As an example, if the hops extract and the lemon balm extract are concentrated 10 times in relation to the raw materials, according to one embodiment of the present invention the ranges may e.g. be set as 25 - 250 mg for the hops extract and 50 - 575 mg for the lemon balm extract and where the total content for both extracts e.g. may be in the range of 150 - 600 mg. On the other hand, if the extracts are concentrated 5 times in relation to the dry raw materials, then the ranges according to that same embodiment of the present invention are 50 - 500 mg for the hops extract and 100 - 1 150 mg for lemon balm extract and where the total content of both extracts e.g. is in the range of 300 - 1 200 mg instead.

The present invention solves several issues. First of all, the content of the two active components each are optimized with respect to desired effect. The content of each of these components may vary within the given ranges per portion of foodstuff. According to one specific embodiment, the extract mixture comprises a hops extract in a content of 250 - 500 mg, calculated on dry hops raw material and per portion of foodstuff. As is discussed more below, hops has a very acrid or bitter taste, which makes it important to suppress the taste intensity from this component if it is contained in the foodstuff in a higher content. On the account of the above mentioned taste influence, it may according to the present invention also be favorable to have a considerably higher content of lemon balm than hops in the foodstuff, such as about 90% lemon balm extract and about 10% hops extract. Therefore, according to one specific embodiment, the extract mixture comprises a hops extract in a content of 250 - 500 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 3 500 - 5 750 mg, calculated on dry hops raw material, calculated per portion of foodstuff. Different variants within these ranges are totally possible per portion of the foodstuff.

The amount for a portion of foodstuff may vary depending on the actual foodstuff. Generally speaking, a portion of foodstuff may be seen as comprising 20 - 200 g according to the present invention. If for example the foodstuff is a bar according to the present invention this may weigh e.g. 25 g (e.g. 20 - 50 g) and constitute a portion of foodstuff. Such a cookie or bar may for instance contain oat and chocolate, and optionally nuts. In another case a glass of milk of e.g. 1 - 2 dl (about 100 - 200 g) is intended as a portion of foodstuff according to the present invention. Also e.g. a drinkable shot, e.g. based on milk but perhaps also containing chocolate would portion wise may constitute about 80 - 120 ml, i.e. about 80 - 120 g of foodstuff.

It should be noted that a portion of foodstuff may also be linked to body weight for the person who is about to consume a foodstuff according to the present invention. The given amounts are stated for a user weighing about 75 kg and it should be understood that the ranges for suitable portion of foodstuff may be changed for someone weighing considerably less or more

proportionally based on the specific body weight. It should be noted that the higher part of the given ranges, such as e.g. a hops extract in a content of almost 2 500 mg, calculated on dry hops raw material, and a lemon balm extract in a content of almost 7 000 mg, calculated on dry lemon balm raw material, i.e. implying a total of almost 9 500 mg calculated on dry raw material and per portion of foodstuff, is a really high level and is in most cases more suitable for a person weighing above 75 kg, such as for instance 100 kg. For a normal average weight of 60-80 kg, the level implying an extract mixture comprising a hops extract in a content of 250 - 2 000 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 500 - 5 750 mg, calculated on dry lemon balm raw material, and a total content of hops extract and lemon balm extract together in the range of 1 500 - 6 000 mg calculated on dry raw material and per portion of foodstuff, is preferable.

The foodstuff according to the present invention has soporific effect and is intended to be consumed by a user having temporary difficulties falling asleep. This effect of the foodstuff according to the present invention is exhibited by the experiments reported for below, where the influence on the reaction time is shown. According to one specific embodiment of the present invention, the foodstuff increases the reaction time with at least 5% within a time period of from 20 min to 60 min after consumption of the foodstuff. With respect to this a number of different favorable effects of the foodstuff according to the present invention should be mentioned. The first thing is the effect per se. It is important that the obtained effect is neither too little nor too powerful, but that an optimal soporific profile may be obtained. Another positive effect with the foodstuff according to the present invention is the effect profile. It is of interest to obtain a profile with is linked with the sleeping profile so that an effect peek is obtained during the stage of falling asleep which then is decreased when the user is sleeping heavier. It is this soporific profile that a foodstuff according to the present invention obtains, which is discussed in more detail below in relation to performed experiments.

As mentioned above, hops has a bitter taste. This brings about that it in some cases would be beneficial to counteract this taste intensity, such as when the content of hops is proportionately high in the foodstuff. Thus, according to one specific embodiment of the present invention, at least the hops extract is added to the foodstuff in an encapsulated form. This may for instance be accomplished by the hops extract from the beginning produced in a granular form which additionally has been coated. Such a coating should of course be a foodstuff accepted additive. When hops is added in an

encapsulated form, it is according to the present invention possible to be positioned in the higher part of the content range of hops, such as e.g.

between 1 000 and 2 000 mg, calculated on dried hops raw material.

The encapsulation of the extract particles or granules, especially in relation to the hops extract, may be accomplished by different means.

According to one specific embodiment this is accomplished by means of microencapsulation, nanoencapsulation or by the creation of an emulsion.

As is revealed above, it is not only the hops extract that may be encapsulated according to the present invention. Fact is that this may also be true for the lemon balm extract. Moreover, both extracts may be produced together in some particle form (e.g. granules) which subsequently is surface coated or encapsulated with technologies according to above. This is due to the fact that it is not only the hops taste that may be counteracted by encapsulation, but this action may further cause a slow (delayed) release of the extract mixture and its effect during consumption of a foodstuff. This may for instance be of interest to influence the level of dosage of hops and lemon balm added and how these then are released in the body and thus also how and when the effect starts, is maximized and is decayed. This for instance to accomplish a matching (linkage) to the energy content in the foodstuff so that a bracing effect from the energy content and a soporific effect from hops and lemon balm does not occur simultaneously and thus counteract each other. This effect profile is thus possible to control according to the present invention by affecting dosage/amount of active substances (hops and lemon balm), by affecting other ingredients, thereby affecting the release of the active substances in the body after consumption of the foodstuff. The foodstuff according to the present invention shall provide some satisfaction feeling, which is good as the foodstuff is intended as an aid for falling asleep, and it shall thus not be energy stimulating which could give a counteracting effect.

The foodstuff according to the present invention may be of different type. According to one specific embodiment, the foodstuff is a beverage, such as e.g. milk, juice ("shot") or a chocolate beverage. According to another specific embodiment, the foodstuff is milk. With respect to this case, a portion of foodstuff is e.g. about 1 - 2 dl, such as between 100 and 200 g, e.g. about 150 g.

According to another specific embodiment of the present invention, the foodstuff is a solid food. It may for instance be mentioned that a portion of solid foodstuff often has a lower weight than a portion of a beverage foodstuff. As an example, a bar having a weight of between about 20 and 100 g may be mentioned as such an intended portion being suitable to consume before the user is about to go to sleep. Moreover, it is common that a solid foodstuff, such as a cookie, bar, cracker, (chocolate) biscuit, or the like, contains relatively energy rich ingredients, such as oat, honey, chocolate, etc, which renders some satisfaction to the user. This implies that less weight of such a solid foodstuff often contains about the same energy content as a higher weight of a beverage which in itself contains a lot of water. As it according to the present invention is of interest to make sure that the portion gives a minor feeling of satisfaction, however not being energy stimulating, a portion of a solid foodstuff is often less than for a beverage. A suitable range for a solid foodstuff is e.g. from 20 to 150 g, and for e.g. a relatively energy rich bar or the like, the suitable portion weight is in the range of 20 - 50 g, e.g. 20 - 35 g, such as 25 g. Once again, it is of course entirely dependent on the satisfac- tion level obtained by a certain foodstuff. It should be understood that a portion of foodstuff not necessarily must imply an entire one piece of foodstuff, but may instead constitute a part of a foodstuff. If the foodstuff is in the form of a bar it is naturally more suitable that the foodstuff constitutes one single portion and as such is consumed completely each time.

Foodstuffs possible to be regarded as something in between solid and liquid, such as yoghurt or the like, may also be a foodstuff according to the present invention.

Performed experiments

Experiments have been performed in order to evaluate the effect of a foodstuff according to the present invention. These trials have been based on the measuring of the reaction time at different time points after the intake of foodstuffs comprising the extract mixture according to the present invention compared to the reaction time before such an intake (control). The reaction time constitutes the time from the time when a dator signal is perceived by a subject's ear to the time when this subject has shut off the signal by pushing a button, normally within the range of 130 - 180 milliseconds (ms). This type of measuring is well-known, even if not very technically advanced in comparison to the one used in the actual measuring method, for instance in "A Literature Review on Reaction Time" by Robert J. Kosinski, Clemson University, latest edition in the year of 2010.

In table 1 below a performed experiment series where the intake constituting 1 dl milk (1 .5% fat content) comprising the extract mixture according to the present invention has been taken by a subject weighing about 60 kg. The foodstuff contained totally 500 mg of the extract mixture, with 450 mg lemon balm extract and 50 mg hops extract, where the extracts were concentrated 10 times in relation to raw material, i.e. 10:1 . This implies that the foodstuff contained 5 000 mg of the extract mixture calculated on dry raw material.

The observation at 0 minutes constitutes the control. This has been registered at 4 minutes before the intake of the milk. The level for the control has of course been established by several trials, and the level is statistically assured. In other words, all of the control tests have been performed without the intake of any extract mixture, i.e. by consuming milk not containing any of the extract mixture according to the present invention.

In this case, the control was set to 131 ms. The trials were performed at two different occasions. The reaction time, given in milliseconds (ms), was measured at 20, 40 and 60 minutes after intake, at which time points the sound influence is performed at 88 randomized (2 - 4 s) occasions during 4 minutes of observation. The given values for the reaction time in table 1 below are based on medians of the registered values. In table 1 , the reaction time difference in relation to the control and the statistical significance (based on Wilcoxon analysis) are shown. Table 1 (NA = Non-applicable)

From table 1 it may be seen that the reaction time increased after the intake (consumption) of the milk according to the present invention. As may be seen, the increase of the reaction time was larger after 60 min than after 20 and 40 min. It may be noted that several performed experiments show that this effect decays after about 80 min so that the reaction time difference in relation to the control is thereafter decreased until it returns to the measured value for the control (see table 2 and table 3). It is this effect curve with a peak somewhere between 20 and 60 min and where the effect thereafter stops that is of large interest to obtain an optimized soporific profile.

In table 2 below another experiment series is shown, performed the same way as according to above and with the same foodstuff according to above, i.e. 1 dl milk comprising totally 500 mg of extract mixture, with 450 mg lemon balm extract and 50 mg hops extract, where the extracts were concentrated 10 times in relation to raw material. Also in this case, the subject weighed about 60 kg and the assured control was 134 ms in this case.

Table 2 (NA = Non-applicable)

at 80 min. It should be noted that the control time may vary from person to person. The absolute values for the control and thus also after the measuring at 20, 40, 60 or 80 min according to above is not the key matter in this case. The increase of the reaction time is the key matter to evaluate. This difference may e.g. be seen when comparing table 2 and 3.

In table 3 below yet another experiment series is shown, performed the same way as according to above. In this case the foodstuff was also 1 dl milk (1 .5% fat content), but where the milk contained 400 mg of the extract mixture (360 mg lemon balm extract and 40 mg hops extract, where the extracts were concentrated 10 times in relation to raw material). In this case, the subject weighed about 90 kg. The assured control was 144 ms in this case.

Table 3 (NA = Non-applicable)

In this case the results show that the effect has decayed completely after 100 min.

The showed increase in reaction time according to above may be linked to the fact that the subjects have become less alert after the intake of a foodstuff according to the present invention and that the foodstuff as such function as an aid for people having difficulties falling asleep.

Claims

1 . Foodstuff comprising an extract mixture, said extract mixture comprising a hops extract in a content of 250 - 2 500 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 500 - 7 000 mg, calculated on dry lemon balm raw material, wherein the total content of hops extract and lemon balm extract together is in the range of 1 500 - 9 500 mg calculated on dry raw material and per portion of foodstuff.

2. Foodstuff according to claim 1 , wherein the extract mixture comprises a hops extract in a content of 250 - 2 000 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 500 - 5 750 mg, calculated on dry lemon balm raw material, wherein the total content of hops extract and lemon balm extract together is in the range of 1 500 - 6 000 mg calculated on dry raw material and per portion of foodstuff.

3. Foodstuff according to claim 1 or 2, wherein the foodstuff is free from or substantially free from valerian.

4. Foodstuff according to any of claims 1 -3, wherein the foodstuff, besides hops and lemon balm, is free from other soporific components in any influencing amounts.

5. Foodstuff according to any of claims 1 -4, wherein the extract mixture comprises a hops extract in a content of 250 - 500 mg, calculated on dry hops raw material and per portion of foodstuff.

6. Foodstuff according to any of claims 1 -5, wherein the extract mixture comprises a hops extract in a content of 250 - 500 mg, calculated on dry hops raw material, and a lemon balm extract in a content of 3 500 - 5 750 mg, calculated on dry hops raw material, calculated per portion of foodstuff.

7. Foodstuff according to any of claims 1 -6, wherein a portion of foodstuff weighs 20 - 200 g.

8. Foodstuff according to any of claims 1 -7, wherein the foodstuff increases the reaction time with at least 5% within a time period of from 20 min to 60 min after consumption of the foodstuff.

9. Foodstuff according to any of claims 1 -8, wherein at least the hops extract is added to the foodstuff in an encapsulated form.

10. Foodstuff according to claims 9, wherein the encapsulated form is provided by microencapsulation, nanoencapsulation or by the creation of an emulsion.

1 1 . Foodstuff according to any of claims 1 -10, wherein the foodstuff is a beverage.

12. Foodstuff according to claim 1 1 , wherein the foodstuff is milk.

13. Foodstuff according to any of claims 1 -10, wherein the foodstuff is a solid food.

14. Foodstuff according to claim 13, wherein the foodstuff is a cookie or a bar.