COMPOSITION USED AS A MOOD-REGULATING STIMULANT

Abstract

Disclosed is a composition used as a mood-regulating stimulant comprising a gum base which contains 0.1 to 1 wt % of lavender oil.

Claims

1. A composition comprising lavender oil as an active ingredient for medicinal use in a treatment of a concentration disorder, and a gum base, wherein the composition comprises the gum base, and lavender oil as an active ingredient is in a concentration of 0.1 to 1 wt %, preferably 0.2 to 0.4 wt %, more preferably 0.3 wt %.

2. The composition according to claim 1, wherein the lavender oil is the sole active ingredient.

3. The composition according to claim 1, wherein the gum base has a tensile strength between 0.25 N/mm.sup.2 and 4 N/mm.sup.2 for using the facial muscles.

4. The composition according to claim 1, wherein the gum base comprises synthetic and/or natural gum as consistency former.

5. The composition according to claim 1, wherein the gum base comprises 0.05 to 0.5 wt %, preferably 0.08 to 0.2 wt %, particularly preferred 0.1 wt % of a trace element.

6. The composition according to claim 5, wherein the trace element is zinc.

7. The composition according to claim 1, wherein the gum base comprises 0.1 wt % to 1 wt %, preferably 0.15 wt % to 0.35 wt %, particularly preferred 0.25 wt % of a salt.

8. The composition according to claim 7, wherein the salt is sodium chloride.

9. The composition according to claim 1, wherein the gum base comprises 0.05 wt % to 0.5 wt %, preferably 0.09 wt % to 0.3 wt %, particularly preferred 0.15 wt % of a vitamin B.

10. The composition according to claim 7, wherein the vitamin B comprises niacin and/or pantothenic acid.

11. The composition according to claim 1, wherein the gum base comprises 0.1 wt % to 1 wt %, preferably 0.2 wt % to 0.4 wt %, particularly preferred 0.3 wt % of a vitamin D.

12. The composition according to claim 11, wherein the vitamin D is biotin.

13. The composition according to claim 1, wherein the gum base further comprises an acidity regulator.

14. The composition according to claim 13, wherein the acidity regulator is citric acid.

15. The composition according to claim 1, wherein the gum base comprises a sugar alcohol.

16. The composition according to claim 2, wherein the gum base has the tensile strength between 0.25 N/mm.sup.2 and 4 N/mm.sup.2 for using the facial muscles.

17. The composition according to claim 2, wherein the gum base comprises synthetic and/or natural gum as consistency former.

18. The composition according to claim 3, wherein the gum base comprises synthetic and/or natural gum as consistency former.

19. The composition according to claim 2, wherein the gum base comprises 0.05 to 0.5 wt %, preferably 0.08 to 0.2 wt %, particularly preferred 0.1 wt % of a trace element.

20. The composition according to claim 3, wherein the gum base comprises 0.05 to 0.5 wt %, preferably 0.08 to 0.2 wt %, particularly preferred 0.1 wt % of a trace element.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The above-described properties, features and advantages of this disclosure, as well as the manner in which they are achieved, will become clearer in connection with the following description of the embodiments, which are explained in more detail in connection with the drawing, in which:

[0021] FIG. 1 is a diagram with mean values plotted over time on positively connoted moods of subjects who took a composition according to the disclosure, according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019,

[0022] FIG. 2 is a diagram with mean values plotted over time on positively connoted moods of subjects who took an alternative composition, according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019,

[0023] FIG. 3 is a diagram with mean values plotted over time on negatively connoted moods of subjects who took a composition according to the disclosure, according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019,

[0024] FIG. 4 is a diagram with mean values plotted over time on negatively connoted moods of subjects who took an alternative composition, according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019,

[0025] FIG. 5 is a diagram showing an evaluation of collected trial data on the “Pleasant-Unpleasant” scale according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019,

[0026] FIG. 6 is a diagram showing an evaluation of collected trial data on the “Excited-Calm” scale according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019,

[0027] FIG. 7 is a diagram showing an evaluation of collected trial data on the “Positive-Tired” scale according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019, and

[0028] FIG. 8 is a diagram showing an evaluation of collected trial data on the “Negative-Relaxed” scale according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019.

DETAILED DESCRIPTION

[0029] In the figures, the same technical elements are provided with the same reference signs, and are only described once.

[0030] The efficacy of the claimed composition was determined using an embodiment example of the claimed composition in a clinical trial and compared to an alternative composition.

[0031] The embodiment example of the claimed composition was a plurality of chewing gums of 2 g each. Each chewing gum contained 1.5 g of a sugar alcohol blend of sorbitol, maltiol and mannitol, a vitamin and mineral blend of 5 mg of salt, 2 mg of zinc, 2 mg of niacin, 0.8 mg of pantothenic acid and 6.5 μg of biotin. Furthermore, 2 mg of citric acid and 6 mg of lavender oil were added to the composition. The rest of each chewing gum were emollients, humectants, antioxidants, flavors, colorants and emulsifiers, which add nothing to the claimed effect of the composition.

[0032] The alternative composition was a variety of tablets. Each tablet contained 50 mg of lavender flower extract, 10 mg of lavender oil, 1.1 mg of vitamin B1, 1.4 mg of vitamin B2, 6 mg of pantothenic acid, 1.4 mg of vitamin B6 and 5 μg of vitamin B12, such as those sold by Queisser Pharma GmbH & Co. KG under the trade name Doppelherz aktiv Lavendel.

[0033] Each tablet of the alternative composition therefore contained approximately twice the lavender extract compared to a chewing gum according to the embodiment example of the claimed composition.

[0034] To collect the clinical trial data, 80 subjects were divided into a group of 40 subjects for taking the chewing gums according to the embodiment example of the claimed composition and a group of 40 subjects for taking the tablets according to the alternative composition. Depending on the group, the subject took one chewing gum according to the embodiment example of the claimed composition or two tablets according to the alternative composition twice a day over a period of 14 days.

[0035] To collect the trial data, the subjects filled out a questionnaire according to the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019, on the first day, the third day, the fifth day, the eighth day, the eleventh day, and the fourteenth day, respectively, with which they provided information about their mood on various scales.

[0036] With each questionnaire, a subject's mood was assessed on sixteen different mood scales. The individual mood scales are defined by the BMIS and a mood scale with which is asked how lively (in BMIS: “Lively”) the subject feels, a mood scale how happy (in BMIS: “Happy”) the subject feels, a mood scale how sad (in BMIS: “Sad”) the subject feels, a mood scale how tired (in BMIS: “Tired”) the subject feels, a mood scale how caring (in BMIS: “Caring”) the subject feels, a mood scale how content (in BMIS: “Content”) the subject feels, a mood scale how gloomy (in BMIS: “Gloomy”) the subject feels, a mood scale how jittery (in BMIS: “Jittery”) the subject feels, a mood scale how drowsy (in BMIS: “Drowsy”) the subject feels, a mood scale how grouchy (in BMIS: “Grouchy”) the subject feels, a mood scale how peppy (in BMIS: “Peppy”) the subject feels, a mood scale how nervous (in BMIS: “Nervous”) the subject feels, a mood scale how calm (in BMIS: “Calm”) the subject feels, a mood scale how loving (in BMIS: “Loving”) the subject feels, a mood scale how fed up (in BMIS: “Fed up”) the subject feels, a mood scale how active (in BMIS: “Active”) the subject feels.

[0037] On each scale, the subject could decide whether the mood of the corresponding scale certainly applied to him, whether the mood of the corresponding scale probably applied to him, whether the mood of the corresponding scale probably did not apply to him, or whether the mood of the corresponding scale certainly did not apply to him. If the mood was certainly true for the subject, the subject's decision was assigned a value of 4. If the mood was probably true for the subject, the subject's decision was assigned a value of 3. If the mood was probably not true for the subject, the subject's decision was assigned a value of 2. If the mood was certainly not true for the subject, the subject's decision was assigned a value of 1.

[0038] The questionnaires were analyzed by first averaging across all participants for each group for each day and for each scale.

[0039] Table 1 below shows the result of this averaging for the group to whom the chewing gums were administered according to the embodiment example of the claimed composition:

TABLE-US-00001 TABLE 1 Day 1 Day 3 Day 5 Day 8 Day Day 14 Lively 2.63 2.68 2.93 2.98 2.98 2.93 Happy 2.78 2.70 2.85 2.97 3.03 2.88 Sad 1.80 2.03 1.93 1.83 1.68 1.80 Tired 2.48 2.38 2.15 2.08 2.15 2.08 Caring 2.65 2.73 2.73 2.85 2.83 2.85 Content 2.78 2.78 2.83 2.95 2.98 3.08 Gloomy 1.90 2.00 1.80 1.78 1.83 1.65 Jittery 1.63 1.55 1.73 1.63 1.55 1.60 Drowsy 2.20 2.38 2.10 2.05 2.03 2.08 Grouchy 1.63 1.65 1.70 1.50 1.68 1.55 Peppy 2.48 2.40 2.60 2.63 2.78 2.73 Nervous 1.93 2.03 1.60 1.70 1.75 1.65 Calm 2.60 2.70 2.90 2.83 3.05 3.08 Loving 2.78 2.75 2.80 2.95 2.98 2.93 Fed up 2.00 2.18 1.90 1.80 1.88 1.78 Active 2.53 2.53 2.78 2.85 2.80 2.80

[0040] In contrast, Table 2 below shows the result of the averaging for the group to whom the tablets were administered according to the alternative composition:

TABLE-US-00002 TABLE 2 Day 1 Day 3 Day 5 Day 8 Day 11 Day 14 Lively 2.78 2.83 2.95 3.08 2.98 3.20 Happy 2.88 2.95 3.13 3.00 2.88 3.13 Sad 1.70 1.73 1.63 1.73 1.88 1.60 Tired 2.25 2.13 1.85 2.00 2.00 1.83 Caring 2.70 2.80 3.00 2.80 2.83 2.90 Content 2.88 2.95 3.18 3.25 2.98 3.15 Gloomy 1.63 1.75 1.75 1.68 1.73 1.65 Jittery 1.50 1.55 1.53 1.48 1.63 1.60 Drowsy 2.23 2.23 1.98 2.13 2.18 1.98 Grouchy 1.68 1.60 1.45 1.55 1.53 1.48 Peppy 2.58 2.60 2.78 2.75 2.55 2.78 Nervous 1.68 1.78 1.68 1.78 1.80 1.73 Calm 2.80 2.95 3.05 3.00 2.98 3.10 Loving 2.83 2.98 3.05 3.00 2.95 3.03 Fed up 1.90 1.80 1.80 1.89 1.80 1.76 Active 2.63 2.78 2.93 2.83 2.73 2.80

[0041] The values 1 from tables 1 and 2 are plotted against time 2 in FIGS. 1 to 4. FIG. 1 shows the values 1 of the positively connoted mood scales of table 1. These are the mood scales lively 4, happy 6, caring 7, content 8, peppy 10, calm 12, loving 14, and active 16. In FIG. 2, the same positively connoted mood scales are plotted, but from Table 2.

[0042] FIG. 3 shows the values 1 of the negatively connoted mood scales of Table 1. These are the mood scales sad 18, tired 20, gloomy 22, jittery 24, drowsy 25, grouchy 26, nervous 28, and fed up 30. In FIG. 4, the same negatively connoted mood scales are plotted, but from Table 2.

[0043] FIGS. 1 and 2 show that all stimulating mood scales show a positive trend, both for the claimed composition and for the alternative composition. Significant in the single evaluation of the claimed composition is the mood scale calm 12 and of the alternative composition the mood scale lively 4. Pooling the subject groups of both compositions additionally results in a significant improvement for the mood scale satisfied 8.

[0044] The moods belonging to the mood scales in FIGS. 1 and 2 are perceived as pleasant and stimulating and positive, as shown in Table 1.1 of the Brief Mood Introspection Scale, abbreviated BMIS, 3.sup.rd edition, Feb. 26, 2019. It was possible to increase all of these positive moods either in trend or significantly with both the claimed composition and the alternative composition.

[0045] FIGS. 3 and 4 show that all inhibitory mood scales show a constant trend, both for the claimed composition and for the alternative composition. Significant in the individual evaluation is even a decreasing trend of fatigue 20 with the claimed composition, which is not so recognizable with the alternative composition. The subjects were more alert and able to concentrate better.

[0046] Then, for further evaluation, a value on the four subscales according to BMIS was calculated from the mean values for each day, i.e., a daily value on the satisfaction scale (according to BMIS: “Pleasant-Unpleasant”), a daily value on the arousal scale (according to BMIS: “Arousal-Calm”), a daily value on the fatigue scale (according to BMIS: “Positive-Tired”), and a daily value on the relaxation scale (according to BMIS: “Negative-Relaxed”).

[0047] Table 3 below shows the values for the subscales for the group that was administered the chewing gums according to the embodiment example of the claimed composition:

TABLE-US-00003 TABLE 3 Day 1 Day 3 Day 5 Day 8 Day 11 Day 14 Pleasant - 5.7 5.1 7.5 8.65 8.9 9.1 Unpleasant Excited - 17.2 17.8 17.7 18.1 17.8 17.6 Calm Positive - 8.4 8.3 9.6 10.1 10.2 10.1 Tired Negative - 6.7 7.1 6.1 5.9 5.6 5.4 Relaxed

[0048] In contrast, Table 4 below shows the values for the subscales for the group that was administered the tablets according to the alternative composition:

TABLE-US-00004 TABLE 4 Day 1 Day 3 Day 5 Day 8 Day 11 Day 14 Pleasant - 7.5 8.3 10.4 9.5 8.3 10.5 Unpleasant Excited - 16.9 17.5 18.2 18.0 17.9 18.1 Calm Positive - 9.0 9.6 10.9 10.3 9.9 10.9 Tired Negative - 5.6 5.7 5.3 5.6 5.9 5.2 Relaxed

[0049] The values thus calculated for the subscales are plotted against time 2 in the diagrams shown in FIGS. 5 to 8 to evaluate the result. The diagram of FIG. 5 shows over time 2 on the satisfaction scale 34 (according to BMIS: “Pleasant-Unpleasant”), a chewing gum satisfaction curve 36 with the daily values for the chewing gums according to the embodiment example of the claimed composition and a tablet satisfaction curve 38 with the daily values for the tablets according to the alternative composition. The diagram of FIG. 6 shows over time 2 on the arousal scale 44 (according to BMIS: “Arousal-Calm”), a chewing gum arousal curve 46 with the daily values for the chewing gums according to the embodiment example of the claimed composition and a tablet arousal curve 48 with the daily values for the tablets according to the alternative composition. The diagram of FIG. 7 shows over time 2 on the fatigue scale 54 (according to BMIS: “Positive-Tired”), a chewing gum fatigue curve 56 with the daily values for the chewing gums according to the embodiment example of the claimed composition and a tablet fatigue curve 58 with the daily values for the tablets according to the alternative composition. The diagram of FIG. 8 shows over time 2 on the relaxation scale 64 (according to BMIS: “Negative-Relaxed”), a chewing gum relaxation curve 66 with the daily values for the chewing gums according to the embodiment example of the claimed composition and a tablet relaxation curve 68 with the daily values for the tablets according to the alternative composition.

[0050] The curves of FIGS. 5 to 8 support the result interpreted from FIGS. 1 to 4 that both compositions lower negative moods or at least keep them constant and increase positive moods. The subjects felt more alert and were more attentive.