Products for treating and / or preventing menstrual symptoms

Abstract

1. A composition for use in the treatment and / or prevention of menstrual symptoms, comprising: (i) fennel and chamomile; or (ii) fennel, ginger and lemon balm.

Description

[Technical field]

[0001] The present invention relates to compositions for use in the treatment and / or prevention of menstrual symptoms. In particular, the present invention relates to confectionery products comprising botanicals and the use of said products for the treatment and / or prevention of menstrual symptoms. [Background technology] Menstrual symptoms have an undesirable effect on a significant proportion of women. It is estimated that 60-85% of women are affected by (pre)menstrual symptoms, which can lead to reduced productivity, recurrent pain, and habitual absenteeism from school. Premenstruation may be accompanied by mood-related symptoms, bloating, and discomfort. Menstruation may be accompanied by cramps and fatigue.

[0002] Pharmaceutically based approaches to relieving (premenstrual) symptoms may have side effects. Furthermore, it is recognized that some individuals may prefer alternative non-pharmaceutical approaches. In this regard, various botanical ingredients have been reported to relieve one or more (premenstrual) symptoms.

[0003] Thus, there is a need for compositions and products that are effective in relieving (pre)menstrual symptoms, particularly those compositions and products that are alternatives to pharmaceutical-based approaches.

[0004] [Summary of the Invention] The present invention relates to a composition comprising a botanical ingredient for use in the treatment and / or prevention of one or more (pre)menstrual symptoms. In particular, the composition may be a confectionery product as provided herein.

[0005] In one embodiment, the premenstrual symptom is fatigue. In one embodiment, the premenstrual symptom is mood swings. In one embodiment, the premenstrual symptom is overeating or cravings. In one embodiment, the premenstrual symptom is headaches. In one embodiment, the premenstrual symptom is abdominal cramps.

[0006] Thus, in one aspect, the present invention provides a composition for use in the treatment and / or prevention of menstrual symptoms, the composition comprising fennel and chamomile.

[0007] In one embodiment, the menstrual symptom is abdominal cramps. In one embodiment, the menstrual symptom is fatigue. In one embodiment, the menstrual symptom is mood swings. In one embodiment, the menstrual symptom is bloating. In one embodiment, the menstrual symptom is back pain.

[0008] The present invention also provides a composition for use in the treatment and / or prevention of menstrual symptoms, the composition comprising fennel, ginger and lemon balm.

[0009] The present invention further includes a combination of a first composition comprising fennel and chamomile and a second composition comprising fennel, ginger and lemon balm for use in the treatment and / or prevention of menstrual symptoms.

[0010] In another aspect, the invention relates to a method of treating and / or preventing menstrual symptoms comprising administering to a subject a composition comprising fennel and chamomile.

[0011] The present invention further provides a method of treating and / or preventing menstrual symptoms comprising administering to a subject a composition comprising fennel, ginger, and lemon balm.

[0012] The present invention also relates to the use of a combination of fennel and chamomile in the manufacture of a medicament for treating and / or preventing menstrual symptoms.

[0013] The present invention further provides the use of a combination of fennel, ginger and lemon balm in the manufacture of a medicament for the treatment and / or prevention of menstrual symptoms.

[0014] The present invention also provides a product, preferably a confectionery product, comprising fennel and chamomile.

[0015] The present invention further provides a product, preferably a confectionery product, comprising fennel, ginger and lemon balm.

[0016] The invention also provides a kit comprising a first product, preferably a confectionery product, comprising fennel and chamomile, and a second product, preferably a confectionery product, comprising fennel, ginger and lemon balm.

[0017] The invention further provides a method for preparing a confectionery product according to the invention comprising the steps of: a) providing a powder mix comprising: (i) fennel extract powder or dried fennel powder and chamomile extract powder or dried chamomile powder; or (ii) fennel extract powder or dried fennel powder, ginger extract powder or dried ginger powder, and lemon balm extract powder or dried lemon balm powder; b) combining and mixing the powder mix with a dough mix to form a combined dough; and c) molding or shaping the combined dough to form a confectionery mass.

[0018] Suitably, other botanical ingredients may be used as substitutes for the botanical ingredients described herein.For example, cinnamon may be provided as a substitute for ginger, and sage may be provided as a substitute for chamomile and / or lemon balm.Raspberry leaves may also be provided as substitute botanical ingredients that can relieve menstrual pain.Thus, the composition or product for use of the present invention may include substitute botanical ingredients such as one or more of the above. [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 is a schematic diagram illustrating an exemplary process for making the confectionery products of the present invention. [Diagram 2]In Figure 2, the graph on the left shows the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graph on the right). [Diagram 3] In Figure 3, the graph on the left shows the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graph on the right). [Figure 4] In Figure 4, the graph on the left shows the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graph on the right). [Diagram 5] In Figure 5, the graph on the left shows the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graph on the right). [Figure 6] In Figure 6, the graph on the left shows the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graph on the right). [Figure 7] In Figure 7, the graph on the left shows the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graph on the right). [Figure 8]In Figure 8, the graph on the left shows the severity of various symptoms during menstrual periods before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after ingesting one cycle of a bite-sized snack (graph on the right). [Figure 9] In FIG. 9, the graph on the left shows the severity of various symptoms during menstrual periods before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after ingesting one cycle of a bite-sized snack (graph on the right). [Figure 10] In Figure 10, the graph on the left shows the severity of various symptoms during menstrual periods before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after ingesting one cycle of a bite-sized snack (graph on the right). [Figure 11] In FIG. 11, the graph on the left shows the severity of various symptoms during menstrual periods before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after ingesting one cycle of a bite-sized snack (graph on the right). [Figure 12] In FIG. 12, the graph on the left shows the severity of various symptoms during menstrual periods before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after ingesting one cycle of a bite-sized snack (graph on the right). [Figure 13] In FIG. 13, the graph on the left shows the severity of various symptoms during menstrual periods before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bar on the left) and after ingestion (bar on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after ingesting one cycle of a bite-sized snack (graph on the right).

[0020] [Mode for carrying out the invention] The present invention relates to compositions comprising botanicals for use in the treatment and / or prevention of one or more (pre)menstrual symptoms.

[0021] Menstruation Menstruation is the regular discharge of blood and mucosal tissue from the lining of the uterus through the vagina. The menstrual cycle is characterized by the rise and fall of hormones. Menstruation occurs when progesterone levels fall and is a sign that pregnancy is not occurring.

[0022] Symptoms that precede menstruation and interfere with normal life are sometimes called premenstrual syndrome (PMS). PMS can include acne, breast tenderness, bloating, fatigue, irritability, and mood changes. Other symptoms experienced by some women include painful and heavy bleeding during menstruation, as well as irregular bleeding at any time during the menstrual cycle.

[0023] Premenstrual can refer to the period before menstruation begins.For example, premenstrual can refer to up to 7 days, up to 5 days, or up to 3 days before menstruation begins.Premenstrual can be accompanied by mood-related symptoms, bloating, and discomfort.Premenstrual symptoms can be assessed (e.g., before and after administration of the composition or product of the present invention) using a Premenstrual Symptom Screening Tool.

[0024] Menstruation may refer to the period after the onset of menstruation. Menstruation may be accompanied by symptoms such as cramps and fatigue. Menstrual symptoms may be assessed using a Pain Visual Analogue Scale (PVAS) or a pain numeric scale (e.g., before and after administration of the composition or product of the present invention).

[0025] Premenstrual and / or menstrual symptoms may be assessed using the SF36 questionnaire (www.rand.org / health-care / surveys_tools / mos / 36-item-short-form).

[0026] The compositions or products for use according to the invention may reduce one or more premenstrual or menstrual symptoms. The premenstrual or menstrual symptom(s) and level of symptoms may be measured using the methods described herein.

[0027] In one aspect, the premenstrual symptom is fatigue. In one aspect, the premenstrual symptom is mood swings. In one aspect, the premenstrual symptom is overeating or cravings. In one aspect, the premenstrual symptom is headache. In one aspect, the premenstrual symptom is abdominal cramps.

[0028] In one embodiment, the menstrual symptom is abdominal cramps. In one embodiment, the menstrual symptom is fatigue. In one embodiment, the menstrual symptom is mood swings. In one embodiment, the menstrual symptom is bloating. In one embodiment, the menstrual symptom is back pain.

[0029] The composition or product for use may reduce one or more behavioral, psychological and / or physical premenstrual symptoms. In particular, the composition or product for use comprising fennel and chamomile provided herein may reduce one or more behavioral, psychological and / or physical premenstrual symptoms.

[0030] The composition or product may reduce one or more behavioral, psychological and / or physical menstrual symptoms. In particular, the compositions or products for use comprising fennel, ginger and lemon balm provided herein may reduce one or more behavioral, psychological and / or physical premenstrual symptoms.

[0031] The combination compositions or products for use described herein may reduce one or more behavioral, psychological and / or physical premenstrual and menstrual symptoms.

[0032] Fennel Fennel (Foeniculum Vulgare) is a yellow-flowering perennial, fragrant herb that has been used medicinally. As used herein, "fennel" preferably refers to the fruit / seed (i.e., whole bicarp and segmen).

[0033] Fennel for use in the present invention can be obtained from any part of fennel plant, for example from fennel seed.Preferably, fennel for use in the present invention is dried fennel seed, for example in powder form.Preferably, fennel for use in the present invention can be in the form of fennel extract, for example fennel extract powder.Preferably, fennel extract can be fennel seed extract.Fennel extract can be food grade extract.

[0034] Fennel (e.g., dried ground fennel seeds) may be extracted, for example, with water, ethanol, methanol, and / or glycerol as solvent, or with supercritical carbon dioxide. Preferably, the fennel for use in the present invention is a water extract of fennel seeds. Suitable methods for preparing fennel extracts are described, for example, in Angelov, G. and Boyadzhieva, S., 2016. Chemical and Biochemical Engineering Quarterly, 30(2), pp. 245-253 and Damjanovic, B., et al., 2005. Food Chemistry, 92(1), pp. 143-149.

[0035] Preferably, the fennel for use in the present invention is fennel extract powder. The fennel extract may be dried (e.g., spray-dried or freeze-dried) to obtain a powder form. Preferably, the fennel extract is spray-dried. Any suitable carrier may be used for spray-drying (e.g., maltodextrin).

[0036] The composition for use according to the invention may be administered to a subject to provide a daily dose of 0.05g to 2.0g of fennel extract or dried fennel powder. Suitably, the composition may provide a daily dose of 0.05g to 2.0g, 0.05g to 1.0g, 0.1g to 1.0g, 0.1 to 0.5g, 0.1 to 0.4g, 0.1 to 0.3g or 0.2 to 0.3g of fennel extract or dried fennel powder.

[0037] Preferably, the composition may be administered to a subject to provide a daily dose of about 0.2 g to about 0.3 g of fennel extract or dried fennel powder.

[0038] Suitably, the composition may be administered to a subject to provide a daily dose of about 0.20g, about 0.21g, about 0.22g, about 0.23g, about 0.24g, about 0.25g, about 0.26g, about 0.27g, about 0.28g, about 0.29g, about 0.30g of fennel extract or dry fennel powder. Suitably, the composition may be administered to a subject to provide a daily dose of about 0.25g of fennel extract or dry fennel powder.

[0039] chamomile Chamomile belongs to the Asteraceae / Compositae family and is represented by two common species, namely German chamomile (Chamomilla recutita or Matricaria chamomilla) and Roman chamomile (Chamaemelum nobile). Preferably, the chamomile used in the present invention is German chamomile. Dried chamomile flowers contain terpenoids and flavonoids. Chamomile preparations have been described for use in diseases such as hay fever, inflammation, muscle spasms, menstrual disorders, insomnia, ulcers, wounds, gastrointestinal disorders, rheumatic pain, and hemorrhoids.

[0040] Chamomile for use in the present invention can be obtained from any part of chamomile plant, for example from chamomile flower.Preferably, chamomile for use in the present invention is dried chamomile flower, for example in powder form.Preferably, chamomile for use in the present invention can be chamomile extract, for example chamomile extract powder.Preferably, chamomile extract can be chamomile flower extract.Chamomile extract can be food grade extract.

[0041] Chamomile (e.g., dried ground flowers of chamomile) may be extracted, for example, with water, ethanol, methanol and / or glycerol as a solvent, or with supercritical carbon dioxide. Preferably, the chamomile for use in the present invention is a water extract of chamomile flowers. Suitable processes for preparing chamomile extracts are described, for example, in Zlabur JS, et al. Molecules. 2020 Jan;25(4):810 and Scalia, S., et al., 1999. Journal of pharmaceutical and biomedical analysis, 21(3), pp.549-558.

[0042] Preferably, the chamomile used in the present invention is chamomile extract powder. The chamomile extract may be dried (e.g., spray-dried or freeze-dried) to obtain a powder form. Preferably, the chamomile extract is spray-dried. Any suitable carrier may be used for spray-drying (e.g., maltodextrin).

[0043] The composition for use according to the invention may be administered to a subject to provide a daily dose of about 0.1 g to 5.0 g of chamomile extract or dry chamomile powder. Suitably, the composition may provide a daily dose of 0.1 g to 5.0 g, 0.1 g to 4.0 g, 0.2 to 4.0 g, 0.5 to 4.0 g, 0.5 to 3.0 g, 0.5 to 2.0 g or 0.5 to 1.0 g of chamomile extract or dry chamomile powder. Preferably, the composition may provide a daily dose of about 0.5 g to about 2.0 g of chamomile extract. Suitably, the composition may provide a daily dose of about 0.50 g, about 0.60 g, about 0.70 g, about 0.80 g, about 0.90 g, about 1.0 g of chamomile extract or dry chamomile powder. Suitably, the composition may provide a daily dose of about 0.85 g of chamomile extract or dry chamomile powder.

[0044] Ginger Ginger (Zingiber officinale) is a flowering plant whose rhizome, ginger rhizome, is widely used as a spice and medicine.

[0045] Ginger for use in the present invention can be obtained from any part of the ginger plant, for example from ginger root.Preferably, ginger for use in the present invention is dried ginger root, for example in the form of powder.Preferably, ginger for use in the present invention can be ginger extract, for example ginger extract powder.Preferably, ginger extract can be ginger root extract.Ginger extract can be food grade extract.

[0046] Ginger (e.g., dried ground ginger root) may be extracted, for example, using water, ethanol, methanol and / or glycerol as a solvent, or using supercritical carbon dioxide. Preferably, the ginger used in the present invention is a water extract of ginger root. Suitable methods for preparing ginger extracts are described, for example, in Prakash, J., 2010. Journal of Medicinal Plants Research, 4(24), pp. 2674-2679 and Mesomo, MC, et al., 2013. The Journal of Supercritical Fluids, 80, pp. 44-49.

[0047] Preferably, the ginger used in the present invention is ginger extract powder. The ginger extract may be dried (e.g., spray-dried or freeze-dried) to obtain a powder form. Preferably, the ginger extract is spray-dried. Any suitable carrier may be used for spray-drying (e.g., maltodextrin).

[0048] The composition for use according to the invention may be administered to a subject to provide a daily dose of about 0.1 g to 5.0 g of ginger extract or dried ginger powder. Suitably, the composition may provide a daily dose of 0.1 g to 5.0 g, 0.1 g to 4.0 g, 0.2 to 4.0 g, 0.5 to 4.0 g, 0.5 to 3.0 g, 0.5 to 2.0 g or 0.5 to 2.0 g of ginger extract or dried ginger powder. Preferably, the composition may provide a daily dose of about 0.5 g to about 1.0 g of ginger extract or dried ginger powder. Suitably, the composition may provide a daily dose of about 0.50 g, about 0.60 g, about 0.70 g, about 0.80 g, about 0.90 g, about 1.0 g of ginger extract or dried ginger powder. Suitably, the composition may provide a daily dose of about 0.9 g of ginger extract or dried ginger powder.

[0049] Lemon Balm Lemon balm (Melissa officinalis) is a perennial herbaceous plant in the mint family. Lemon balm tea leaves, essential oils, and extracts are used in traditional and alternative medicines, including aromatherapy.

[0050] The lemon balm for use in the present invention can be obtained from any part of the lemon balm plant, for example from lemon balm leaves.Preferably, the lemon balm for use in the present invention is dried lemon balm leaves, for example in the form of powder.Preferably, the lemon balm for use in the present invention can be a lemon balm extract, for example a lemon balm extract powder.Preferably, the lemon balm extract can be a lemon balm leaf extract.The lemon balm extract can be a food grade extract.

[0051] Lemon balm (e.g., dried ground lemon balm leaves) may be extracted, for example, with water, ethanol, methanol and / or glycerol as solvent, or with supercritical carbon dioxide.Preferably, the lemon balm for use in the present invention is a water extract of lemon balm leaves.Suitable methods for preparing lemon balm extracts are described, for example, in Arceusz, A., et al., 2015. Natural product communications, 10(6), pp.977-981.Bogdanovic, A., et al., 2016. The Journal of Supercritical Fluids, 107, pp.234-242.

[0052] Preferably, the lemon balm for use in the present invention is lemon balm extract powder.The lemon balm extract may be dried (e.g., spray-dried or freeze-dried) to obtain a powder form.Preferably, the lemon balm extract is spray-dried.Any suitable carrier can be used for spray-drying (e.g., maltodextrin).

[0053] The composition for use according to the invention may be administered to a subject to provide a daily dose of about 0.1 g to 5.0 g of lemon balm extract or dried lemon balm powder. Suitably, the composition may provide a daily dose of 0.1 g to 5.0 g, 0.1 g to 4.0 g, 0.2 to 4.0 g, 0.5 to 4.0 g, 0.5 to 3.0 g, 0.5 to 2.0 g or 0.5 to 2.0 g of lemon balm extract or dried lemon balm powder. Preferably, the composition may provide a daily dose of about 0.5 g to about 1.0 g of lemon balm extract or dried lemon balm powder. Suitably, the composition may provide a daily dose of about 0.50 g, about 0.60 g, about 0.70 g, about 0.80 g, about 0.90 g, about 1.0 g of lemon balm extract or dried lemon balm powder. Suitably, the composition may provide a daily dose of about 0.9 g of lemon balm extract or dried lemon balm powder.

[0054] magnesium Magnesium has been reported to reduce anxiety and / or depression.

[0055] Suitably the magnesium is food grade magnesium.

[0056] The compositions for use according to the invention may be administered to a subject to provide a daily dose of magnesium of about 10-460mg, 10-400mg, 10-300mg, 25-300mg, 25-200mg, 50-200mg or 50-100mg. Suitably, the compositions may provide a daily dose of magnesium of about 50mg, about 70mg or about 100mg. Suitably, the compositions may provide a daily dose of magnesium of about 70mg.

[0057] iron Compositions for use according to the invention may be administered to a subject to provide a daily dose of about 1-20 mg, 1-10 mg, 1-5 mg, 1-4 mg, 1-3 mg, or 2-3 mg of iron. Suitably, the compositions may provide a daily dose of about 2.0 mg, about 2.2 mg, about 2.4 mg, about 2.6 mg, about 2.8 mg, or about 3.0 mg of iron. Suitably, the compositions may provide a daily dose of about 2.6 mg or about 2.8 mg of iron.

[0058] Suitably the iron is food grade iron.

[0059] composition The composition for use according to the invention may be administered to a subject to provide a daily dose of about 0.1-0.3 g of fennel extract or dried fennel powder, and about 0.5-2.0 g of chamomile extract or dried chamomile powder. The composition may be administered to provide a daily dose of about 0.1-0.3 g of fennel extract or dried fennel powder, about 0.5-1.0 g of chamomile extract or dried chamomile powder, and about 35-100 mg of magnesium. The composition may be administered to provide a daily dose of about 0.25 g of fennel extract or dried fennel powder, and about 0.85 g of chamomile extract or dried chamomile powder. The composition may be administered to provide a daily dose of about 0.25 g of fennel extract or dried fennel powder, about 0.85 g of chamomile extract or dried chamomile powder, and about 70 mg of magnesium. Preferably, the fennel is a fennel extract. Preferably, the chamomile is a chamomile extract.

[0060] Compositions for use according to the invention may be administered to a subject to provide a daily dose of about 0.1-0.3g of fennel extract or dried fennel powder, about 0.25g-2.0g of ginger extract or dried ginger powder, and about 0.25g-2.0g of lemon balm extract or dried lemon balm powder. Compositions may be administered to provide a daily dose of about 0.25g of fennel extract or dried fennel powder, about 0.9g of ginger extract or dried ginger powder, and about 0.9g of lemon balm extract or dried lemon balm powder.

[0061] Preferably, the fennel is a fennel extract. Preferably, the chamomile is a chamomile extract. Preferably, the lemon balm is a lemon balm extract.

[0062] The present invention also relates to the use of a composition comprising fennel and chamomile for reducing one or more (pre)menstrual symptoms. The composition may be a product comprising fennel and chamomile as provided herein.

[0063] In one aspect, the premenstrual symptom is fatigue. In one aspect, the premenstrual symptom is mood swings. In one aspect, the premenstrual symptom is overeating or cravings. In one aspect, the premenstrual symptom is headache. In one aspect, the premenstrual symptom is abdominal cramps.

[0064] The present invention also relates to the use of a composition comprising fennel, ginger and lemon balm for reducing one or more (pre)menstrual symptoms. The composition may be a product comprising fennel, ginger and lemon balm as provided herein.

[0065] In one embodiment, the menstrual symptom is abdominal cramps. In one embodiment, the menstrual symptom is fatigue. In one embodiment, the menstrual symptom is mood swings. In one embodiment, the menstrual symptom is bloating. In one embodiment, the menstrual symptom is back pain.

[0066] Without wishing to be bound by theory, it is believed that the combination of fennel with chamomile, and / or the combination of fennel with ginger and lemon balm is particularly advantageous as such combinations of botanical ingredients may provide relief from at least two different symptoms of (pre)menstrual symptoms.

[0067] Administration Compositions for use according to the invention may be administered in any suitable manner. Preferably, the compositions are for oral administration.

[0068] The composition for use in the treatment and / or prevention of premenstrual symptoms may be administered before the onset of menstruation. Preferably, the composition for use in the treatment and / or prevention of premenstrual symptoms is a composition comprising fennel and chamomile as defined herein.

[0069] The composition may be administered from 3 to 7 days prior to the onset of menstruation. For example, the composition may be administered for 3 to 7 days prior to the onset of menstruation. Preferably, the composition is administered daily for 3 to 7 days prior to the onset of menstruation. Preferably, the composition is administered daily for 3, 4, 5, 6 or 7 days prior to the onset of menstruation. Preferably, the composition is administered daily for 5 days prior to the onset of menstruation.

[0070] The composition for use in the treatment and / or prevention of menstrual symptoms may be administered after the onset of menstruation. Preferably, the composition for use in the treatment and / or prevention of menstrual symptoms is a composition comprising fennel, ginger and lemon balm as defined herein.

[0071] The composition may be administered from 3 to 7 days after the onset of menstruation. For example, the composition may be administered for 3 to 7 days after the onset of menstruation. Preferably, the composition is administered daily for 3 to 7 days after the onset of menstruation. Preferably, the composition is administered daily for 3, 4, 5, 6 or 7 days after the onset of menstruation. Preferably, the composition is administered daily for 5 days after the onset of menstruation. The composition may be initially administered on the day of or after the onset of menstruation.

[0072] A composition for use in the treatment and / or prevention of premenstrual symptoms and a composition for use in the treatment and / or prevention of menstrual symptoms may be used in combination, in particular a composition for use in the treatment and / or prevention of premenstrual symptoms may be administered before the onset of menstruation, followed by a composition for use in the treatment and / or prevention of menstrual symptoms after the onset of menstruation.

[0073] A composition comprising fennel and chamomile for use in the treatment and / or prevention of premenstrual symptoms and / or a composition comprising fennel, ginger and lemon balm for use in the treatment and / or prevention of menstrual symptoms may be administered as described herein.

[0074] The composition or combination of compositions may be administered over at least one menstrual cycle. The composition or combination of compositions may be administered over at least 1, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11, or at least 12 menstrual cycles.

[0075] subject The subject according to the present invention is a female having an active menstrual cycle. Preferably, the subject is a human.

[0076] The subject may be aged 15-65 years, 15-55 years, 15-45 years, or 15-35 years.

[0077] product In one aspect, the present invention provides a product comprising fennel and chamomile.

[0078] In another aspect, the present invention provides a product comprising fennel, ginger and lemon balm.

[0079] The product may be a confectionery product (eg, a confectionery bite, a bar, a chocolate), a powder for dissolving in a beverage, or a beverage.

[0080] Preferably the product is a confectionery product.

[0081] The product may contain about 0.05g to 2.0g, 0.05g to 1.0g, or 0.05g to 0.25g of fennel extract or dry fennel powder. The product may contain 0.05g to 2.0g, 0.05g to 1.0g, 0.1g to 1.0g, 0.1 to 0.5g, 0.1 to 0.4g, or 0.1 to 0.3g of fennel extract or dry fennel powder. The product may contain 0.05g to 0.50g, 0.05g to 0.40g, 0.10g to 0.40g, 0.20g to 0.30g, or 0.10g to 0.20g of fennel extract or dry fennel powder. The product may contain 0.05g-0.25g, 0.05g-0.20g, or 0.10g-0.20g of fennel extract or dry fennel powder. The product may contain about 0.10g, about 0.15g, or about 0.20g of fennel extract or dry fennel powder. The product may contain about 0.10g, about 0.11g, about 0.12g, about 0.13g, about 0.14g, about 0.15g, about 0.16g, about 0.17g, about 0.18g, about 0.19g, about 0.20g of fennel extract or dry fennel powder. The product may contain about 0.125g of fennel extract or dry fennel powder. Preferably, the fennel is fennel extract.

[0082] The product may contain about 0.1g to 5.0g of chamomile extract or dry chamomile powder. Preferably, the product may contain 0.1g to 5.0g, 0.1g to 4.0g, 0.2 to 4.0g, 0.5 to 4.0g, 0.5 to 3.0g, 0.5 to 2.0g, or 0.5 to 1.0g of chamomile extract or dry chamomile powder. Preferably, the product may contain about 0.5g to about 2.0g of chamomile extract or dry chamomile powder. Preferably, the product may contain about 0.50g, about 0.60g, about 0.70g, about 0.80g, about 0.90g, or about 1.0g of chamomile extract or dry chamomile powder. Preferably, the product may contain about 0.85g of chamomile extract or dry chamomile powder. Suitably, the product may contain about 0.425g of chamomile extract or dried chamomile powder. Preferably, the chamomile is chamomile extract.

[0083] The product may contain about 0.1g to 5.0g of ginger extract or dried ginger powder. Preferably, the product may contain 0.1g to 5.0g, 0.1g to 4.0g, 0.2 to 4.0g, 0.5 to 4.0g, 0.5 to 3.0g, 0.5 to 2.0g, or 0.5 to 1.0g of ginger extract or dried ginger powder. Preferably, the product may contain about 0.5g to about 2.0g of ginger extract or dried ginger powder. Preferably, the product may contain about 0.50g, about 0.60g, about 0.70g, about 0.80g, about 0.90g, or about 1.0g of ginger extract or dried ginger powder. Preferably, the product may contain about 0.85g of ginger extract or dried ginger powder. Preferably, the product may contain about 0.45g of ginger extract or dried ginger powder. Preferably the ginger is a ginger extract.

[0084] The product may contain about 0.1g to 5.0g of lemon balm extract or dried lemon balm powder. Preferably, the product may contain 0.1g to 5.0g, 0.1g to 4.0g, 0.2 to 4.0g, 0.5 to 4.0g, 0.5 to 3.0g, 0.5 to 2.0g or 0.5 to 1.0g of lemon balm extract or dried lemon balm powder. Preferably, the product may contain about 0.5g to about 2.0g of lemon balm extract or dried lemon balm powder. Preferably, the product may contain about 0.50g, about 0.60g, about 0.70g, about 0.80g, about 0.90g, about 1.0g of lemon balm extract or dried lemon balm powder. Preferably, the product may contain about 0.85g of lemon balm or dried lemon balm powder. Suitably, the product may contain about 0.45 g of lemon balm extract or dried lemon balm powder. Preferably, the lemon balm is lemon balm extract.

[0085] The product may contain about 10-460mg, 10-400mg, 10-300mg, 25-300mg, 25-200mg, 25-200mg, 50-200mg, 25-100mg, or 50-100mg of magnesium. Preferably, the product may contain about 35mg, about 50mg, about 70mg, or about 100mg of magnesium. Preferably, the product may contain about 70mg of magnesium. Preferably, the product may contain about 35mg of magnesium.

[0086] The product may contain about 0.1-0.3g of fennel extract or dried fennel powder, about 0.5-1.0g of chamomile extract or dried chamomile powder. The product may contain about 0.1-0.3g of fennel extract or dried fennel powder, about 0.5-2.0g of chamomile extract or dried chamomile powder, and about 35-100mg of magnesium. The product may contain about 0.125g of fennel extract or dried fennel powder, about 0.425g of chamomile extract or dried chamomile powder, and about 35mg of magnesium.

[0087] The product may comprise about 0.1-0.3g of fennel extract or dried fennel powder, about 0.25g-1.0g of ginger extract or dried ginger powder, and about 0.25g-1.0g of lemon balm extract or dried lemon balm powder.The product may comprise about 0.125g of fennel extract or dried fennel powder, about 0.45g of ginger extract or dried ginger powder, and about 0.45g of lemon balm extract or dried lemon balm powder.

[0088] The product may contain iron. For example, the product may contain about 1-20 mg, 1-15 mg, 1-10 mg, 1-5 mg, or 1-3 mg of iron. Preferably, the product may contain about 1 mg, about 2 mg, or about 3 mg of iron. Preferably, the product may contain about 2.0 mg, about 2.2 mg, about 2.4 mg, about 2.6 mg, about 2.8 mg, or about 3.0 mg of iron. Preferably, the product may contain about 2.6 mg or about 2.8 mg of iron.

[0089] Preferably the product is a confectionery product.

[0090] The confectionery product may be a bite-sized confectionery. As used herein, a bite-sized confectionery refers to a confectionery that is intended or suitable for consumption in one or two bites. For example, the bite-sized confectionery may be similar in size to a truffle or brigadeiro.

[0091] Suitably the morsels may be spherical, circular, square, rectangular or star shaped. Suitably the morsels are spherical.

[0092] The confectionery product may be provided in any suitable confectionery form. The confectionery product may be a solid confectionery mass.

[0093] Suitably, the product (e.g., confectionery product) has a water activity of less than 0.6. w) is the partial vapor pressure of water in a solution divided by the partial vapor pressure of water at standard state. In food science, standard state is most often defined as the partial vapor pressure of pure water at the same temperature. Using this definition, pure distilled water has a water activity of exactly 1. Thus, confectionery products may have a water activity of less than 0.6 at temperatures where pure distilled water has a water activity of exactly 1. Water activity may be measured at room temperature, for example, from about 20° C. to about 22° C. Water activity may be measured using methods known in the art, for example, using resistive electrolytic, capacitance or dew point meters.

[0094] The product (eg, a confectionery product) may include cocoa and / or fruit flavors.

[0095] The cocoa may be in the form of cocoa powder.

[0096] The fruit flavour may be raspberry, passion fruit, orange, cranberry, banana or strawberry fruit flavour. The fruit flavour may be in the form of a fruit powder.

[0097] A product, such as a confectionery product, may include a combination of botanical ingredients and cocoa and fruit flavors as described herein in a matrix. A confectionery product, such as a confectionery product, may include a dough that includes cocoa and / or fruit flavors in combination with botanical ingredients as described herein.

[0098] Without wishing to be bound by theory, it is believed that providing the plant ingredient in such a food matrix (e.g., a matrix that includes the plant ingredient in combination with lipids and sugars) may provide beneficial effects with respect to the efficacy and / or bioavailability of the plant ingredient, which may be further enhanced by the inclusion of, for example, magnesium and / or iron.

[0099] The composition or product, e.g., confectionery product, may provide about 50-500 kcal, about 50-300 kcal, about 50-200 kcal, about 100-200 kcal, or about 150-200 kcal per portion. Preferably, the composition or product provides about 150 to about 200 kcal per portion.

[0100] The composition or product, e.g., confectionery product, may comprise about 5-20g, about 5-15g, about 5-12g, about 7-12g or about 7-10g of total fat per portion. Preferably, the composition or product may comprise about 7g to about 10g of total fat per portion.

[0101] The composition or product, e.g., confectionery product, may contain about 0.25-5g, about 0.25-3, about 0.5-3g, about 1-3g, about 1.5-3g or about 1.5-2g of saturated fat per portion. Preferably, the composition or product may contain about 1.5g to about 2g of saturated fat per portion.

[0102] The composition or product, e.g., confectionery product, may comprise about 5-100g, about 5-75g, about 5-50g, about 10-50g, about 10-25g, or about 15-25g of total carbohydrate per portion. Preferably, the composition or product may comprise about 15g to about 25g of total carbohydrate per portion.

[0103] The composition or product, e.g., confectionery product, may contain about 0.5-10g, about 0.5-7.5g, about 2.5-7.5g, or about 4-6g of dietary fiber per portion. Preferably, the composition or product may contain about 4g to about 6g of dietary fiber per portion.

[0104] The composition or product, e.g., confectionery product, may contain about 2.5-50g, about 2.5-25g, about 5-25g, about 5-15g, or about 10-15g of total sugar per portion. Preferably, the composition or product may contain about 10g to about 15g of total sugar per portion.

[0105] The composition or product, e.g., confectionery product, may contain about 0.5-20g, about 0.5-10g, about 1-10g, about 1-7.5g, about 2-7.5g or about 2-5g of protein per portion. Preferably, the composition or product may contain about 2g to about 5g of protein per portion.

[0106] The composition or product, e.g., confectionery product, may contain about 10-200 mg, about 10-150 mg, about 10-100 mg, about 25-100 mg, or about 25-75 mg of calcium per portion. Preferably, the composition or product may contain about 25 mg to about 75 mg of calcium per portion.

[0107] The composition or product, e.g., confectionery product, may contain about 50-1000 mg, about 50-750 mg, about 50-500 mg, about 100-500 mg, about 100-300 mg, or about 200-300 mg of potassium per portion. Preferably, the composition or product may contain about 200 mg to about 300 mg of potassium per portion.

[0108] Suitably the composition or product (eg confectionery product) is essentially free of trans fatty acids, cholesterol, sodium and / or vitamin D.

[0109] Preferably, the composition or product (eg, a confectionery product) is essentially free of trans fatty acids, essentially free of cholesterol, essentially free of sodium, and essentially free of vitamin D.

[0110] The present invention also provides a combination package comprising a first product comprising fennel and chamomile, and a second product comprising fennel, ginger, and lemon balm.

[0111] The first product comprising fennel and chamomile may be a confectionery comprising fennel and chamomile as provided in the embodiment described herein.The second product comprising fennel, ginger and lemon balm may be a product comprising fennel, ginger and lemon balm as provided in the embodiment described herein.

[0112] The above composite package may be referred to as a "kit."

[0113] The kit may include 1-20, 1-15, 3-15, 3-10, 3-7, 5-15, 5-10 or 5-7 portions of the first product. The kit may include 3-7 portions of the first product. The kit may include 3, 4, 5, 6 or 7 portions of the first product.

[0114] The kit may include 1-20, 1-15, 3-15, 3-10, 3-7, 5-15, 5-10 or 5-7 portions of the second product. The kit may include 3-7 portions of the second product. The kit may include 3, 4, 5, 6 or 7 portions of the second product.

[0115] The kit may include 3-7 portions of a first product and 3-7 portions of a second product.

[0116] The kit may include 5 portions of a first product and 5 portions of a second product.

[0117] Preferably, each portion is for daily consumption. Preferably, each portion is for daily consumption and provides a daily dose of one or more botanical ingredients as provided by the composition for use according to the present invention.

[0118] Each portion may be packaged individually within the kit. Multiple portions may be packaged together within the kit.

[0119] Manufacturing method The present invention also provides a method for preparing a confectionery product according to the invention, comprising the steps of: a) providing a powder mix comprising: (i) fennel extract powder or dried fennel powder and chamomile extract powder or dried chamomile powder; or (ii) fennel extract powder or dried fennel powder, ginger extract powder or dried ginger powder, and lemon balm extract powder or dried lemon balm powder; b) combining and mixing the powder mix with the dough mix to form a combined dough; and c) forming or shaping the combined dough to form a confectionery mass.

[0120] The powder mix may further comprise cocoa, in particular cocoa powder, and / or one or more fruit flavours.

[0121] The fruit flavour may be selected from raspberry, passion fruit, orange, cranberry, banana or strawberry. The fruit flavour may be a fruit powder.

[0122] The dough mix may include almond butter, date syrup and / or crushed almonds.

[0123] The method may include combining a paste, such as date paste, with the flour mix and dough mix prior to mixing to form a combined dough.

[0124] The date paste may be warmed to about 35° C. before being combined with the powder mix and dough mix.

[0125] Mixing may be carried out in any equipment suitable for mixing doughs.

[0126] Thus, the method of the present invention produces a combination dough comprising a powder mix and a dough mix in a food matrix.

[0127] After mixing, the combined dough may be cooled to below about 25°C.

[0128] The cooled dough can then be subjected to a forming / filling process to produce bite-sized confections. Suitable equipment for such forming / filling includes the CORNUCOPIA® KN135 (Rheon).

[0129] Optionally, additional ingredients (e.g., almond butter) may be added to the combined dough produced by mixing the flour mix with the dough mix. Additional ingredients may be added prior to forming / filling.

[0130] Optionally, a coating, such as a coconut flake coating, may be applied to the morsel.

[0131] Embodiment The present invention provides aspects according to the following numbered paragraphs:

[0132] 1. A composition for use in the treatment and / or prevention of menstrual symptoms, said composition comprising fennel and chamomile. 2. The composition for use according to item 1, wherein the fennel is a fennel extract or dried fennel powder. 3. The composition for use according to item 1 or 2, wherein the composition is administered to a subject to provide a daily dose of 0.05 g to 2.0 g of fennel extract or dried fennel powder, preferably about 0.25 g / day of fennel extract or dried fennel powder. 4. The composition for use according to any one of items 1 to 3, wherein the chamomile is a chamomile extract or a dried chamomile powder. 5. The composition for use according to item 4, wherein the composition is administered to a subject to provide a daily dose of 0.1 g to 5.0 g of chamomile extract or dried chamomile powder, preferably about 0.85 g / day of chamomile extract or dried chamomile powder. 6. The composition for use according to any one of items 1 to 5, wherein the composition further comprises magnesium. 7. The composition for use according to item 6, wherein the composition is administered to a subject to provide a daily dose of 10 to 460 mg of magnesium, preferably about 70 mg / day of magnesium. 8. The composition for use according to any one of items 1 to 7, wherein the menstrual symptoms are premenstrual symptoms selected from one or more of fatigue, mood swings, overeating or cravings, headaches, and / or abdominal cramps. 9. The composition for use according to any one of the preceding claims, wherein the composition is administered before the onset of menstruation, preferably 3 to 7 days before the onset of menstruation. 10. The composition for use according to item 9, wherein the composition is administered for 5 days before the onset of menstruation. 11. The composition for use according to any one of claims 1 to 10, wherein the composition is a confectionery product. 12. The composition for use according to claim 11, wherein the confectionery product has a water activity of less than 0.6. 13. The composition for use according to item 11 or 12, wherein the confectionery product is a bite-sized confectionery product. 14. The composition for use according to any one of claims 11 to 13, wherein the confectionery product comprises cocoa and / or fruit flavors. 15. A composition for use in the treatment and / or prevention of menstrual symptoms, comprising fennel, ginger and lemon balm, wherein said menstrual symptoms are selected from one or more of abdominal cramps, fatigue, mood swings, bloating, and / or back pain. 16. The composition for use according to item 15, wherein the fennel is a fennel extract or dried fennel powder. 17. The composition for use according to item 16, wherein the composition is administered to a subject to provide a daily dose of 0.05 g to 2.0 g of fennel extract or dried fennel powder, preferably about 0.25 g of fennel extract per day. 18. The composition for use according to any one of items 15 to 17, wherein the ginger is a ginger extract or dried ginger powder. 19. The composition for use according to item 14, wherein the composition is administered to a subject to provide a daily dose of 0.1 g to 5.0 g of ginger extract or dried ginger powder, preferably about 0.9 g / day of ginger extract or dried ginger powder. 20. The composition for use according to any one of items 15 to 19, wherein the lemon balm is a lemon balm extract or dried lemon balm powder. 21. The composition for use according to item 20, wherein the composition is administered to a subject to provide a daily dose of 0.1 g to 5.0 g of lemon balm extract or dried lemon balm powder, preferably about 0.9 g / day of lemon balm extract or dried lemon balm powder. 22. The composition for use according to any one of clauses 15 to 21, wherein the composition is administered after the onset of menstruation, preferably for 3 to 7 days after the onset of menstruation. 23. The composition for use according to item 22, wherein the composition is administered for 5 days after the onset of menstruation. 24. The composition for use according to any one of claims 15 to 23, wherein the composition is a confectionery product. 25. A composition for use according to claim 24, wherein the confectionery product has a water activity of less than 0.6. 26. The composition for use according to item 24 or 25, wherein the confectionery product is a bite-sized confectionery product. 27. A composition for use according to any one of claims 24 to 26, wherein the confectionery product comprises cocoa and / or fruit flavours. 28. A composition for use according to any one of items 1 to 14, wherein the composition is administered before the onset of menstruation, followed by administration of a composition for use according to any one of items 15 to 27 after the onset of menstruation. 29. The composition for use according to any one of clauses 15 to 27, wherein the composition is administered after the onset of menstruation and subsequent to administration of the composition for use according to any one of clauses 1 to 14 before the onset of menstruation. 30. A combination of a first composition comprising fennel and chamomile and a second composition comprising fennel, ginger and lemon balm for use in the treatment and / or prevention of menstrual symptoms. 31. The combination for use according to item 30, wherein the first composition is a composition for use according to any one of items 1 to 14, and the premenstrual symptoms are selected from one or more of fatigue, mood swings, overeating or cravings, headache, and / or abdominal cramps. 32. The combination for use according to item 30 or 31, wherein the second composition is a composition for use according to any one of items 15 to 27, and the menstrual symptoms are selected from one or more of abdominal cramps, fatigue, mood swings, bloating, and / or back pain. 33. A method for treating and / or preventing menstrual symptoms comprising administering to a subject a composition comprising fennel and chamomile. 34. The method according to item 33, wherein the composition is a composition according to any one of items 1 to 7 or 11 to 14. 35. The method according to item 33 or 34, wherein the composition is administered according to any one of items 8 to 10. 36. A method for treating and / or preventing menstrual symptoms comprising administering to a subject a composition comprising fennel, ginger, and lemon balm. 37. The method according to item 36, wherein the composition is a composition defined in any one of items 15 to 21 or 24 to 27. 38. The method of claim 36 or 37, wherein the composition is administered according to claim 22 or 23. 39. A method for treating and / or preventing menstrual symptoms comprising administering to a subject a combination of a first composition comprising fennel and chamomile and a second composition comprising fennel, ginger, and lemon balm. 40. The method according to item 39, wherein the first composition is a composition defined in any one of items 1 to 7 or 11 to 14. 41. The method according to item 39 or 40, wherein the first composition is administered according to any one of items 8 to 10. 42. The method according to any one of paragraphs 39 to 41, wherein the second composition is a composition as defined in any one of paragraphs 15 to 21 or 24 to 27. 43. The method according to any one of clauses 39 to 42, wherein the second composition is administered according to clause 22 or 23. 44. A product comprising fennel and chamomile, preferably a confectionery product. 45. The product according to item 44, wherein the fennel is a fennel extract or dried fennel powder. 46. ​​The product according to paragraph 43, comprising 0.05g to 2.0g, 0.05g to 1.0g, or 0.05g to 0.25g of fennel extract or dried fennel powder, preferably about 0.125g of fennel extract or dried fennel powder. 47. The product according to any one of items 47 to 49, wherein the chamomile is a chamomile extract. 48. The product according to item 50, comprising 0.1 g to 5.0 g, 0.1 g to 2.0 g, or 0.25 g to 0.75 g of chamomile extract or dried chamomile powder, preferably about 0.425 g of chamomile extract or dried chamomile powder. 49. The product according to any one of claims 44 to 48, further comprising magnesium. 50. The product according to item 49, containing 10 to 460 mg, 10 to 250 mg, or 15 to 75 mg of magnesium, preferably 35 mg of magnesium. 51. The product according to any one of paragraphs 44 to 50, having a water activity of less than 0.6. 52. The product according to any one of claims 44 to 51, wherein the product is a bite-sized snack. 53. The product according to any one of paragraphs 44 to 52, comprising cocoa and / or fruit flavorings. 54. A product comprising fennel, ginger and lemon balm, preferably a confectionery product. 55. The product according to item 54, wherein the fennel is a fennel extract or dried fennel powder. 56. The product according to paragraph 55, comprising 0.05g to 2.0g, 0.05g to 1.0g or 0.05g to 0.25g of fennel extract, preferably about 0.125g of fennel extract or dried fennel powder. 57. The product according to any one of items 54 to 56, wherein the ginger is a ginger extract or dried ginger powder. 58. The product according to paragraph 57, comprising 0.1 g to 5.0 g, 0.1 g to 2.0 g or 0.25 g to 1.0 g of ginger extract, preferably 0.45 g of ginger extract or dried ginger powder. 59. The product according to any one of items 54 to 58, wherein the lemon balm is lemon balm extract or dried lemon balm powder. 60. The product according to item 59, comprising 0.1 g to 5.0 g, 0.1 g to 2.0 g or 0.25 g to 1.0 g of lemon balm extract or dried lemon balm powder, preferably 0.45 g of lemon balm extract or dried lemon balm powder. 61. The product according to any one of paragraphs 54 to 60, having a water activity of less than 0.6. 62. The product according to any one of claims 54 to 61, wherein the confectionery product is a bite-sized confectionery product. 63. A confectionery product according to any one of claims 54 to 62, wherein the product comprises cocoa and / or fruit flavours. 64. A kit comprising a first product according to any one of items 44 to 53 and a second product according to any one of items 54 to 63. 65. The kit of claim 64, wherein the kit comprises 3 to 7 portions of the first product and 3 to 7 portions of the second product, each portion being for daily consumption. 66. The kit according to item 65, wherein one portion of the first product contains 0.05 g to 2.0 g, 0.05 g to 1.0 g, or 0.05 g to 0.25 g of fennel extract or dried fennel powder, preferably about 0.25 g of fennel extract or dried fennel powder; 0.1 g to 5.0 g, 0.1 g to 2.0 g, or 0.25 g to 0.75 g of chamomile extract or dried chamomile powder, preferably about 0.85 g of chamomile extract or dried chamomile powder; and / or 10 to 460 mg, 10 to 250 mg, or 15 to 75 mg of magnesium, preferably about 70 mg of magnesium. 67. The kit according to item 65 or 66, wherein one portion of the second product contains 0.05g to 2.0g, 0.05g to 1.0g or 0.05g to 0.25g of fennel extract or dried fennel powder, preferably about 0.25g of fennel extract or dried fennel powder; 0.1g to 5.0g, 0.1g to 2.0g or 0.25g to 1.0g of ginger extract or dried ginger powder, preferably about 0.9g of ginger extract or dried ginger powder; and / or 0.1g to 5.0g, 0.1g to 2.0g or 0.25g to 1.0g of lemon balm extract or dried lemon balm powder, preferably about 0.9g of lemon balm extract or dried lemon balm powder. 68. A method for preparing a confectionery product according to any one of claims 44 to 63, comprising: a) providing a powder mix comprising: (i) fennel extract powder or dried fennel powder and chamomile extract powder or dried chamomile powder; or (ii) fennel extract powder or dried fennel powder, ginger extract powder or dried ginger powder, and lemon balm extract powder or dried lemon balm powder; b) combining and mixing the powder mix with a dough mix to form a combined dough; and c) forming or shaping said combined dough to form a confectionery mass. 69. The method of claim 68, wherein the powder mix comprises: (i) fennel extract powder and chamomile extract powder; or (ii) fennel extract powder, ginger extract powder, and lemon balm extract powder. 70. A confectionery product produced according to the method of claim 69.

[0133] The present disclosure is not limited by the exemplary methods and materials disclosed herein, and any methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure.

[0134] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0135] As used herein, the terms "comprising," "comprises," and "comprised of" are synonymous with "including," "includes," or "containing," "contains," and are inclusive or open-ended and do not exclude additional, unspecified members, elements, or method steps. The terms "comprising," "comprises," and "comprised of" also include the term "consisting of."

[0136] Numerical ranges include the numbers that define the range. As used herein, the term "about" means approximately, in the region of, roughly, or in the vicinity of. When the term "about" is used in conjunction with a numerical value or range, the value or range modifies the value or range by expanding the upper and lower boundaries of the stated numerical value(s). In general, the terms "about" and "approximately" are used herein to adjust numerical value(s) above and below the stated value(s) by 10%.

[0137] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Any publications cited herein should not be construed as an admission that they constitute prior art to the claims appended hereto.

[0138] The present invention will now be further described by way of examples, which are meant to be provided to aid those skilled in the art in practicing the invention and are not intended to limit the scope of the invention in any way.

[0139] [Example] Example 1. Botanical extracts for use in treating (pre)menstrual symptoms The ability of the botanical combination to reduce premenstrual symptoms and / or menstrual pain is measured.

[0140] Two compositions are tested. 1) a premenstrual botanical composition (PBC) providing a daily dose of 0.25 g of fennel extract and 0.85 g of chamomile extract; and 2) A menstrual botanical composition (MBC) providing daily doses of 0.25 g fennel extract, 0.9 g ginger extract, and 0.9 g lemon balm extract.

[0141] Premenstrual symptoms will be assessed using the Premenstrual Symptom Scoring Test (PSST). Menstrual pain will be assessed using the Pain Visual Analogue Scale (PVAS). Health-related quality of life will be assessed using the SF36 questionnaire.

[0142] Example 2 Use of a composition containing a plant extract The effect of the composition prepared in Example 1 on premenstrual and menstrual symptoms was measured in 57 women.

[0143] The age range for women was 20 to 54 years old: 15.9% were 20 to 24 years old, 40.9% were 25 to 34 years old, 27.3% were 35 to 44 years old, and 15.9% were 45 to 54 years old.

[0144] Respondents perceived a range of severe symptoms during the premenstrual period. The top five symptoms were fatigue (19%), mood swings (17%), overeating / cravings (16%), headaches (14%), and abdominal cramps (12%). On average, there were 2-3 symptoms per respondent. Symptom severity was high, with a mean severity rating of 7.6 (out of 10).

[0145] Respondents also perceived a range of severe symptoms during their menstrual period. The top five symptoms were abdominal cramps (27%), fatigue (13%), mood swings (12%), bloating (12%), and back pain (10%). On average, there were 2-3 symptoms per respondent. Symptom severity was high, with an average severity rating of 8.2 (out of 10). Symptoms were more severe than premenstrual symptoms.

[0146] In Figures 2 to 7, the graphs on the left show the severity of various symptoms during the premenstrual period before and after ingestion of a bite of candy. For each user ID, the severity of symptoms before ingestion (bars on the left) and after ingestion (bars on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was performed after one cycle of ingestion of a bite of candy (graphs on the right).

[0147] During the premenstrual period, the following symptoms were most improved (in order): fatigue (Figure 2), mood swings (Figure 3), overeating / cravings (Figure 4), headaches (Figure 5), abdominal cramps (Figure 6), and bloating (Figure 7). Fatigue was the most improved symptom, and bloating was the sixth most improved symptom.

[0148] In Figures 8 to 13, the graphs on the left show the severity of various symptoms during menstruation before and after ingesting a bite-sized snack. For each user ID, the severity of symptoms before ingestion (bars on the left) and after ingestion (bars on the right) were rated on a scale of 1 to 10. Evaluation of various symptoms was conducted after ingesting one cycle of a bite-sized snack (graph on the right).

[0149] During menstrual periods, the following symptoms improved the most (in order): abdominal cramps (Figure 8), fatigue (Figure 9), mood swings (Figure 10), bloating (Figure 11), back pain (Figure 12), and overeating / cravings (Figure 13). Abdominal cramps improved the most, and overeating / cravings was the sixth most improved symptom.

[0150] Example 3: Production of a bite-sized snack containing a plant extract The botanical ingredient containing snack bites are produced according to the schematic diagram shown in FIG.

[0151] Two types of bite-sized snacks are produced. 1) A premenstrual snack containing fennel extract and chamomile extract. 2) Menstrual snacks containing fennel extract, ginger extract and lemon balm extract.

[0152] All publications mentioned in the above specification are incorporated herein by reference. Various modifications and variations of the methods and systems described in this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed is not to be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art of molecular biology or related fields are intended to be within the scope of the following claims.

Claims

1. 1. A composition for use in the treatment and / or prevention of menstrual symptoms, the composition comprising fennel and chamomile.

2. (i) the fennel is fennel extract or dried fennel powder, and the composition is administered to a subject to provide a daily dose of 0.05 g to 2.0 g of fennel extract or dried fennel powder; (ii) the chamomile is chamomile extract or dried chamomile powder, and the composition is administered to a subject to provide a daily dose of 0.1 g to 5.0 g of chamomile extract or dried chamomile powder; The composition of claim 1.

3. The composition of claim 1 , wherein the menstrual symptoms are premenstrual symptoms.

4. The composition described in claim 3, wherein the composition is administered before the onset of menstruation.

5. The composition described in claim 3, wherein the composition is administered for 3 to 7 days before the onset of menstruation.

6. 1. A composition for use in the treatment and / or prevention of menstrual symptoms, the composition comprising fennel, ginger and lemon balm.

7. (i) the fennel is fennel extract or dried fennel powder, and the composition is administered to a subject to provide a daily dose of 0.05 g to 2.0 g of fennel extract or dried fennel powder; (ii) the ginger is ginger extract or dried ginger powder, and the composition is administered to a subject to provide a daily dose of 0.1 g to 5.0 g of ginger extract or dried ginger powder; (iii) the lemon balm is lemon balm extract or dried lemon balm powder, and the composition is administered to a subject to provide a daily dose of 0.1 g to 5.0 g of lemon balm extract or dried lemon balm powder. The composition of claim 6.

8. The composition of claim 6 , wherein the composition is administered after the onset of menstruation.

9. The composition described in claim 8, wherein the composition is administered for 3 to 7 days after the onset of menstruation.

10. The composition according to any one of claims 1 to 9, wherein the composition is a confectionery product.

11. 1. A combination of a first composition comprising fennel and chamomile and a second composition comprising fennel, ginger, and lemon balm for use in the treatment and / or prevention of menstrual symptoms.

12. the first composition is a composition for use in the treatment and / or prevention of menstrual symptoms according to any one of claims 1 to 5, the menstrual symptoms being fatigue; and / or 12. The combination according to claim 11, wherein the second composition is a composition for use in the treatment and / or prevention of menstrual symptoms according to any one of claims 6 to 9, wherein the menstrual symptoms are abdominal cramps.

13. The combination of claim 12 , wherein the first composition and / or the second composition is a confectionery product.

14. A product comprising fennel and chamomile, (i) the fennel is a fennel extract or dried fennel powder, and the product comprises 0.05 g to 2.0 g of the fennel extract or dried fennel powder; and / or (ii) The chamomile is a chamomile extract or dried chamomile powder, and the product comprises 0.1 g to 5.0 g of the chamomile extract or dried chamomile powder.

15. 1. A product comprising fennel, ginger, and lemon balm, (i) the fennel is a fennel extract or a dried fennel powder; and the product contains 0.05 g to 2.0 g of the fennel extract or the dried fennel powder; (ii) the ginger is ginger extract or dried ginger powder, and the product contains 0.1 g to 5.0 g of ginger extract or dried ginger powder; and (iii) The lemon balm is lemon balm extract or dried lemon balm powder; and the product contains 0.1 g to 5.0 g of lemon balm extract or dried lemon balm powder.

16. A product as described in claim 14 or 15, wherein the product is a confectionery product.

17. A kit comprising a first product of claim 14 and a second product of claim 15.

18. one portion of said first product comprises 0.05 g to 2.0 g of fennel extract or dried fennel powder; 0.1 g to 5.0 g of chamomile extract or dried chamomile powder; and / or 10 to 460 mg of magnesium; and / or 18. The kit of claim 17, wherein one portion of the second product comprises 0.05g to 2.0g of fennel extract or dried fennel powder; 0.1g to 5.0g of ginger extract or dried ginger powder; and / or 0.1g to 5.0g of lemon balm extract or dried lemon balm powder.

19. a) (i) fennel extract powder or dried fennel powder and chamomile extract powder or dried chamomile powder; or (ii) fennel extract powder or dried fennel powder, ginger extract powder or dried ginger powder, and lemon balm extract powder or dried lemon balm powder; providing a powder mix comprising: b) combining and mixing the powder mix with a dough mix to form a combined dough; and c) forming or shaping the combined dough to form a confectionery mass; 17. A method for preparing the product of claim 16, comprising:

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