Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/88—Liliopsida (monocotyledons)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P25/00—Drugs for disorders of the nervous system

Definitions

• the present invention relates to a particular saffron extract for use in the treatment of sleep disorders in humans.
• insomnia sleep disorders, especially insomnia, are common pathologies that affect more and more people. In France, for example, about 30% of adults have frequent insomnia and 15% complain of chronic insomnia, with a higher prevalence among women.
• Sleep disorders can have many origins, such as stress. Stressful life events often lead to ruminating at bedtime, which has been correlated with the perception of poor sleep, and depression and anxiety are seen as major causes of insomnia. .
• Certain medications, or the consumption of alcohol or caffeinated beverages also have a negative impact on sleepiness and quality of sleep.
• Creativity and innovation are also modes of reasoning particularly degraded by a debt of sleep.
• the bad sleep also plays on the mood: irritability, anger, hostility.
• people who are lacking sleep feel less friendly, empathic and lose their ability to reap the emotional benefits of a positive experience.
• Chronic insomnia is also considered a risk factor for anxiety and depressive disorders.
• chronic sleep deprivation induces chronic inflammation along with immunodeficiency with increased susceptibility to infection and reduced immune response to vaccination.
• GABA gamma-aminobutyric acid
• a product of natural origin namely: a saffron extract with an efficiency on both the quality of sleep and the time of falling asleep.
• the saffron extract comprising crocins and crocetins is suitable for use in the treatment of sleep disorders.
• This extract helps to fight against all sleep disorders, including transient or chronic dyssomnias, transient or chronic parasomnias. It is particularly effective in the treatment of sleep disorders related to stress, anxiety, worries, jet lag or psychiatric or neurological origin.
• administration of crocin or crocetin is by the oral route using a unit dose.
• the present invention which is based on this original observation, is primarily intended to provide a saffron extract comprising crocins and crocetins, for use in the treatment of sleep disorders in humans, aimed at least to reduce a previously mentioned limitation.
• said saffron extract comprises at least 2% of crocines by weight relative to the total weight of dry matter of the extract.
• said saffron extract according to the invention can be used in the treatment of transient or chronic dyssomnias.
• said saffron extract according to the invention can be used in the treatment of transient or chronic parasomnias.
• said saffron extract according to the invention can be used in the treatment of sleep disorders related to stress, anxiety, preoccupation, jet lag or of psychiatric, neurological or other diseases.
• the saffron extract according to the invention comprises at least one compound chosen from picrocrocine, flavonoids, fibers and proteins.
• the saffron extract according to the invention has a crocetin / crocin ratio of less than 1/10.
• the saffron extract according to the invention is present as an extract of stigmas of category 1 saffron.
• the saffron extract according to the invention is obtained by hydroalcoholic extraction.
• the saffron extract according to the invention is obtained by a process comprising the implementation of the following steps: • multiple hydroalcoholic extraction,
• said saffron extract may be used in a composition.
• said saffron extract according to the invention can be used in aqueous form or in dry form, the composition comprising a suitable food carrier.
• this food carrier is chosen from: gum arabic, silica, maltodextrin, titanium dioxide, starch, lactose, glucose microcrystalline cellulose, salt or a mixture.
• said saffron extract according to the invention represents at least 0.1% by weight relative to the total weight of the composition.
• said saffron extract according to the invention may also represent at least 1% by weight relative to the total weight of the composition.
• said composition is in liquid, pasty or solid form.
• FIG. 1 represents graphical representations of the results of a double-blind placebo-controlled clinical study carried out with the extract according to the invention, for the quality of the sleep, the time of falling asleep and the restful sleep,
• Figure 2 represents graphical representations of the results of a self-evaluation questionnaire of a double-blind clinical study against placebo performed with the extract according to the invention, for the quality of sleep, relaxation and memory.
• the invention therefore relates to an extract of Saffron comprising crocins and crocetins, for use in the treatment of sleep disorders in humans.
• Crocetin is a carotenoid diacid carboxylic acid that exists in free form (crocetin) or as a glycoside ester (crocin). This family of molecules is responsible for the garnet color of saffron and especially many biological properties such as beneficial actions on o lipid metabolism, atherosclerosis, insulin resistance, reduction of oxidative stress, reduction the lack effect (addiction).
• Saffron extract any part of the plant or any molecule or mixture of molecules extracted from all or part of the plant.
• the extract is derived from whole or reduced Saffron stigmas in powder form, more preferably Stigma stigmas of category 1 with the highest crocin and crocetins content.
• the stigmas are preferably dried stigmas in order to protect them from mold and other bacteriological contamination which would affect the edibility of the product as well as its crocin / crocetins content.
• the Saffron extract comprises at least 2% of crocines by weight relative to the total weight of solids, in particular between 2 and 50%, more preferably between 10 and 15%.
• this concentration makes it possible to obtain the daily dose with a quantity of extract that is adequate to be formulated in a capsule of dietary supplement.
• the extract has a crocetin / crocin ratio of less than 1/5 and even more preferably less than 1/10. Such a ratio makes it possible to ensure that the crocins are stable in the extract and that they have not undergone hydrolysis during extraction.
• the Safran extract may also comprise other constituents.
• the Safran extract also comprises at least one compound selected from picrocrocine, flavonoids, fibers, proteins. It may also contain other organic molecules. These constituents together improve the effect of the extract because there is a synergy between these different constituents. The use of the totum is therefore preferred.
• E 1% 5 for the wavelength of 440 nm and preferably E 1% 3oonm> 13.
• the saffron extract according to the invention can be obtained by any suitable method.
• it is obtained by hydroalcoholic extraction, in particular by a process comprising the implementation of the following steps:
• hydroalcoholic extraction with a solvent preferably containing 20 to 80% alcohol (by volume); the extraction lasts preferably 30min to 4h and may be repeated 1 to 5 times;
• the filter is preferably made of a compatible material for food contact.
• the evaporation under vacuum is preferably carried out at a moderate temperature (30 to 50 ° C) under reduced pressure (100 to 300 mbar).
• drying on a suitable foodstuff can be carried out by atomization, lyophilization, steaming or fluidized bed.
• the Safran extract according to the invention may be in aqueous (liquid) or dry (solid) form. It can be used alone or in a composition.
• composition within the meaning of the invention is meant a mixture of Safran extract according to the invention with at least one other constituent.
• the composition may especially be a composition comprising a suitable food carrier.
• suitable food carrier is preferably chosen from: gum arabic, silica, maltodextrin, titanium dioxide, starch, lactose, microcrystalline cellulose, glucose, salt or a mixture of at least two of these elements .
• composition may contain other elements such as:
• composition comprising the extract of Safran according to the invention may be in liquid form (for example syrup, emulsion, oral solution), pasty (for example cream or gel) or solid (for example powder, cachet, tablet, dragee or capsule).
• the saffron extract according to the invention represents at least 0.1% by weight relative to the total weight of the composition, still more preferably at least 1% by weight relative to the total weight of the composition.
• the Safran extract according to the invention can be used alone or with other active ingredients such as, for example, pharmaceutical active ingredients, rhodiola extracts, vitamin B6 or magnesium. These active ingredients can be introduced into a composition containing Safran extract or administered separately.
• the Safran extract according to the invention is useful in the treatment of sleep disorders in humans, in particular: • in the treatment of transient or chronic dyssomnias
• the use of the extract of saffron according to the invention makes it possible to reduce the time necessary for falling asleep, reduces nocturnal awakenings 5 and thus leads to an awakening in shape
• the Safran extract according to the invention is particularly useful in the treatment of sleep disorders related to stress, anxiety, anxiety, jet lag, psychiatric, neurological or other diseases.
• the extract according to the invention is preferably used in a composition for daily administration of 0.5 mg to 100 mg of Saffron extract.
• the invention is now illustrated by non-limiting examples of active principle and composition according to the invention as well as by the results of a randomized double-blind placebo-controlled clinical trial.
• Safran extract on a liquid base particularly adapted according to the invention is an extract obtained by a process implementing the following steps:
• the liquid phase is recovered by filtration and then the volume of the filtrate is reduced by evaporation under vacuum (50 ° C., 200 mbar).
• the resulting extract is composed of 5.8 kg of dry matter, including 606 g of crocin as determined by spectrophotometric analysis according to ISO 3632.
• Example 2 Saffron Extract on a Liquid Base
• the liquid phase is recovered by filtration and then the volume of the filtrate is reduced by evaporation under vacuum (50 ° C., 200 mbar).
• the resulting extract is composed of 9 kg of dry matter including 968 g of crocin as determined by HPLC analysis.
• Safran extract on a solid base particularly adapted according to the invention is an extract obtained by a method implementing the following steps:
• the liquid phase is recovered by filtration and then the volume of the filtrate is reduced by evaporation under vacuum (50 ° C., 200 mbar).
• the extract is then spray-dried in the presence of maltodextrins acting as a carrier for easy manipulation and dosage of the plant extract.
• the extract produced contains 2.5% crocins, with a relative humidity of 2.7%.
• the liquid phase is recovered by filtration and then the volume of the filtrate is reduced by evaporation under vacuum (50 ° C., 200mbar).
• the extract is then dried by lyophilization in the presence of maltodextrins.
• the extract produced contains 10.65% Crocin as determined by HPLC analysis.
• Example 5 Composition Comprising Saffron Extract in Liquid Form
• composition for a "shot" type drink comprising a Safran extract particularly adapted according to the invention is a composition in liquid form comprising the following constituents:
• Example 6 Composition Comprising a Saffron Extract in Capsule Form
• Vitamin B12 2.5 pg
• Example 7 Composition Comprising an Saffron Extract in the Form of a Tablet
• composition in tablet form comprising a Safran extract particularly adapted according to the invention is a composition in the form of capsules comprising the following constituents:
• Example 7 A randomized, double-blind, placebo-controlled clinical trial was conducted. Subjects took the extract from Example 3, in the composition (tablet of Example 7) or placebo once a day for 6 weeks.
• the volunteers (15 for the placebo, 15 for the extract according to the invention) included in the study are subjects under moderate stress for more than one month.
• Efficacy was assessed using two types of questionnaires: • An assessment questionnaire that includes 25 questions on aspects of cognition, depression, anxiety, somatization, eating behaviors and sleep. These questions are noted and the average scores of the score were compared by t-test, a self-assessment questionnaire that includes 9 questions whose answer consists in placing a cursor on a line of ten centimeters. The cursor position is measured and the average positions are compared using a t-test.
• the assessment group increased for all participants in the group treated according to the invention.
• the saffron extracts according to the invention thus show a remarkable effect on sleep.
• the extract according to the invention is well tolerated and shows no adverse effect. In contrast, compared to placebo, the extract according to the invention tends to improve cognitive functions.
• the subjects of the group treated with the extract according to the invention were satisfied with the product for 73% of them against 6% for the placebo.

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• 2016
  • 2016-03-09 FR FR1670093A patent/FR3048615B1/fr active Active
• 2017
  • 2017-02-16 EP EP17709170.9A patent/EP3426277A1/de not_active Withdrawn
  • 2017-02-16 WO PCT/IB2017/000121 patent/WO2017153829A1/fr active Application Filing

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