EP3700358A1 - Energizing food supplement and use thereof - Google Patents

Energizing food supplement and use thereof

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Publication number
EP3700358A1
EP3700358A1 EP18800050.9A EP18800050A EP3700358A1 EP 3700358 A1 EP3700358 A1 EP 3700358A1 EP 18800050 A EP18800050 A EP 18800050A EP 3700358 A1 EP3700358 A1 EP 3700358A1
Authority
EP
European Patent Office
Prior art keywords
food supplement
extract
vitamin
supplement according
taurine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP18800050.9A
Other languages
German (de)
French (fr)
Inventor
Glauco ISELLA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP3700358A1 publication Critical patent/EP3700358A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/175—Amino acids
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A61K31/51—Thiamines, e.g. vitamin B1
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135—Compounds containing heavy metals
    • A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention relates to an energizing food supplement, particularly for the prevention and treatment of the effects of a hangover.
  • the present invention also relates to the use of this energizing supplement for the prevention and treatment of the effects of a hangover such as, for example, tiredness, headache, nausea, difficulty concentrating, sensitivity to light and noise, and insomnia.
  • a hangover such as, for example, tiredness, headache, nausea, difficulty concentrating, sensitivity to light and noise, and insomnia.
  • Alcohol An excessive intake of alcohol (ethanol) produces the symptoms of alcohol intoxication such as initial euphoria, loss of inhibitions, slurred or confused speech (typically associated with a blood alcohol level of 0.2-0.4 g/L), vomiting, loss of balance (0.5-1.5 g/L), and even coma in more serious cases (higher than 4.0-5.0 g/L).
  • Intoxication is the result of the introduction of an amount of alcohol that is greater than the amount that can be metabolized and excreted by the organism.
  • the after-effects that are present upon awakening after intoxication from alcoholic beverages are referred to as a "hangover" and they include: dehydration, headache, hypoglycemia, exhaustion, and feelings of nausea.
  • one of the symptoms of a hangover, dehydration is caused by inhibition of the vasopressin hormone by acetaldehyde in the brain, which impedes the concentration of urine and therefore causes a considerable diuretic effect.
  • the hypoglycemia is caused by a slowing of gluconeogenesis in the liver, owing to the excess of NADH produced during the metabolization of the ethanol and the subsequent conversion of pyruvic acid to lactic acid which accumulates in the tissues, another factor that results from the breakdown of ethanol.
  • the ethanol is in fact converted to acetaldehyde by the alcohol dehydrogenase enzyme and the acetaldehyde in turn is converted to acetate by the acetaldehyde dehydrogenase enzyme.
  • Acetaldehyde and acetate are highly toxic; in particular acetaldehyde is about 30 times more toxic than alcohol per se; therefore it is the main cause of the effects of a hangover.
  • VLDLs very-low-density lipoproteins
  • the aim of the present invention is therefore to provide a food supplement that helps to alleviate the effects of a hangover, thus helping the sufferer to faster return to a normal level of psycho- physical functionality.
  • Another object of the present invention is to provide a food supplement that has a protective function on the liver.
  • Another object of the present invention is to provide a food supplement that favors physical and mental wellness and positively influences the cognitive processes.
  • Another object of the present invention is to provide a food supplement that is easy to take and which has the desired effects within a short time.
  • an energizing food supplement particularly for preventing or treating the effects of a hangover, which comprises:
  • the aims and the objects of the present invention are also achieved by the above mentioned energizing food supplement for use in the prevention and treatment of the effects of the effects of a hangover.
  • the present invention relates to an energizing food supplement, particularly for preventing or treating the effects of a hangover, as defined above and characterized in that it comprises an association of active ingredients constituted by creatine, taurine, caffeine, ashwagandha (withania somnifera) extract, milk thistle (silybum marianum) extract, willow (salix alba) extract, vitamin B12, vitamin B6, vitamin Bl , and fructose.
  • active ingredients constituted by creatine, taurine, caffeine, ashwagandha (withania somnifera) extract, milk thistle (silybum marianum) extract, willow (salix alba) extract, vitamin B12, vitamin B6, vitamin Bl , and fructose.
  • Creatine which is converted to phosphocreatine in the body, facilitates the use of oxygen and the formation of ATP and therefore of energy used in intense efforts by muscles. It therefore contributes to counteract exhaustion.
  • the food supplement of the present invention comprises creatine in a quantity of 0.2 mg/mL to 40 mg/mL.
  • the food supplement of the present invention comprises 10 mg/mL of creatine.
  • the creatine is in monohydrate form.
  • Taurine is one of the osmolytes that regulate cellular volume. Therefore, the ingestion of taurine by dehydrated subjects after the ingestion of alcohol stimulates the introduction of water into the cells. Taurine also has an important physiological role, as it is a necessary component in the synthesis of bile acids, it improves the use of sugars and it increases the effectiveness of insulin, thus facilitating a rapid use of the fructose present in the supplement.
  • Taurine performs several actions on the body: it improves the metabolism of lipids and of sugars at the hepatic level; it facilitates the renal excretion of toxic substances; it facilitates the contractility of the skeletal muscle and of the heart, increasing its cardiac output. It is therefore recommended for increasing physiological performance and reducing recovery times.
  • taurine is in fact an amino acid that calms the nervous system, because it supports the production of gamma-aminobutyric acid (GABA). It can facilitate the management of anxiety, potentially counteracting stress hormones. Its use as an ingredient in the formulation of the supplement facilitates temperature control and improves concentration.
  • the food supplement of the present invention comprises taurine in a quantity of 0.2 mg/mL to 40 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 10 mg/mL of taurine.
  • Caffeine has many effects on the human body and is capable of reducing the sense of tiredness, increasing alertness and stimulating intestinal motility, promoting a general state of wellbeing, both physiological and neurological.
  • Caffeine has a stimulating action on the central nervous system (CNS), on the cardiovascular apparatus, on the release of catecholamines, on the synthesis of gastric acid and on the metabolism in general. Furthermore, caffeine produces an increase in the state of wakefulness and of alertness, of the capacity for concentration, and general enhancement of physical and mental efficiency. As well as the excitatory activity, which is very good for counteracting the exhaustion typical of a hangover, caffeine also has a vasoconstricting action, which produces a slight analgesic effect, and can therefore be exploited to act against the headache caused by vasodilatation in the brain.
  • the food supplement of the present invention comprises caffeine in a quantity of 0.2 mg/mL to 40 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 8 mg/mL of caffeine.
  • the food supplement of the present invention also comprises ashwagandha (withania somnifera) root extract in its active ingredients.
  • Ashwagandha has neuro-protective properties and an adaptogenic and anxiolytic activity that can help the subject to overcome the phenomena of anxiety and depression that are typical of the effects of a hangover, owing to the action of alcohol and acetaldehyde on the central nervous system.
  • Most of the properties ascribed to ashwagandha are in particular due to the withanolides (steroidal lactones) contained in it.
  • Ashwagandha also has an anticonvulsant activity, which is probably related to an interaction with the receptor of the barbiturates present in the receptor for GABA.
  • Ashwagandha also improves mood tone, thus reducing the irritability and impatience that are typical of the effects of a hangover.
  • the food supplement of the present invention comprises ashwagandha extract in a quantity of 0.04 mg/mL to 20 mg/mL, preferably with a content of 0.002 mg/mL to 1.2 mg/mL of withanolides.
  • the food supplement of the present invention comprises 1.6 mg/mL of ashwagandha extract, preferably with a content of 0.08 mg/mL of withanolides.
  • the ashwagandha extract can for example be the KSM-66® product marketed by Ixoreal Biomed.
  • Milk thistle (silybum marianum) fruit extract has effects on the digestive function and on the hepatic function, and it carries out a purifying and antioxidant function.
  • silymarin a complex of bioflavonoids called flavonolignans contained in milk thistle extract, carries out a defense function against many toxic substances, including alcohol.
  • Milk thistle extract is also an antioxidant that prevents the oxidation of lipids and the destruction of cellular membranes.
  • milk thistle extract The hepatoprotective effect of milk thistle extract is given by the acceleration of the liver regeneration process. Furthermore, milk thistle extract increases the metabolic activity of the hepatic cells. Therefore it facilitates the excretory system and detoxification in general. In effect, the silymarin contained in it stimulates protein synthesis and regeneration of the hepatic parenchyma.
  • the food supplement of the present invention comprises milk thistle extract in a quantity of 0.04 mg/mL to 20 mg/mL, preferably with a content of 0.032 mg/mL to 16 mg/mL of silymarin.
  • the food supplement of the present invention comprises 0.2 mg/mL of milk thistle extract, preferably with a content of 0.16 mg/mL of silymarin.
  • Willow (salix alba) extract by virtue of its anti-inflammatory activity, counteracts the headache owing to the generalized inflammation in the brain caused by alcohol intoxication and localized vasodilatation.
  • Willow extract is rich in tannins, flavonoids, glycosides and esters which, by hydrolysis, produce salicylic acid, in particular from a phenolic glycoside called salicin.
  • the anti-inflammatory activity of willow is given not just by salicin, but also by other phenolic glycosides that act as prodrugs of salicylic acid.
  • Salicylic acid further inhibits the formation of inflammatory mediators.
  • salicin does not irreversibly inhibit platelet aggregation.
  • the food supplement of the present invention comprises willow extract in a quantity of 0.04 mg/mL to 20 mg/mL, preferably with a content of 0.006 mg/mL to 3 mg/mL of salicin.
  • the food supplement of the present invention comprises 0.4 mg/mL of willow extract, preferably with a content of 0.06 mg/mL of salicin.
  • vitamin B12 contributes to energy metabolism and to the reduction of tiredness and fatigue, to the operation of the nervous system, to normal psychological functioning, to the metabolism of homocysteine and to the formation of red blood cells, it intervenes in the process of cell division, and it contributes to the functioning of the immune system.
  • Vitamin B6 has an antiemetic action, it counteracts feelings of nausea, and it restores hormonal activity altered by the effects of alcohol.
  • Vitamin B6 further contributes to the normal synthesis of cysteine, to achieving normal energy metabolism, to the operation of the nervous system, to the metabolism of homocysteine, to the metabolism of proteins and of glycogen, and to psychological functioning. Vitamin B6 also contributes to the formation of red blood cells, to the functioning of the immune system, and to reducing tiredness and fatigue.
  • vitamin B6 contributes to the regulation of hormonal activity.
  • Vitamin Bl (thiamine) contributes to energy metabolism, to cardiac function, to the operation of the nervous system and to psychological functioning.
  • the dosage of the vitamins in the supplement of the present invention is particularly significant with respect to the Nutrient Reference Value (NRV).
  • NSV Nutrient Reference Value
  • Their action is very rapid as they are water-soluble vitamins, and the doses used in the present invention are safe as well as effective since, although high, such doses are lower than the maximum recommended daily intake and any excess can be easily eliminated by the body.
  • the food supplement of the present invention comprises vitamin B12 in a quantity of 0.04 ⁇ g/mL to 8 ⁇ g/mL. In a preferred embodiment, the food supplement of the present invention comprises 0.6 ⁇ g/mL of vitamin B12.
  • the food supplement of the present invention comprises vitamin B6 in a quantity of 0.04 mg/mL to 6 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 168 ⁇ g/mL of vitamin B6.
  • the food supplement of the present invention comprises vitamin Bl in a quantity of 0.04 mg/mL to 4 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 99 ⁇ g/mL of vitamin Bl .
  • the fructose contained in the formulation of the supplement according to the invention is rapidly absorbed and converted to glucose, in this manner counteracting the hypoglycemia.
  • the food supplement of the present invention comprises fructose in a quantity of 10 mg/mL to 400 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 200 mg/mL of fructose.
  • the food supplement according to the invention can furthermore contain one or more excipients.
  • excipients can be selected from the group consisting of flavorings (for example pear flavoring), thickeners (for example xanthan gum, preferably in an amount of about 1-100 mg/mL i.e. 0.1-10% w/v, more preferably 5 mg/mL i.e. 0.5% w/v), acidifiers (for example citric acid), preservatives (for example potassium sorbate and/or sodium benzoate) and sweeteners (for example sucralose and/or steviol glycosides).
  • flavorings for example pear flavoring
  • thickeners for example xanthan gum, preferably in an amount of about 1-100 mg/mL i.e. 0.1-10% w/v, more preferably 5 mg/mL i.e. 0.5% w/v
  • acidifiers for example citric acid
  • preservatives for example potassium sorbate and/or sodium benzoate
  • the active ingredients and any excipients of the supplement according to the present invention are contained in a physiologically acceptable carrier, preferably water, for example osmotic water.
  • the energizing food supplement according to the invention comprises, more preferably is essentially constituted by, and even more preferably is constituted by:
  • excipients consisting of a combination of an aroma, xanthan gum, potassium sorbate, sodium benzoate, sucralose and steviol glycosides,
  • a physiologically acceptable vehicle constituted by osmotic water.
  • the energizing food supplement according to the invention can be formulated in a ready-to-use solution.
  • the food supplement according to the invention can be supplied in phials, or other container suitable for use, preferably in a 25 mL dose.
  • Another aspect of the present invention relates to the energizing food supplement according to the invention for use in the prevention and treatment of the effects of a hangover.
  • the effects of a hangover comprise tiredness, headache, nausea, difficulty concentrating, sensitivity to light and noise, and insomnia.
  • the energizing food supplement is taken preferably upon awakening, preferably with a 25 mL dose.
  • the present invention also relates to a method for preventing and treating the effects of a hangover by way of the administration to a subject who needs it of an energizing food supplement as described herein.
  • the energizing food supplement according to the invention is effective in alleviating the effects of a hangover, such as in particular tiredness, headache and ability to concentrate, by virtue of the combined action of its active ingredients.
  • the food supplement according to the invention counteracts headache by virtue of the vasoconstricting action induced by the caffeine, helps rapidly to reactivate the metabolism by virtue of the high doses of vitamins B6, B 12 and Bl, counteracts dehydration by virtue of the taurine, reduces pain and headache by virtue of the action of the willow, and helps to counteract anxiety and stress by contributing to a rapid restoration of mental and physical wellness by virtue of the ashwagandha.
  • the food supplement according to the invention has a hepatoprotective action, by virtue of the taurine which contributes to the liver function, and the silymarin, which counteracts the damage caused by alcohol.
  • the taurine and the milk thistle eliminate the free radicals due to intoxication and have a protective action on the liver, facilitating its activity.

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Abstract

An energizing food supplement that comprises creatine, taurine, caffeine, ashwagandha (withania somnifera) extract, milk thistle (silybum marianum) extract, willow (salix alba) extract, vitamin B12, vitamin B6, vitamin B1, fructose and optionally one or more excipients, in a physiologically acceptable carrier. The invention further relates to such supplement for use in the prevention and treatment of the effects of a hangover.

Description

ENERGIZING FOOD SUPPLEMENT AND USE THEREOF
The present invention relates to an energizing food supplement, particularly for the prevention and treatment of the effects of a hangover.
The present invention also relates to the use of this energizing supplement for the prevention and treatment of the effects of a hangover such as, for example, tiredness, headache, nausea, difficulty concentrating, sensitivity to light and noise, and insomnia.
An excessive intake of alcohol (ethanol) produces the symptoms of alcohol intoxication such as initial euphoria, loss of inhibitions, slurred or confused speech (typically associated with a blood alcohol level of 0.2-0.4 g/L), vomiting, loss of balance (0.5-1.5 g/L), and even coma in more serious cases (higher than 4.0-5.0 g/L).
Intoxication is the result of the introduction of an amount of alcohol that is greater than the amount that can be metabolized and excreted by the organism. The after-effects that are present upon awakening after intoxication from alcoholic beverages are referred to as a "hangover" and they include: dehydration, headache, hypoglycemia, exhaustion, and feelings of nausea.
In particular, one of the symptoms of a hangover, dehydration, is caused by inhibition of the vasopressin hormone by acetaldehyde in the brain, which impedes the concentration of urine and therefore causes a considerable diuretic effect.
The hypoglycemia is caused by a slowing of gluconeogenesis in the liver, owing to the excess of NADH produced during the metabolization of the ethanol and the subsequent conversion of pyruvic acid to lactic acid which accumulates in the tissues, another factor that results from the breakdown of ethanol. The ethanol is in fact converted to acetaldehyde by the alcohol dehydrogenase enzyme and the acetaldehyde in turn is converted to acetate by the acetaldehyde dehydrogenase enzyme. Acetaldehyde and acetate are highly toxic; in particular acetaldehyde is about 30 times more toxic than alcohol per se; therefore it is the main cause of the effects of a hangover.
The aforementioned two reactions also require the conversion of NAD+ to NADH. With the exceeding NADH, the reaction of the lactate dehydrogenase enzyme leads to the production of lactate from pyruvate (the final product of glycolysis) in order to regenerate the necessary NAD+. This deviates the pyruvate from other routes, such as gluconeogenesis, thus interfering with the ability of the liver to resupply tissues with glucose, especially the brain. Since glucose is the main energy source of the brain, this lack of glucose contributes to symptoms such as fatigue, weakness, mood swings and decrease in attention and in concentration.
The feeling of exhaustion is the result of the accumulation of triglycerides and of the formation of ketone bodies resulting from the elimination of acetic acid. This is reflected in the increase in the hepatic synthesis of very-low-density lipoproteins (VLDLs) and causes them to be deposited in the liver (hepatic steatosis), and also the increase in their plasma concentration.
Furthermore, the generalized effect of intoxication by acetaldehyde in the central nervous system and in the brain causes vasodilatation and can induce nausea and vomiting.
Faced with the more or less debilitating consequences owing to the consumption of alcohol, the aim of the present invention is therefore to provide a food supplement that helps to alleviate the effects of a hangover, thus helping the sufferer to faster return to a normal level of psycho- physical functionality.
Another object of the present invention is to provide a food supplement that has a protective function on the liver.
Another object of the present invention is to provide a food supplement that favors physical and mental wellness and positively influences the cognitive processes. Another object of the present invention is to provide a food supplement that is easy to take and which has the desired effects within a short time.
This aim and these and other objects which will become better apparent hereinafter are achieved by an energizing food supplement, particularly for preventing or treating the effects of a hangover, which comprises:
- 0.2 mg/mL to 40 mg/mL of creatine,
- 0.2 mg/mL to 40 mg/mL of taurine,
- 0.2 mg/mL to 40 mg/mL of caffeine,
- 0.04 mg/mL to 20 mg/mL of ashwagandha (Withania somnifera) extract,
- 0.04 mg/mL to 20 mg/mL of milk thistle (Silybum marianum) extract,
- 0.04 mg/mL to 20 mg/mL of willow (Salix alba) extract,
- 0.04 μg/mL to 8 μg/mL of vitamin B12,
- 0.04 mg/mL to 6 mg/mL of vitamin B6,
- 0.04 mg/mL to 4 mg/mL of vitamin B l,
- 10 mg/mL to 400 mg/mL of fructose, and
optionally one or more excipients, in a physiologically acceptable carrier.
The aims and the objects of the present invention are also achieved by the above mentioned energizing food supplement for use in the prevention and treatment of the effects of the effects of a hangover.
Further characteristics and advantages of the invention will become better apparent from the detailed description that follows.
The present invention relates to an energizing food supplement, particularly for preventing or treating the effects of a hangover, as defined above and characterized in that it comprises an association of active ingredients constituted by creatine, taurine, caffeine, ashwagandha (withania somnifera) extract, milk thistle (silybum marianum) extract, willow (salix alba) extract, vitamin B12, vitamin B6, vitamin Bl , and fructose.
Creatine, which is converted to phosphocreatine in the body, facilitates the use of oxygen and the formation of ATP and therefore of energy used in intense efforts by muscles. It therefore contributes to counteract exhaustion.
The food supplement of the present invention comprises creatine in a quantity of 0.2 mg/mL to 40 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 10 mg/mL of creatine. Preferably, the creatine is in monohydrate form.
Taurine is one of the osmolytes that regulate cellular volume. Therefore, the ingestion of taurine by dehydrated subjects after the ingestion of alcohol stimulates the introduction of water into the cells. Taurine also has an important physiological role, as it is a necessary component in the synthesis of bile acids, it improves the use of sugars and it increases the effectiveness of insulin, thus facilitating a rapid use of the fructose present in the supplement.
Taurine performs several actions on the body: it improves the metabolism of lipids and of sugars at the hepatic level; it facilitates the renal excretion of toxic substances; it facilitates the contractility of the skeletal muscle and of the heart, increasing its cardiac output. It is therefore recommended for increasing physiological performance and reducing recovery times.
Some studies on the use of taurine have shown a role in reducing muscular fatigue, leading to benefits in temperature control (helping to stabilize body temperature during physical activity) and in concentration. It is often incorrectly claimed that taurine is an energy stimulant, but in reality it can have an opposite action, since it is involved in inhibiting the exciter neurons of the brain, which rather makes it a relaxant. Taurine is in fact an amino acid that calms the nervous system, because it supports the production of gamma-aminobutyric acid (GABA). It can facilitate the management of anxiety, potentially counteracting stress hormones. Its use as an ingredient in the formulation of the supplement facilitates temperature control and improves concentration.
The food supplement of the present invention comprises taurine in a quantity of 0.2 mg/mL to 40 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 10 mg/mL of taurine.
Caffeine has many effects on the human body and is capable of reducing the sense of tiredness, increasing alertness and stimulating intestinal motility, promoting a general state of wellbeing, both physiological and neurological.
Caffeine has a stimulating action on the central nervous system (CNS), on the cardiovascular apparatus, on the release of catecholamines, on the synthesis of gastric acid and on the metabolism in general. Furthermore, caffeine produces an increase in the state of wakefulness and of alertness, of the capacity for concentration, and general enhancement of physical and mental efficiency. As well as the excitatory activity, which is very good for counteracting the exhaustion typical of a hangover, caffeine also has a vasoconstricting action, which produces a slight analgesic effect, and can therefore be exploited to act against the headache caused by vasodilatation in the brain.
The activity of caffeine is supported by the inotrope action of taurine which, like caffeine, acts on the muscles and on the nervous system.
The food supplement of the present invention comprises caffeine in a quantity of 0.2 mg/mL to 40 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 8 mg/mL of caffeine.
The food supplement of the present invention also comprises ashwagandha (withania somnifera) root extract in its active ingredients. Ashwagandha has neuro-protective properties and an adaptogenic and anxiolytic activity that can help the subject to overcome the phenomena of anxiety and depression that are typical of the effects of a hangover, owing to the action of alcohol and acetaldehyde on the central nervous system. Most of the properties ascribed to ashwagandha are in particular due to the withanolides (steroidal lactones) contained in it.
At the base of the adaptogenic properties of ashwagandha there seems to be an inhibition of the up-regulation of the dopaminergic receptors in the striate body which is induced by stress, for example the stress owing to intoxication by alcohol.
Ashwagandha also has an anticonvulsant activity, which is probably related to an interaction with the receptor of the barbiturates present in the receptor for GABA.
Ashwagandha also improves mood tone, thus reducing the irritability and impatience that are typical of the effects of a hangover.
The food supplement of the present invention comprises ashwagandha extract in a quantity of 0.04 mg/mL to 20 mg/mL, preferably with a content of 0.002 mg/mL to 1.2 mg/mL of withanolides. In a preferred embodiment, the food supplement of the present invention comprises 1.6 mg/mL of ashwagandha extract, preferably with a content of 0.08 mg/mL of withanolides. The ashwagandha extract can for example be the KSM-66® product marketed by Ixoreal Biomed.
Milk thistle (silybum marianum) fruit extract has effects on the digestive function and on the hepatic function, and it carries out a purifying and antioxidant function. In particular, silymarin, a complex of bioflavonoids called flavonolignans contained in milk thistle extract, carries out a defense function against many toxic substances, including alcohol. Milk thistle extract is also an antioxidant that prevents the oxidation of lipids and the destruction of cellular membranes.
The hepatoprotective effect of milk thistle extract is given by the acceleration of the liver regeneration process. Furthermore, milk thistle extract increases the metabolic activity of the hepatic cells. Therefore it facilitates the excretory system and detoxification in general. In effect, the silymarin contained in it stimulates protein synthesis and regeneration of the hepatic parenchyma.
The food supplement of the present invention comprises milk thistle extract in a quantity of 0.04 mg/mL to 20 mg/mL, preferably with a content of 0.032 mg/mL to 16 mg/mL of silymarin. In a preferred embodiment, the food supplement of the present invention comprises 0.2 mg/mL of milk thistle extract, preferably with a content of 0.16 mg/mL of silymarin.
Willow (salix alba) extract, by virtue of its anti-inflammatory activity, counteracts the headache owing to the generalized inflammation in the brain caused by alcohol intoxication and localized vasodilatation.
Willow extract is rich in tannins, flavonoids, glycosides and esters which, by hydrolysis, produce salicylic acid, in particular from a phenolic glycoside called salicin. The anti-inflammatory activity of willow is given not just by salicin, but also by other phenolic glycosides that act as prodrugs of salicylic acid. Salicylic acid further inhibits the formation of inflammatory mediators. However, unlike aspirin (acetylsalicylic acid), salicin does not irreversibly inhibit platelet aggregation.
The food supplement of the present invention comprises willow extract in a quantity of 0.04 mg/mL to 20 mg/mL, preferably with a content of 0.006 mg/mL to 3 mg/mL of salicin. In a preferred embodiment, the food supplement of the present invention comprises 0.4 mg/mL of willow extract, preferably with a content of 0.06 mg/mL of salicin.
B group vitamins activate the metabolism and counteract the feeling of exhaustion.
In particular, vitamin B12 contributes to energy metabolism and to the reduction of tiredness and fatigue, to the operation of the nervous system, to normal psychological functioning, to the metabolism of homocysteine and to the formation of red blood cells, it intervenes in the process of cell division, and it contributes to the functioning of the immune system. Vitamin B6 has an antiemetic action, it counteracts feelings of nausea, and it restores hormonal activity altered by the effects of alcohol. Vitamin B6 further contributes to the normal synthesis of cysteine, to achieving normal energy metabolism, to the operation of the nervous system, to the metabolism of homocysteine, to the metabolism of proteins and of glycogen, and to psychological functioning. Vitamin B6 also contributes to the formation of red blood cells, to the functioning of the immune system, and to reducing tiredness and fatigue. Finally, vitamin B6 contributes to the regulation of hormonal activity.
Vitamin Bl (thiamine) contributes to energy metabolism, to cardiac function, to the operation of the nervous system and to psychological functioning.
The dosage of the vitamins in the supplement of the present invention is particularly significant with respect to the Nutrient Reference Value (NRV). Their action is very rapid as they are water-soluble vitamins, and the doses used in the present invention are safe as well as effective since, although high, such doses are lower than the maximum recommended daily intake and any excess can be easily eliminated by the body.
The food supplement of the present invention comprises vitamin B12 in a quantity of 0.04 μg/mL to 8 μg/mL. In a preferred embodiment, the food supplement of the present invention comprises 0.6 μg/mL of vitamin B12.
The food supplement of the present invention comprises vitamin B6 in a quantity of 0.04 mg/mL to 6 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 168 μg/mL of vitamin B6.
The food supplement of the present invention comprises vitamin Bl in a quantity of 0.04 mg/mL to 4 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 99 μg/mL of vitamin Bl . The fructose contained in the formulation of the supplement according to the invention is rapidly absorbed and converted to glucose, in this manner counteracting the hypoglycemia.
The food supplement of the present invention comprises fructose in a quantity of 10 mg/mL to 400 mg/mL. In a preferred embodiment, the food supplement of the present invention comprises 200 mg/mL of fructose.
The food supplement according to the invention can furthermore contain one or more excipients. Such excipients can be selected from the group consisting of flavorings (for example pear flavoring), thickeners (for example xanthan gum, preferably in an amount of about 1-100 mg/mL i.e. 0.1-10% w/v, more preferably 5 mg/mL i.e. 0.5% w/v), acidifiers (for example citric acid), preservatives (for example potassium sorbate and/or sodium benzoate) and sweeteners (for example sucralose and/or steviol glycosides).
The active ingredients and any excipients of the supplement according to the present invention are contained in a physiologically acceptable carrier, preferably water, for example osmotic water.
In a preferred embodiment, the energizing food supplement according to the invention comprises, more preferably is essentially constituted by, and even more preferably is constituted by:
- 10 mg/mL of creatine monohydrate,
- 10 mg/mL of taurine,
- 8 mg/mL of caffeine,
- 1.6 mg/mL of ashwagandha (Withania somnifera) extract, of which 0.08 mg/mL withanolides,
- 0.2 mg/mL of milk thistle (Silybum marianum) extract, of which 0.16 mg/mL silymarin,
- 0.4 mg/mL of willow (Salix alba) extract, of which 0.06 mg/mL salicin,
- 0.6 μg/mL of vitamin B12, - 168 μg/mL of vitamin B6,
- 99 μg/mL of vitamin B 1 ,
- 200 mg/mL of fructose, and
- excipients consisting of a combination of an aroma, xanthan gum, potassium sorbate, sodium benzoate, sucralose and steviol glycosides,
in a physiologically acceptable vehicle constituted by osmotic water.
Preferably the energizing food supplement according to the invention can be formulated in a ready-to-use solution. In particular, the food supplement according to the invention can be supplied in phials, or other container suitable for use, preferably in a 25 mL dose.
Another aspect of the present invention relates to the energizing food supplement according to the invention for use in the prevention and treatment of the effects of a hangover. In particular, the effects of a hangover comprise tiredness, headache, nausea, difficulty concentrating, sensitivity to light and noise, and insomnia.
The energizing food supplement is taken preferably upon awakening, preferably with a 25 mL dose.
Within this aspect, the present invention also relates to a method for preventing and treating the effects of a hangover by way of the administration to a subject who needs it of an energizing food supplement as described herein.
In practice it has been found that the energizing food supplement according to the invention is effective in alleviating the effects of a hangover, such as in particular tiredness, headache and ability to concentrate, by virtue of the combined action of its active ingredients.
In particular, the food supplement according to the invention counteracts headache by virtue of the vasoconstricting action induced by the caffeine, helps rapidly to reactivate the metabolism by virtue of the high doses of vitamins B6, B 12 and Bl, counteracts dehydration by virtue of the taurine, reduces pain and headache by virtue of the action of the willow, and helps to counteract anxiety and stress by contributing to a rapid restoration of mental and physical wellness by virtue of the ashwagandha.
Furthermore, the food supplement according to the invention has a hepatoprotective action, by virtue of the taurine which contributes to the liver function, and the silymarin, which counteracts the damage caused by alcohol. The taurine and the milk thistle eliminate the free radicals due to intoxication and have a protective action on the liver, facilitating its activity.
The disclosures in Italian Patent Application No. 102017000119556 from which this application claims priority are incorporated herein by reference.

Claims

1. An energizing food supplement, particularly for preventing or treating the effects of a hangover, which comprises:
- 0.2 mg/mL to 40 mg/mL of creatine,
- 0.2 mg/mL to 40 mg/mL of taurine,
- 0.2 mg/mL to 40 mg/mL of caffeine,
- 0.04 mg/mL to 20 mg/mL of ashwagandha (Withania somnifera) extract,
- 0.04 mg/mL to 20 mg/mL of milk thistle (Silybum marianum) extract,
- 0.04 mg/mL to 20 mg/mL of willow (Salix alba) extract,
- 0.04 μg/mL to 8 μg/mL of vitamin B12,
- 0.04 mg/mL to 6 mg/mL of vitamin B6,
- 0.04 mg/mL to 4 mg/mL of vitamin B l,
- 10 mg/mL to 400 mg/mL of fructose,
and optionally one or more excipients, in a physiologically acceptable carrier.
2. The food supplement according to claim 1, comprising 10 mg/mL of creatine.
3. The food supplement according to claim 1 or 2, comprising 10 mg/mL of taurine.
4. The food supplement according to any one of the preceding claims, comprising 8 mg/mL of caffeine.
5. The food supplement according to any one of the preceding claims, comprising 1.6 mg/mL of ashwagandha (Withania somnifera) extract.
6. The food supplement according to any one of the preceding claims, comprising 0.2 mg/mL of milk thistle (Silybum marianum) extract.
7. The food supplement according to any one of the preceding claims, comprising 0.4 mg/mL of willow (Salix alba) extract.
8. The food supplement according to any one of the preceding claims, comprising 0.6 μg/mL of vitamin B12.
9. The food supplement according to any one of the preceding claims, comprising 168 μg/mL of vitamin B6.
10. The food supplement according to any one of the preceding claims, comprising 99 μg/mL of vitamin B 1.
11. The food supplement according to any one of the preceding claims, comprising 200 mg/mL of fructose.
12. The food supplement according to any one of the preceding claims, comprising:
- 10 mg/mL of creatine,
- 10 mg/mL of taurine,
- 8 mg/mL of caffeine,
- 1.6 mg/mL of ashwagandha (Withania somnifera) extract, of which 0.08 mg/mL withanolides,
- 0.2 mg/mL of milk thistle (Silybum marianum) extract, of which
0.16 mg/mL silymarin,
- 0.4 mg/mL of willow (Salix alba) extract, of which 0.06 mg/mL salicin,
- 0.6 μg/mL of vitamin B12,
- 168 μg/mL of vitamin B6,
- 99 μg/mL of vitamin B 1 ,
- 200 mg/mL of fructose, and
- excipients consisting of a combination of an aroma, xanthan gum, potassium sorbate, sodium benzoate, sucralose and steviol glycosides,
in osmotic water.
13. The food supplement according to any one of claims 1 to 12 for use in the prevention and treatment of the effects of a hangover.
14. The food supplement for use according to claim 13, wherein the hangover effects are selected from the group consisting of tiredness, headache, nausea, difficulty concentrating, sensitivity to light and noise, and insomnia.
EP18800050.9A 2017-10-23 2018-10-23 Energizing food supplement and use thereof Pending EP3700358A1 (en)

Applications Claiming Priority (2)

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IT102017000119556A IT201700119556A1 (en) 2017-10-23 2017-10-23 Energizing food supplement and its use.
PCT/EP2018/078969 WO2019081468A1 (en) 2017-10-23 2018-10-23 Energizing food supplement and use thereof

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AU2005229008B2 (en) * 2004-03-23 2011-03-24 Lifeline Nutraceuticals Corporation Compositions and method for alleviating inflammation and oxidative stress in a mammal
US7879374B2 (en) * 2005-07-22 2011-02-01 Cellutions, LLC Composition including superoxide dismutase and prickly-pear cactus for minimizing and preventing hangovers
US8137712B2 (en) * 2006-08-09 2012-03-20 Evan Hays Rehydration beverage
US20080233245A1 (en) * 2007-03-19 2008-09-25 Lesley Joan White Liquid nutrient composition for improving performance
US20100316735A1 (en) * 2009-04-10 2010-12-16 Wade Belliston Compositions and methods for reducing hangover symptoms
US20110091606A1 (en) * 2009-09-23 2011-04-21 Todd Ehrlich Dietary Supplements in Beverages or Other Forms, and Methods of Use and Production
US20130323323A1 (en) * 2012-05-31 2013-12-05 David T. Colina Therapeutic Method and Associated Compound for Augmenting the Liver's Metabolization of Oxygen-Modified Toxins
KR102209339B1 (en) * 2012-11-30 2021-01-29 주식회사유한양행 Composition for relieving and preventing hangover comprising Dendropanax morbifera extract

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