ITMI20112319A1 - PROBIOTIC COMPOSITION INCLUDING SACCAROMICES CEREVISIAE - Google Patents
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Description
COMPOSIZIONE PROBIOTICA COMPRENDENTE SACCAROMICES CEREVISIAE PROBIOTIC COMPOSITION INCLUDING SACCAROMICES CEREVISIAE
DESCRIZIONE DESCRIPTION
CAMPO DELL’INVENZIONE FIELD OF INVENTION
La presente invenzione riguarda una composizione probiotica. In particolare la presente invenzione riguarda una composizione probiotica comprendente Saccaromyces cerevisiae, e il suo uso come agente ipocolesterolemizzante. The present invention relates to a probiotic composition. In particular, the present invention relates to a probiotic composition comprising Saccharomyces cerevisiae, and its use as a cholesterol-lowering agent.
STATO DELLA TECNICA STATE OF THE TECHNIQUE
L'OMS ha previsto che entro il 2030 le malattie cardiovascolari resteranno la principale causa di morte, che colpirà circa 23,6 milioni di persone in tutto il mondo [1], E’ stato riferito che l'ipercolesterolemia ha causato dal 1999 al 2003, il 45% degli attacchi di cuore in Europa occidentale e il 35% degli attacchi di cuore in Europa centrale e orientale [2], The WHO has predicted that by 2030 cardiovascular disease will remain the leading cause of death, affecting approximately 23.6 million people worldwide [1]. It has been reported that hypercholesterolemia has caused 2003, 45% of heart attacks in Western Europe and 35% of heart attacks in Central and Eastern Europe [2],
Il rischio di infarto à ̈ tre volte superiore nei soggetti con ipercolesterolemia, rispetto a quelli che hanno normale profilo lipidico del sangue. L'OMS ha delineato che le diete non salutari, come quelli ad alto contenuto di grassi, sale e senza zucchero, e povera di carboidrati complessi, frutta e verdura, può portare ad aumento del rischio di malattie cardiovascolari. The risk of heart attack is three times higher in people with hypercholesterolemia than in those with normal blood lipid profiles. The WHO has outlined that unhealthy diets, such as those high in fat, salt and sugar free, and low in complex carbohydrates, fruits and vegetables, can lead to increased risk of cardiovascular disease.
Le persone affette da ipercolesterolemia moderata possono permettersi di evitare l'uso di farmaci per abbassare il colesterolo attraverso la pratica del controllo della dieta o l’integrazione con probiotici e / o prebiotici. People with moderate hypercholesterolemia can afford to avoid the use of cholesterol-lowering drugs through diet control or supplementation with probiotics and / or prebiotics.
I probiotici sono definiti come “supplementi microbici viventi che conferiscono benefici alla salute dell’ospite migliorando il suo equilibrio microbico intestinale†[4], I probiotici sono generalmente raccomandati per contribuire a rafforzare i sistemi di difesa dell’ospite e nel recupero da alcune malattie. Probiotics are defined as â € œliving microbial supplements that confer health benefits of the host by improving their intestinal microbial balanceâ € [4], Probiotics are generally recommended to help strengthen the host's defense systems and recovery from some diseases.
Tuttavia, il pubblico à ̈ ancora confuso su come utilizzarli al meglio e quali probiotici siano efficaci per specifiche malattie. La letteratura scientifica riporta un sempre maggior numero di microrganismi considerati probiotici. Ci sono diverse sfide nella scelta del probiotico appropriato, compresa la diversità dei ceppi probiotici esistenti, il controllo di qualità dei prodotti probiotici disponibili in commercio e il grado di prove basate sull'evidenza per ogni malattia e probiotici. Mentre à ̈ possibile elencare le specie batteriche cui appartengono i ceppi attualmente studiati ed utilizzati, risulta impossibile fornire una lista esaustiva delle specie potenzialmente probiotiche. However, the public is still confused as to how best to use them and which probiotics are effective for specific diseases. The scientific literature reports an increasing number of microorganisms considered probiotics. There are several challenges in choosing the appropriate probiotic, including the diversity of existing probiotic strains, the quality control of commercially available probiotic products, and the degree of evidence-based evidence for each disease and probiotic. While it is possible to list the bacterial species to which the strains currently studied and used belong, it is impossible to provide an exhaustive list of potentially probiotic species.
La quasi totalità dei lavori pubblicati, nonché i documenti FAO/WHO (2001, 2002) ritengono che la capacità di un microrganismo di essere un efficace probiotico à ̈ definita sulla base della ceppo-specificità . Per esempio, Lactobacillus rhamnosus GG à ̈ un ceppo batterico specifico che si à ̈ dimostrato essere un probiotico efficace per diverse malattie diarroiche, ma altri ceppi della specie L rhamnosus potrebbero non rilevarsi probiotici altrettanto efficaci. La scelta dei ceppi deve quindi avvenire attraverso un processo si selezione rivolto ad assicurare l’identità tassonomica, le principali caratteristiche fenotipiche, la sicurezza e l'efficacia [5]. I prebiotici sono invece “substrati indigeribili di origine alimentare che stimolano selettivamente la crescita, la composizione e l'attività della microflora del tratto gastrointestinale e che quindi migliorano la salute e il benessere dell’ospite†[6]. II grado di polimerizzazione e il tipo di legame dei monomeri all’interno dei prebiotici dello stesso gruppo biochimico possono avere un profondo influsso sull’efficacia dell’azione prebiotica stessa [7-9], Almost all of the published works, as well as FAO / WHO documents (2001, 2002) believe that the ability of a microorganism to be an effective probiotic is defined on the basis of strain-specificity. For example, Lactobacillus rhamnosus GG is a specific bacterial strain that has been shown to be an effective probiotic for several diarrheal diseases, but other strains of the L rhamnosus species may not be as effective as probiotics. The choice of the strains must therefore take place through a selection process aimed at ensuring taxonomic identity, the main phenotypic characteristics, safety and efficacy [5]. Prebiotics, on the other hand, are â € œindigestible substrates of food origin that selectively stimulate the growth, composition and activity of the microflora of the gastrointestinal tract and therefore improve the health and well-being of the hostâ € [6]. The degree of polymerization and the type of bond of the monomers within the prebiotics of the same biochemical group can have a profound influence on the efficacy of the prebiotic action itself [7-9],
Quando probiotici e prebiotici sono usati in combinazione, con un’azione sinergica, sono definiti “simbiotici†. Questi nuovi alimenti, oltre a stimolare selettivamente la crescita e/o il metabolismo di ceppi microbici utili per la salute dell’ospite, determinano nell'intestino un aumento della sopravivenza e della colonizzazione dei microrganismi probiotici presenti nel prodotto. When probiotics and prebiotics are used in combination, with a synergistic action, they are defined as â € œsymbioticsâ €. These new foods, in addition to selectively stimulate the growth and / or metabolism of microbial strains useful for the health of the host, determine in the intestine an increase in the survival and colonization of the probiotic microorganisms present in the product.
L'uso di probiotici e prebiotici ha acquisito riconoscimenti scientifici solo negli ultimi anni, anche se le loro applicazioni, come gli alimenti funzionali, functional food, sono consolidati da generazioni. Nell'interesse dei loro promettenti effetti sul benessere della salute, i probiotici e prebiotici sono diventati sempre più riconosciuti come integratori per il consumo umano. The use of probiotics and prebiotics has acquired scientific recognition only in recent years, even if their applications, such as functional foods, have been consolidated for generations. In the interest of their promising health wellness effects, probiotics and prebiotics have become increasingly recognized as supplements for human consumption.
L’approccio simbiotico alla cura dell’ipercolesterolemia moderata può offrire una valida alternativa. Studi condotti in vivo su ratti, hanno infatti dimostrato una significativa diminuzione delle concentrazioni sieriche di lipidi totali, trigliceridi e colesterolo totale, nel gruppo di ratti nutriti con simbiotici rispetto a quelli a cui veniva somministrato solo il probiotico o il prebiotico [10]. The symbiotic approach to the treatment of moderate hypercholesterolemia can offer a valid alternative. In vivo studies on rats have in fact shown a significant decrease in serum concentrations of total lipids, triglycerides and total cholesterol in the group of rats fed with symbiotics compared to those given only the probiotic or prebiotic [10].
Saccaromyces cerevisiae à ̈ un lievito, un organismo unicellulare appartenente al regno dei Funghi. Si tratta di un lievito alimentare, comunemente noto come “lievito della birra†e rappresenta l’unico lievito del quale sia stata verificata l'azione probiotica. E' utilizzato nella produzione di farmaci che offrono un’importate azione nella prevenzione delle malattie intestinali e nella modulazione della risposta immunitaria. Saccaromyces cerevisiae is a yeast, a unicellular organism belonging to the kingdom of Fungi. It is a nutritional yeast, commonly known as "beer yeast" and represents the only yeast whose probiotic action has been verified. It is used in the production of drugs that offer an important action in the prevention of intestinal diseases and in the modulation of the immune response.
In termini di effetti benefici S.cerevisiae ha molte proprietà , dalle più elementari alle più avanzate. Quando ingerito fornisce il 52 % della quantità giornaliera raccomandata (RDA) di proteine, à ̈ anche ricco di fibre, vitamine del gruppo B e acido folico, à ̈ inoltre privo di glutine, il che lo rende un integratore attraente per le persone che sono intolleranti al grano. In terms of beneficial effects S.cerevisiae has many properties, from the most basic to the most advanced. When ingested it provides 52% of the recommended daily amount (RDA) of protein, is also rich in fiber, B vitamins and folic acid, and is also gluten-free, making it an attractive supplement for people who are intolerant to wheat.
Di grande rilevanza à ̈ la presenza di particolari polisaccaridi, i beta-1,3-glucani, che si à ̈ dimostrato stimolino il sistema immunitario umano grazie al legame con un recettore situato sulla superficie di alcune cellule del sistema immunitario (macrofagi, granulociti e cellule naturai killer), permettendone il riconoscimento da parte delle cellule immunitarie [11]. Mentre alcuni farmaci sono in grado di sovrastimolare il sistema immunitario del corpo durante la terapia e, quindi, non si dimostrano adatti a persone con malattie autoimmuni, i beta-glucani sembrano aiutare il sistema immunitario senza causare iperattività [12]. Sono inoltre in grado di favorire la guarigione delle ferite, prevenire le infezioni e abbassare i livelli di colesterolo LDL. In riferimento a quest’ultimo punto, sono stati studiati per i loro effetti ipocolesterolemici, tra cui: riduzione dell’assorbimento intestinale di colesterolo e acidi biliari attraverso il legame con i glucani; sostituzione nel fegato della sintesi di colesterolo con la produzione di acido biliare; fermentazione tramite batteri intestinali che li trasformano in acidi grassi a catena corta, i quali sono assorbiti andando così a inibire la sintesi epatica di colesterolo [13]. Diversi studi hanno inoltre dimostrato che i beta-glucani possono prevenire la formazione di tumori e lo sviluppo di carcinomi [14-16], Of great importance is the presence of particular polysaccharides, beta-1,3-glucans, which have been shown to stimulate the human immune system thanks to the binding with a receptor located on the surface of some cells of the immune system (macrophages, granulocytes and natural killer cells), allowing their recognition by immune cells [11]. While some drugs are capable of overstimulating the body's immune system during therapy and, therefore, are not suitable for people with autoimmune diseases, beta-glucans appear to help the immune system without causing hyperactivity [12]. They are also able to promote wound healing, prevent infections and lower LDL cholesterol levels. With reference to this last point, they have been studied for their hypocholesterolemic effects, including: reduction of intestinal absorption of cholesterol and bile acids through binding with glucans; replacement in the liver of cholesterol synthesis with the production of bile acid; fermentation by intestinal bacteria that transform them into short-chain fatty acids, which are absorbed thereby inhibiting the hepatic synthesis of cholesterol [13]. Several studies have also shown that beta-glucans can prevent the formation of tumors and the development of carcinomas [14-16],
L’utilizzo dell’aglio ( Allium sativum ) e delle sue proprietà benefiche per la salute dell’uomo ha origini molto antiche, ma vi à ̈ ancora la necessità di svelare i dettagli di questi benefici [17]. Durante l’ultima decade sono sati effettuati numerosi studi scientifici e trial clinici per determinare l’effetto del consumo dell’aglio sulla salute dell’uomo e attualmente il suo utilizzo in campo medicinale à ̈ largamente diffuso e accettato. The use of garlic (Allium sativum) and its beneficial properties for human health has very ancient origins, but there is still the need to reveal the details of these benefits [17]. During the last decade, numerous scientific studies and clinical trials have been carried out to determine the effect of garlic consumption on human health and currently its use in the medical field is widely diffused and accepted.
La maggior parte degli effetti biologici dell’aglio derivano dalla presenza dei composti solforati detti organo solfuri. I principali solfuri (82%) presenti nell’aglio fresco non contuso, integro sono i peptidi non volatili della γ-glutammilcisteina (6-glutamil-S-allil-L-cisteina) e i solfossidi della cisteina, la S-allil-4-cisteina solfossido, detta alliina, che agiscono come precursori di diversi composti. Quando i tessuti sono danneggiati, quando l’aglio viene cotto o schiacciato, questi solfossidi vengono convertiti in tiosulfonati attraverso l’azione catalitica dell’enzima alliinasi. L’alliina viene liberata dai compartimenti che la contengono e interagisce con un enzima contenuto nei vacuoli adiacenti, l’allinasi, che, attraverso una reazione di idrolisi e di immediata condensazione di un composto intermedio (acido allilsulfenilico) la trasforma in allicina. Si tratta di un composto altamente instabile e volatile che scompare velocemente per ossidazione dando luogo alla formazione di costituenti dal caratteristico odore tipici dell’aglio schiacciato e dell’olio essenziale: diallil solfuro (DAS), diallil disolfuro (DADS), diallil trisolfuro (DATS), metil allil disolfuro, metil allil trisolfuro, ditiine, ajoene. Si ritiene che un mg di alliina equivalga a 0.45 mg di allicina. Most of the biological effects of garlic derive from the presence of sulfur compounds called organ sulphides. The main sulphides (82%) present in intact fresh unbruised garlic are the non-volatile peptides of γ-glutamylcysteine (6-glutamyl-S-allyl-L-cysteine) and the sulfoxides of cysteine, S-allyl-4 -cysteine sulfoxide, called alliin, which act as precursors of various compounds. When the tissues are damaged, when the garlic is cooked or crushed, these sulfoxides are converted into thiosulfonates through the catalytic action of the enzyme alliinase. Alliin is released from the compartments that contain it and interacts with an enzyme contained in the adjacent vacuoles, the allinase, which, through a reaction of hydrolysis and immediate condensation of an intermediate compound (allylsulfenyl acid), transforms it into allicin. It is a highly unstable and volatile compound that quickly disappears by oxidation giving rise to the formation of constituents with a characteristic smell typical of crushed garlic and essential oil: diallyl sulfide (DAS), diallyl disulfide (DADS), diallyl trisulfide (DATS), methyl allyl disulfide, methyl allyl trisulfide, dithiins, ajoene. One mg of alliin is believed to be equivalent to 0.45 mg of allicin.
Quindi i prodotti tiosolfonati dell’aglio (allicina) non sono presenti in natura ma vengono prodotti dalla degradazione di un solfossido della cisteina, l’alliina. Therefore the thiosulfonated products of garlic (allicin) are not present in nature but are produced by the degradation of a sulfoxide of cysteine, alliin.
L’azione protettiva dell’aglio verso le malattie del sistema cardiovascolare à ̈ stata largamente investigata e, come numerosi studi suggeriscono, può portare alla normalizzazione del livello dei lipidi plasmatici, aumento del fibrinogeno e inibizione della pressione sanguigna. The protective action of garlic against diseases of the cardiovascular system has been extensively investigated and, as numerous studies suggest, it can lead to normalization of the plasma lipid level, increase in fibrinogen and inhibition of blood pressure.
Il meccanismo che à ̈ alla base dell’azione antiipercolesterolemizzante e antiiperlipidemizzante, sembra dipendere dall’inibizione idrossilmetilgutaril-CoA (HMG-CoA) riduttasi epatica e dal rimodellamento delle proteine piasmatiche nelle membrane cellulari [18]. The mechanism underlying the antihypercholesterolemic and antihyperlipidemic action seems to depend on the inhibition of hepatic hydroxylmethylgutaryl-CoA (HMG-CoA) reductase and on the remodeling of piasmatic proteins in cell membranes [18].
Tutte queste influenze positive dell’aglio sono dose dipendente[19]. Il management dei livelli di colesterolo piasmatico continua ad essere una questione cruciale nella prevenzione delle malattie cardiovascolari, così come l’ipercolesterolemia gioca un ruolo decisivo nella patogenesi dell'aterosclerosi e delle malattie cardiache correlate[ ]. All these positive influences of garlic are dose dependent [19]. The management of piasmatic cholesterol levels continues to be a crucial issue in the prevention of cardiovascular disease, just as hypercholesterolemia plays a decisive role in the pathogenesis of atherosclerosis and related heart disease [].
Gli effetti preventivi dell’alliina nell’ischemia miocardica isoprotenerolo indotta, sono stati studiati da Sangeetha e collaboratori [21] e in base ai loro risultati l’alliina si à ̈ rivelata in grado di ridurre la formazione di lipidi perossidi grazie all’effetto di riduzione della formazione di lipidi. The preventive effects of alliin in isoprotenerol induced myocardial ischemia were studied by Sangeetha and collaborators [21] and based on their results, alliin was found to be able to reduce the formation of lipids peroxides thanks to € ™ effect of reducing the formation of lipids.
Ackermann e colleghi [22] hanno osservato, dopo somministrazione di preparati di aglio, una diminuzione dei livelli di colesterolo totale (1.2-17.7 mg/dL e 12.4-25.4 mg/dL) dopo, rispettivamente, 1 e 3 mesi di trattamento. Ackermann and colleagues [22] observed, after administration of garlic preparations, a decrease in total cholesterol levels (1.2-17.7 mg / dL and 12.4-25.4 mg / dL) after 1 and 3 months of treatment, respectively.
L’aglio possiede inoltre la capacità di inibire gli enzimi coinvolti nella sintesi lipidica e previene l’ossidazione delle lipoproteine a bassa densità (LDL), aumentando complessivamente lo stato antiossidativo. L’ossidazione delle LDL genera infatti la produzione di vari metaboliti che innescano una cascata di eventi che portano alla formazione e alla progressione dell’ evento aterosclerotico, l’inibizione di tale processo può dunque aiutare la prevenzione delle malattie cardiovascolari [23,24] Attualmente sono disponibili in commercio numerosi farmaci prescrivibili in caso di ipercolesterolemia, fra questi, le statine. La loro assunzione, necessaria per lungo tempo non à ̈ assolutamente esente da effetti indesiderati, anche importanti. Garlic also has the ability to inhibit the enzymes involved in lipid synthesis and prevents the oxidation of low-density lipoproteins (LDL), increasing the overall antioxidative status. The oxidation of LDL in fact generates the production of various metabolites that trigger a cascade of events that lead to the formation and progression of the atherosclerotic event, the inhibition of this process can therefore help the prevention of cardiovascular diseases [23, 24] Numerous prescription drugs are currently available on the market for hypercholesterolemia, including statins. Their intake, which is necessary for a long time, is absolutely not free from undesirable effects, even important ones.
I più comuni effetti collaterale delle statine sono il dolore muscolare e la debolezza, una condizione chiamata rabdomiolisi, verosimilmente dovuta alla perdita di Coenzima Q10. The most common side effects of statins are muscle pain and weakness, a condition called rhabdomyolysis, possibly due to the loss of Coenzyme Q10.
Altro effetto evidenziato à ̈ la polineuropatia, anche conosciuta come neuropatia periferica, caratterizzata da debolezza, formicolio e dolori alle mani e ai piedi e da difficoltà a camminare. I ricercatori hanno studiato 500.000 cittadini danesi, circa il 9% della popolazione di quel Paese, e hanno scoperto che le persone che assumevano le statine più facilmente sviluppavano una polineuropatia Another highlighted effect is polyneuropathy, also known as peripheral neuropathy, characterized by weakness, tingling and pain in the hands and feet and difficulty in walking. The researchers studied 500,000 Danish citizens, about 9% of that country's population, and found that people who took statins more easily developed polyneuropathy.
II danno neurologico à ̈ spesso irreversibile e può rimanere anche dopo la sospensione dei farmaci. Neurological damage is often irreversible and can remain even after drug withdrawal.
Le vertigini sono comunemente associate all’uso delle statine, probabilmente per via della riduzione della pressione sanguigna che queste causano. Dizziness is commonly associated with the use of statins, possibly due to the reduction in blood pressure they cause.
La letteratura medica riporta una serie di casi di pancreatite. The medical literature reports a number of cases of pancreatitis.
Numerosi studi hanno mostrato connessioni tra livelli bassi di colesterolo e la depressione. Uno dei più recenti ha trovato che donne con colesterolo basso hanno il doppio di possibilità di soffrire di ansia e depressione. Numerous studies have shown connections between low cholesterol levels and depression. One of the most recent found that women with low cholesterol are twice as likely to suffer from anxiety and depression.
Scopo della presente invenzione à ̈ pertanto quello di fornire una composizione probiotica adatta uso nella terapia antiipercolesterolemizzante che non presenti gli svantaggi sopra rilevati per i farmaci noti per la medesima applicazione. The aim of the present invention is therefore to provide a probiotic composition suitable for use in antihypercholesterolemic therapy which does not present the disadvantages noted above for the drugs known for the same application.
SOMMARIO DELL’INVENZIONE SUMMARY OF THE INVENTION
L’invenzione pertanto concerne una composizione probiotica comprendente: The invention therefore concerns a probiotic composition comprising:
- Alliina; - Alliina;
- Vitamina B6; e - Vitamin B6; And
- Saccaromyces cerevisiae, - Saccharomyces cerevisiae,
in cui detta alliina à ̈ presente in una quantità che va circa da 3 a 8 %, detta vitamina B6 à ̈ presente in una quantità che va circa da 0.1 a 1 % e in cui detto Saccaromyces cerevisiae à ̈ presente in una quantità che va circa da 1 x 10<8>a 1 x 10<11>cellule/ml sulla composizione totale. in which said alliin is present in a quantity ranging from about 3 to 8%, said vitamin B6 is present in an amount ranging from about 0.1 to 1% and in which said Saccaromyces cerevisiae is present in a quantity that goes about 1 x 10 <8> to 1 x 10 <11> cells / ml on the total composition.
Sotto un altro aspetto, l’invenzione concerne la composizione probiotica secondo la presente invenzione per l’uso come agente ipocolesterolemizzante. From another aspect, the invention relates to the probiotic composition according to the present invention for use as a cholesterol-lowering agent.
Sotto ancora un altro aspetto, l’invenzione concerne un prodotto alimentare comprendente la composizione secondo l’invenzione, ed altri ingredienti adatti all’uso alimentare. Under still another aspect, the invention relates to a food product comprising the composition according to the invention, and other ingredients suitable for food use.
In una forma preferita l’invenzione riguarda un succo di frutta comprendente la composizione probiotica delia presente invenzione per l’uso come agente ipocolesterolemizzante. In a preferred form the invention relates to a fruit juice comprising the probiotic composition of the present invention for use as a cholesterol-lowering agent.
DESCRIZIONE DETTAGLIATA DELL’INVENZIONE DETAILED DESCRIPTION OF THE INVENTION
L’invenzione pertanto concerne una composizione probiotica comprendente: The invention therefore concerns a probiotic composition comprising:
- Alliina; - Alliina;
- Vitamina B6; e - Vitamin B6; And
- Saccaromyces cerevisiae, - Saccharomyces cerevisiae,
in cui detta alliina à ̈ presente in una quantità che va circa da 3 a 8 %, detta vitamina B6 à ̈ presente in una quantità che va circa da 0.1 a 1 % e in cui detto Saccaromyces cerevisiae à ̈ presente in una quantità che va circa da 1 x 10<8>a 1 x 10<11>cellule/ml sulla composizione totale. in which said alliin is present in a quantity ranging from about 3 to 8%, said vitamin B6 is present in an amount ranging from about 0.1 to 1% and in which said Saccaromyces cerevisiae is present in a quantity that goes about 1 x 10 <8> to 1 x 10 <11> cells / ml on the total composition.
Nella presente invenzione quando si impiega la definizione: In the present invention when using the definition:
“alliina†si intende comprendere un solfossido naturale costituente dell'aglio fresco. La sua biosintesi trae origine dall'amminoacido cisteina. Alliina ed isoalliina, sottoposte ad azione enzimatica da parte dell'alliinasi (alliina liasi), contenuta nel sistema di vacuoli cellulari della stessa pianta vengono convertite nei sultanati, in primis allicina passando per intermedi sulfenici. â € œalliinaâ € means to include a natural sulfoxide constituent of fresh garlic. Its biosynthesis originates from the amino acid cysteine. Alliin and isoalliine, subjected to enzymatic action by the alliinase (alliin lyase), contained in the system of cellular vacuoles of the same plant, are converted into sultanates, primarily allicin passing through sulphenic intermediates.
Gli inventori hanno sorprendentemente trovato una composizione avente alliina in una quantità che va circa da 3 a 8 %, vitamina B6 in una quantità che va circa da 0.1 a 1 % e in cui Saccaromyces cerevisiae à ̈ presente in una quantità che va circa da 1 x 10<8>a 1 x 10<11>cellule/ml sulla composizione totale risolve il problema ipercolesterolemia tuttavìa non essendo un farmaco. The inventors have surprisingly found a composition having alliin in an amount ranging from about 3 to 8%, vitamin B6 in an amount ranging from about 0.1 to 1% and in which Saccaromyces cerevisiae is present in a quantity ranging from about 1 x 10 <8> to 1 x 10 <11> cells / ml on the total composition solves the hypercholesterolemia problem, however it is not a drug.
Pertanto la composizione della presente invenzione no ha i problemi e gli effetti indesiderati sopra descritti e riscontrati per i farmaci prescrivibili in caso di ipercolesterolemia, quali ad esempio il dolore muscolare, la debolezza, la polineuropatia e le vertigini. Therefore, the composition of the present invention does not have the problems and undesirable effects described above and found for drugs that can be prescribed in case of hypercholesterolemia, such as for example muscle pain, weakness, polyneuropathy and dizziness.
Preferibilmente l’invenzione riguarda una composizione in cui detta alliina à ̈ in una quantità di circa 5 %, detta vitamina B6 à ̈ in una quantità di circa 0.5 % e detto Saccaromyces cerevisiae à ̈ in una quantità di circa 1 x 10<9>cellule/ml sulla composizione totale. Preferably, the invention relates to a composition in which said alliin is in an amount of about 5%, said vitamin B6 is in an amount of about 0.5% and said Saccaromyces cerevisiae is in a quantity of about 1 x 10 <9 > cells / ml on the total composition.
In una forma preferita l’invenzione riguarda una composizione probiotica, in cui detta composizione à ̈ in forma liquida o in forma solida per somministrazione orale. In a preferred form the invention relates to a probiotic composition, in which said composition is in liquid or solid form for oral administration.
Sotto un altro aspetto, l'invenzione concerne la composizione probiotica secondo la presente invenzione per l’uso come agente ipocolesterolemizzante. From another aspect, the invention relates to the probiotic composition according to the present invention for use as a cholesterol-lowering agent.
In una ulteriore forma di realizzazione, l’invenzione concerne un prodotto alimentare comprendente la composizione secondo l'invenzione, ed altri ingredienti adatti all'uso alimentare. In a further embodiment, the invention relates to a food product comprising the composition according to the invention, and other ingredients suitable for food use.
I prodotti alimentari secondo la presente invenzione possono comprendere la composizione probiotica ed una base alimentare. La composizione o componente probiotica può essere in forma liquida o solida, essiccata o liofilizzata a seconda delle necessità e dei tempi e delle temperature di stoccaggio, di conservazione e di trasporto. The food products according to the present invention can comprise the probiotic composition and a food base. The probiotic composition or component can be in liquid or solid form, dried or freeze-dried according to the needs and times and temperatures of storage, conservation and transport.
La base alimentare dei prodotti alimentari secondo l’invenzione può essere un succo dì frutta, un prodotto derivato del latte (per esempio un gelato, un budino o una crema), uno stabilizzatore, un’addensatore, una bevanda (per esempio, acqua, thà ̈, una bibita gasata o un “soft drink†) o uno sciroppo. The food base of the food products according to the invention can be a fruit juice, a milk product (for example an ice cream, a pudding or a cream), a stabilizer, a thickener, a drink (for example , water, tea, a carbonated drink or a â € œsoft drinkâ €) or a syrup.
In una forma preferita dei prodotti alimentari à ̈ un succo di frutta. Con succo di frutta si intende il risultato della spremitura o della riduzione in purà ̈ di frutti diversi. I succhi possono essere concentrati e richiedere quindi l'aggiunta di acqua, e hanno un preciso livello di purezza. Per la produzione di succhi di frutta si usano tecniche come l'evaporazione, essiccazione e pastorizzazione. Fra i succhi ci sono quelli di mela, arancia, arancia rossa, mandarino, pera, pesca, pompeimo, ananas, pomodoro, ribes, albicocca, uva, melograno e limone. In a preferred form of food it is a fruit juice. With fruit juice we mean the result of squeezing or purifying different fruits. The juices can be concentrated and therefore require the addition of water, and have a precise level of purity. For the production of fruit juices, techniques such as evaporation, drying and pasteurization are used. Among the juices there are those of apple, orange, blood orange, mandarin, pear, peach, pompeii, pineapple, tomato, currant, apricot, grape, pomegranate and lemon.
II termine succo di frutta fa in genere riferimento a due aree: The term fruit juice generally refers to two areas:
I succhi densi (nettari: pera, pesca, albicocca, ecc.) Thick juices (nectars: pear, peach, apricot, etc.)
I succhi liquidi (succhi al 100%: ananas, arancia, tropicale, pompeimo, ecc.) In una forma di realizzazione preferita, la composizione probiotica viene aggiunta ad un succo di frutta per ottenere un prodotto alimentare con elevate caratteristiche nutritive e con proprietà ipocolesterolemizzanti. Liquid juices (100% juices: pineapple, orange, tropical, pompeii, etc.) In a preferred embodiment, the probiotic composition is added to a fruit juice to obtain a food product with high nutritional characteristics and with cholesterol-lowering properties .
Vantaggiosamente l’invenzione concerne un prodotto alimentare sotto forma di integratore dietetico o di integratore alimentare. Advantageously, the invention relates to a food product in the form of a dietary supplement or a food supplement.
Si definiscono integratori dietetici o alimentari quei prodotti specifici volti a favorire l'assunzione di determinati principi nutritivi non presenti negli alimenti di una dieta non corretta. Dietary or food supplements are defined as those specific products aimed at promoting the intake of certain nutrients not present in the foods of an incorrect diet.
Gli integratori vengono consigliati nei casi in cui l'organismo abbia carenza di determinati alimenti: non hanno dunque proprietà curative, ma servono a integrare una normale dieta, completandola. The supplements are recommended in cases where the body has a shortage of certain foods: they therefore have no healing properties, but serve to supplement a normal diet, completing it.
Si riportano di seguito Esempi di realizzazione della presente invenzione forniti a titolo illustrativo. Examples of embodiments of the present invention, provided for illustrative purposes, are reported below.
ESEMPI EXAMPLES
Esempio 1 Example 1
Preparazione della composizione probiotica Preparation of the probiotic composition
E’ stata preparata una composizione probiotica comprendente alliina, Vitamina B6 e Saccaromyces cerevisiae. A probiotic composition was prepared comprising alliin, Vitamin B6 and Saccharomyces cerevisiae.
Tale composizione à ̈ stata preparata liofilizzando una quantità che va circa da 1 x 10<8>a 1 x 10<11>cellule/ml di cellule di Saccaromyces cerevisiae e aggiungendo alle cellule liofilizzate 5mg di Alliina e 0.5mg di vitamina B6. This composition was prepared by lyophilizing an amount ranging from about 1 x 10 <8> to 1 x 10 <11> cells / ml of Saccaromyces cerevisiae cells and adding 5mg of Alliin and 0.5mg of vitamin B6 to the lyophilized cells.
Tale base attiva può essere aggiunta e sciolta in acqua, in succo di frutta o in una qualsiasi altra bevanda per la somministrazione. This active base can be added and dissolved in water, fruit juice or any other beverage for administration.
Esempio 2 Example 2
Per valutare l’attività del probiotico nel diminuire i tassi di colesterolo 10 volontari di età compresa tra i 18 ed i 60 anni e con valori di colesterolemia >230 mg/mL, sono stati trattati per 10 giorni con Saccaromyces (più vitamina B6), una volta al giorno. To evaluate the activity of the probiotic in decreasing cholesterol levels, 10 volunteers aged between 18 and 60 years and with cholesterol values> 230 mg / mL, were treated for 10 days with Saccharomyces (plus vitamin B6) , once a day.
Tabella 1. Table 1.
Misurazione dei tassi di colesterolo nel gruppo sperimentale 1 Measurement of cholesterol levels in experimental group 1
Volontari Colesterolemia / Giorno 0 Colesterolemia/ GiornolO Volunteers Cholesterolemia / Day 0 Cholesterolemia / Day
1 320 310 1 320 310
2 320 310 2 320 310
3 220 220 3 220 220
4 260 250 4 260 250
5 320 330 5 320 330
6 290 270 6 290 270
7 340 340 7 340 340
8 300 320 8 300 320
9 260 230 9 260 230
10 300 290 10 300 290
Esempio 2: Example 2:
Per valutare l’attività del probiotico nel diminuire i tassi di colesterolo 10 volontari di età compresa tra i 18 ed i 60 anni e con valori di >230 mg/mL, sono stati trattati per 10 giorni con Saccaromyces (più vitamina B6), e alliina, una volta al giorno. To evaluate the activity of the probiotic in decreasing cholesterol levels, 10 volunteers aged between 18 and 60 years and with values of> 230 mg / mL, were treated for 10 days with Saccharomyces (plus vitamin B6), and alliin, once a day.
La colesterolemia à ̈ stata misurata prima del trattamento e al giorno 10. Cholesterol was measured before treatment and on day 10.
Tabella 2. Table 2.
Misurazione dei tassi di colesterolo nel gruppo sperimentale 2 Measurement of cholesterol levels in experimental group 2
Volontari Colesterolemia / Giorno 0 Colesterolemia / Giorno 10 Volunteers Cholesterolemia / Day 0 Cholesterolemia / Day 10
1 290 240 1 290 240
2 220 200 2 220 200
3 300 290 3 300 290
4 260 220 4 260 220
5 330 300 5 330 300
6 290 230 6 290 230
7 320 310 7 320 310
8 350 340 8 350 340
9 290 230 9 290 230
10 320 260 10 320 260
Dalla descrizione dettagliata e dagli Esempi sopra riportati, risultano evidenti i vantaggi conseguiti mediante la composizione probiotica della presente invenzione. In particolare, tale composizione probiotica si à ̈ mostrata sorprendentemente e vantaggiosamente adatta all’uso come agente ipocolesterolemìzzante senza avere gli effetti indesiderati riscontrati per i farmaci prescrivibili in caso di ipercolesterolemia. Al tempo stesso, tale composizione, può essere convenientemente impiegata per la realizzazione di prodotti alimentari ad esempio per la realizzazione di succhi di frutta. From the detailed description and the Examples reported above, the advantages achieved by the probiotic composition of the present invention are evident. In particular, this probiotic composition proved surprisingly and advantageously suitable for use as a cholesterol-lowering agent without having the undesirable effects found for prescription drugs in case of hypercholesterolemia. At the same time, this composition can be conveniently used for making food products, for example for making fruit juices.
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