ITMI20130764A1 - USE OF MONTMORILLONITE IN PATHOLOGIES THAT NEED AN IPOPROTEIC DIET - Google Patents
USE OF MONTMORILLONITE IN PATHOLOGIES THAT NEED AN IPOPROTEIC DIET Download PDFInfo
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- ITMI20130764A1 ITMI20130764A1 IT000764A ITMI20130764A ITMI20130764A1 IT MI20130764 A1 ITMI20130764 A1 IT MI20130764A1 IT 000764 A IT000764 A IT 000764A IT MI20130764 A ITMI20130764 A IT MI20130764A IT MI20130764 A1 ITMI20130764 A1 IT MI20130764A1
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- GUJOJGAPFQRJSV-UHFFFAOYSA-N dialuminum;dioxosilane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[O-2].[Al+3].[Al+3].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O GUJOJGAPFQRJSV-UHFFFAOYSA-N 0.000 title claims description 37
- 229910052901 montmorillonite Inorganic materials 0.000 title claims description 37
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- 235000021245 dietary protein Nutrition 0.000 claims description 5
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- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 2
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- IDZYHGDLWGVHQM-UHFFFAOYSA-N aluminum;calcium;sodium;silicate Chemical compound [Na+].[Al+3].[Ca+2].[O-][Si]([O-])([O-])[O-] IDZYHGDLWGVHQM-UHFFFAOYSA-N 0.000 description 2
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- 239000004475 Arginine Substances 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000011231 Crohn disease Diseases 0.000 description 1
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- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
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- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
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- 229910021529 ammonia Inorganic materials 0.000 description 1
- 238000000540 analysis of variance Methods 0.000 description 1
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- 229940088710 antibiotic agent Drugs 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 229910000278 bentonite Inorganic materials 0.000 description 1
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- SVPXDRXYRYOSEX-UHFFFAOYSA-N bentoquatam Chemical compound O.O=[Si]=O.O=[Al]O[Al]=O SVPXDRXYRYOSEX-UHFFFAOYSA-N 0.000 description 1
- 102000006995 beta-Glucosidase Human genes 0.000 description 1
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Classifications
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- 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
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
- A23L29/294—Inorganic additives, e.g. silica
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
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- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Inorganic Chemistry (AREA)
- Polymers & Plastics (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Nutrition Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Silicates, Zeolites, And Molecular Sieves (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Description
USO DELLA MONTMORILLONI TE IN PATOLOGIE CHE NECESSITANO DI UNA DIETA I POPROTEICA USE OF MONTMORILLONI TE IN PATHOLOGIES THAT REQUIRE A POPROTEIC DIET
La presente invenzione si riferisce al settore della medicina, in particolare al trattamento di patologie che necessitano di diete ipoproteiche. La presente invenzione si riferisce anche al settore della tecnologia alimentare, in particolare alla produzione di alimenti speciali per soggetti affetti da patologie croniche. The present invention relates to the field of medicine, in particular to the treatment of pathologies which require low-protein diets. The present invention also refers to the food technology sector, in particular to the production of special foods for subjects suffering from chronic pathologies.
Le proteine sono un elemento essenziale della nutrizione umana. Nella vita odierna, l’alimentazione comprende una quota proteica che in alcuni casi può essere eccessiva, con effetti negativi sulla salute. Protein is an essential element of human nutrition. In today's life, nutrition includes a protein quota which in some cases can be excessive, with negative effects on health.
L’assunzione di proteine non avviene solo con gli alimenti a chiara base proteica, quali le carni, ma anche attraverso alimenti complessi, ad esempio dolciumi, di preparazione industriale. Vi sono alcuni stati patologici che costringono il paziente a una assunzione regolata di proteine, se non addirittura a bandire alcuni elementi proteici dalla dieta. Protein intake occurs not only with foods with a clear protein base, such as meat, but also through complex foods, such as sweets, of industrial preparation. There are some pathological states that force the patient to a regulated intake of proteins, if not even to banish some protein elements from the diet.
L’insufficienza renale cronica è una malattia progressiva (da mesi ad anni) che vede il lento declino della capacità del rene di filtrare i metaboliti di scarto dal sangue. Tra le maggiori cause si citano il diabete e l’ipertensione. I l trattamento m ira alla riduzione dei fluidi, sodio e potassio nella dieta, oltra al trattamento farmacologico della patologia sottostante, fino ad arrivare alla dialisi. È importante ridurre il carico proteico che il rene deve sopportare e questo viene fatto attraverso meticolose restrizioni dietetiche anche severe (Principles of internai medicine, Harrison’s 17th ed. “Chronic Kidney Disease”, pag. 1761 -1771 ) Chronic renal failure is a progressive disease (from months to years) that sees the slow decline in the kidney's ability to filter waste metabolites from the blood. Among the major causes are diabetes and hypertension. The treatment aims at reducing the fluids, sodium and potassium in the diet, as well as the pharmacological treatment of the underlying pathology, up to the point of dialysis. It is important to reduce the protein load that the kidney has to bear and this is done through meticulous dietary restrictions, even severe ones (Principles of internai medicine, Harrison's 17th ed. "Chronic Kidney Disease", pages 1761 -1771)
I difetti del ciclo dell’urea (UCD) sono dei difetti genetici che influiscono sulla detossificazione dell’am moniaca e della sintesi dell’arginina. Si tratta di una malattia rara, dove i pazienti presentano iperam monemia immediatamente dopo la nascita, oppure in qualsiasi successiva fase della vita con esito fatale o gravi comprom issioni neurologiche, se sopravvivono. Nonostante la disponibilità di diverse terapie e del trapianto del fegato, gli esiti sono scarsi. Il trattamento acuto della iperam moniem ia prevede anche il rigoroso controllo del bilancio proteico, che deve allo stesso tempo evitare l’assunzione di proteine e il catabolismo proteico, assicurando un adeguato rifornimento energetico. I l pilastro fondamentale della gestione a lungo termine della malattia è la riduzione massima del carico azotato nel ciclo dell’urea. Il bilancio proteico è molto complesso, dovendo tener conto della risposta individuale del soggetto e della sua fase di vita (bambino, adolescente, adulto, gravidanza) . Una eccessiva restrizione proteica può essere ugualmente dannosa. Per una rassegna su questa patologia si veda Johannes Hàberle, Nathalie Boddaert, Alberto Buriina, Anupam Chakrapani, Marjorie Dixon, Martina Huemer, Daniela Karall, Diego Martinelli, Pablo Sanj urjo Crespo, René Santer, Aude Servais, Vassili Valayannopoulos, Martin Lindner, Vicente Rubio14 and Carlo Dionisi-Vici Suggested guidelines for thè diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases 2012, 7:32. Urea cycle defects (UCD) are genetic defects that affect ammonia detoxification and arginine synthesis. This is a rare disease, where patients present with hyperamonaemia immediately after birth, or at any later stage of life with a fatal outcome or severe neurological compromise if they survive. Despite the availability of various therapies and liver transplantation, the outcomes are poor. The acute treatment of hyperam monemia also involves strict control of the protein balance, which must at the same time avoid protein intake and protein catabolism, ensuring an adequate energy supply. The fundamental pillar of the long-term management of the disease is the maximum reduction of the nitrogen load in the urea cycle. The protein balance is very complex, having to take into account the individual response of the subject and his life stage (child, adolescent, adult, pregnancy). Excessive protein restriction can be equally harmful. For a review on this pathology see Johannes Hàberle, Nathalie Boddaert, Alberto Buriina, Anupam Chakrapani, Marjorie Dixon, Martina Huemer, Daniela Karall, Diego Martinelli, Pablo Sanj urjo Crespo, René Santer, Aude Servais, Vassili Valayannopoulos, Martin Lindner, Vicente Rubio14 and Carlo Dionisi-Vici Suggested guidelines for the diagnosis and management of urea cycle disorders. Orphanet Journal of Rare Diseases 2012, 7:32 am.
Le diete ipoproteiche richiedono un notevole sforzo da parte del paziente nell’osservare il regime prescritto. Gli alimenti ipoproteici sono generalmente meno appetibili e il regime di dosaggio e tempi della dieta possono indurre il paziente a sfuggire al regime prescritto. La mancata soddisfazione psicologica di una alimentazione gustosa e conviviale può esporre il soggetto a rischio di depressione e in generale ridotta qualità della vita (Haeberle KN; Psychological aspects of low protein diet therapy; Blood Purif. 1989 ; 7( 1 ) :39-42) . Low-protein diets require considerable effort on the part of the patient in observing the prescribed regimen. Low-protein foods are generally less palatable and the dosage regimen and timing of the diet can cause the patient to escape the prescribed regimen. The lack of psychological satisfaction of a tasty and convivial diet can expose the subject to risk of depression and in general reduced quality of life (Haeberle KN; Psychological aspects of low protein diet therapy; Blood Purif. 1989; 7 (1): 39-42 ).
La preparazione di pasti a basso contenuto proteico richiede una elevata conoscenza, consapevolezza e abilità. I l regime dietetico ipoproteico realizzato in ambito domestico è di faticosa realizzazione e isola il paziente dalla condivisione conviviale del pasto. Preparing low protein meals requires high knowledge, awareness and skill. T he low-protein dietary regime carried out in the home is tiring and isolates the patient from convivial sharing of the meal.
L’industria alimentare ha sviluppato una serie di pasti per diete ipoproteiche che ormai coprono potenzialmente una ampia gamma di alimenti e piatti preparati. Apparentemente, questi cibi potrebbero soddisfare anche l’aspetto psicologico del cibo. Tuttavia, le materie prime che necessariamente sono utilizzate, non riescono ancora ad offrire alimenti con un quadro organolettico soddisfacente. Bisogna anche tener conto degli aspetti culturali del cibo, e in alcune società, l’alimentazione ipoproteica incontra delle notevoli resistenze, per lo meno in un regime di assoluta costanza. The food industry has developed a series of meals for low-protein diets that now potentially cover a wide range of prepared foods and dishes. Apparently, these foods could also satisfy the psychological aspect of food. However, the raw materials that are necessarily used, still fail to offer foods with a satisfactory organoleptic framework. It is also necessary to take into account the cultural aspects of food, and in some societies, low-protein diet meets considerable resistance, at least in a regime of absolute constancy.
I noltre, bisogna anche considerare che questi alimenti sono mediamente più costosi dei normali equivalenti e, quando sono a carico del sistema sanitario nazionale, influiscono sui costi generali della sanità. Furthermore, it must also be considered that these foods are on average more expensive than normal equivalents and, when they are paid for by the national health system, they affect the general costs of health.
Allo stato attuale delle conoscenze dei presenti inventori, non esiste un modo che consenta a pazienti sottoposti a regim i dietetici ipoproteici di poter derogare, senza incorrere nel rischio di aggravare la patologia o compromettere il progresso terapeutico. In the current state of knowledge of the present inventors, there is no way that allows patients undergoing low-protein dietary regimes to be able to derogate, without running the risk of aggravating the pathology or compromising therapeutic progress.
La presente invenzione si pone l’obiettivo di risolvere i problem i noti nell’arte. The present invention aims to solve the problems known in the art.
La montmorillonite è un m inerale argilloso, composto di silicato idrato di calcio, alluminio, magnesio e sodio, a struttura lamellare con elevata capacità di assorbire acqua e gas (H2, CH4, C02) ed elevato potere di scambio cationico (Serefoglou E et al. Smectite clays as solid supports ter immobilization of beta-glucosidase: synthesis, characterization and biochem ical properties; Chem Mater 2008;20:41 06) . La struttura lamellare e la capacità di scambio cationico permettono uno stabile intrappolamento di proteine ad elevato peso molecolare (es. album ina) e di molecole a basso peso molecolare (es. aflatossine) (Marroquin-Cardona A et al. Characterization and safety of uniform particle size novasil clay as a potential aflatoxin enterosorbent. Appi Clay Sci 201 1 ; 54:248) . Per questo la montmorillonite, viene utilizzata nell’industria farmacologica ed alimentare come stabilizzante 0 additivo nella preparazione di prodotti da utilizzare in campo medico e veterinario e nell’alimentazione umana (Carretero I ., Clay minerals and their beneficiai effects upon human health; Appi Clay Sci 2002 ; 21 : 155) . Studi clinici hanno dimostrato che la somm inistrazione per os della montmorillonite m igliora il quadro clinico gastro-intestinale in soggetti con malattia di Crohn (Ducrotte P et al. Symptomaytic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a random ized, controller study; Aliment Pharmacol Ther 2005;21 :435) e sequestra le aflatossine presenti in alimenti conservati soprattutto nei paesi poveri riducendo drasticamente la messa in circolo di queste m icotossine (Wang P et al. Novasil clay intervention in Ghanaians at high risk for aflatoxicosis: reduction in biomarkers of aflatoxin exposure in blood and urine. Food Addit Contam . 2008;25: 622) . Montmorillonite is a clayey mineral, composed of hydrated silicate of calcium, aluminum, magnesium and sodium, with a lamellar structure with high capacity to absorb water and gas (H2, CH4, C02) and high cation exchange power (Serefoglou E et al . Smectite clays as solid supports ter immobilization of beta-glucosidase: synthesis, characterization and biochem ical properties; Chem Mater 2008; 20: 41 06). The lamellar structure and the cation exchange capacity allow a stable entrapment of high molecular weight proteins (e.g. album ina) and low molecular weight molecules (e.g. aflatoxins) (Marroquin-Cardona A et al. Characterization and safety of uniform particle size novasil clay as a potential aflatoxin enterosorbent. Appi Clay Sci 201 1; 54: 248). For this reason montmorillonite is used in the pharmacological and food industry as a stabilizer or additive in the preparation of products to be used in the medical and veterinary fields and in human nutrition (Carretero I., Clay minerals and their beneficiai effects upon human health; Appi Clay Sci 2002; 21: 155). Clinical studies have shown that oral administration of montmorillonite improves the gastrointestinal clinical picture in subjects with Crohn's disease (Ducrotte P et al. Symptomaytic efficacy of beidellitic montmorillonite in irritable bowel syndrome: a random ized, controller study; Aliment Pharmacol Ther 2005; 21:43) and sequesters the aflatoxins present in foods stored especially in poor countries, drastically reducing the circulation of these micotoxins (Wang P et al. Novasil clay intervention in Ghanaians at high risk for aflatoxicosis: reduction in biomarkers of aflatoxin exposure in blood and urine. Food Addit Contam. 2008; 25: 622).
Sono noti altri usi della montmorillonite nell’industria farmaceutica. Other uses of montmorillonite in the pharmaceutical industry are known.
W09620709 descrive l’uso di argille, tra le quali la bentonite per il trattamento di diarrea 0 infezioni intestinali dovute all’accumulo di acido nel tratto gastrointestinale dovuto alla fermentazione di carboidrati. W09620709 describes the use of clays, including bentonite for the treatment of diarrhea or intestinal infections due to the accumulation of acid in the gastrointestinal tract due to the fermentation of carbohydrates.
EP2386308 descrive una composizione farmaceutica per il rilascio selettivo nel tratto intestinale di adsorbenti con lo scopo di impedire l’assorbimento intestinale di un eccesso di antibiotici o di altre sostanze dannose per la flora batterica. EP2386308 describes a pharmaceutical composition for the selective release in the intestinal tract of adsorbents with the aim of preventing intestinal absorption of an excess of antibiotics or other substances harmful to the bacterial flora.
La montmorillonite è in genere utilizzata per l’assorbimento di sostanze tossiche, si veda ad esempio WO200612835. Montmorillonite is generally used for the absorption of toxic substances, see for example WO200612835.
In US20120251 589 è descritto un dispositivo contenente un materiale spugnoso che, quando ingerito, assorbe il pasto digerito nello stomaco. Tra i numerosi materiali spugnosi è citata la montmorillonite. Questo dispositivo è concepito per un assorbimento generalizzato di nutrienti con lo scopo di dim inuire la quantità di calorie assunte e viene indicato per i soggetti obesi. Sono anche noti diversi usi della montmorillonite in zootecnia, ad esempio nella preparazione di mangimi per animali da allevamento e consumo umano. CN102669496 descrive l’utilizzo di questa argilla per dim inuire l’assorbimento intestinale di micotossine. US20120251 589 discloses a device containing a spongy material which, when ingested, absorbs the digested meal in the stomach. Montmorillonite is mentioned among the numerous spongy materials. This device is designed for a generalized absorption of nutrients with the aim of decreasing the amount of calories consumed and is indicated for obese subjects. Various uses of montmorillonite in animal husbandry are also known, for example in the preparation of feed for farm animals and human consumption. CN102669496 describes the use of this clay to decrease the intestinal absorption of mycotoxins.
I n enologia l’argilla viene usata per chiarificare i mosti e anche nei vini pronti per l’imbottigliamento in quanto un suo dosaggio intorno ai 50 gr per ettolitro di vino ne permette la stabilità proteica. In enology clay is used to clarify musts and also in wines ready for bottling as its dosage of around 50 grams per hectolitre of wine allows protein stability.
Lo stato dell’arte non dà alcuna indicazione o suggerimento sul possibile ruolo della montmorillonite in un efficace e controllato assorbimento di proteine in una matrice complessa come un alimento. The state of the art does not give any indication or suggestion on the possible role of montmorillonite in an effective and controlled absorption of proteins in a complex matrix such as a food.
Som mario dell’invenzione Summary of the invention
È stato ora trovato che introducendo una opportuna quantità di montmorillonite negli alimenti si può ovviare ai problemi sopra esposti grazie alla sua proprietà di legare le proteine. It has now been found that by introducing an appropriate quantity of montmorillonite into food, the above problems can be overcome thanks to its protein binding property.
Pertanto, è oggetto della presente invenzione la montmorillonite per uso nella riduzione delle proteine alimentari in un soggetto, in particolare un soggetto umano. Therefore, the subject of the present invention is montmorillonite for use in the reduction of dietary proteins in a subject, in particular a human subject.
I n una realizzazione della presente invenzione, tale soggetto è affetto da una patologia che richiede una dieta ipoproteica, ad esempio insufficienza renale cronica, malattia metabolica, quale difetti del ciclo dell’urea. In an embodiment of the present invention, this subject is affected by a pathology that requires a low-protein diet, for example chronic renal failure, metabolic disease, such as defects in the urea cycle.
La presente invenzione fornisce anche un metodo per sequestrare in maniera stabile le proteine da un alimento. Tale metodo comprende la som ministrazione un soggetto che necessita di una diminuzione dell’assorbimento proteico, ad esempio nel caso di una dieta ipoproteica che può essere resa necessaria in una situazione patologica come visto sopra, di una quantità efficace di montmorillonite. The present invention also provides a method for stably sequester proteins from a food. This method includes administering an effective amount of montmorillonite to a subject who needs a decrease in protein absorption, for example in the case of a low-protein diet that may be required in a pathological situation as seen above.
La presente invenzione sarà ora descritta in dettaglio anche per mezzo di esempi e figure. Nelle figure 1 e 2 sono mostrati i grafici del risultato dell’esperimento descritto nell’Esempio 2. La montmorillonite può essere som ministrata in qualsivoglia forma. Ad esempio può essere semplicemente aggiunta all’alimento, oppure può essere incorporata in esso, sia prima o durante la sua preparazione, inclusa la cottura. Questo vale anche per la preparazione di alimenti industriali. The present invention will now be described in detail also by means of examples and figures. Figures 1 and 2 show the graphs of the result of the experiment described in Example 2. Montmorillonite can be administered in any form. For example, it can be simply added to food, or it can be incorporated into it, either before or during its preparation, including cooking. This also applies to the preparation of industrial food.
I n alternativa, la montmorillonite può essere somm inistrata in una formulazione di tipo farmaceutico adatta alla som ministrazione orale, ad esempio compressa, capsula, granulato, sospensione già pronta. Alternatively, montmorillonite can be administered in a pharmaceutical type formulation suitable for oral administration, for example tablet, capsule, granulate, ready-made suspension.
I n una realizzazione esemplificativa della presente invenzione, i rapporti (peso/peso) tra montmorillonite e proteine nel pasto som ministrato possono variare tra 1 :3 e 1 : 15. Tali rapporti possono essere regolati a seconda del contenuto proteico del pasto som ministrato. Secondo la presente invenzione, la montmorillonite può essere som ministrata in vari modi: in concomitanza del pasto, oppure prima o dopo il pasto. In questi ultimi due casi, si terrà in considerazione il tipo e la quantità di pasto, il suo tempo di digestione e transito. Si avrà cura di som ministrare la montmorillonite non troppo prima del pasto, per evitare che la montmorillonite non entri in contatto con quest’ultimo; e nem meno non troppo dopo il pasto, per evitare che il processi di digestione e assorbimento proteico sia iniziato. In an exemplary embodiment of the present invention, the ratios (weight / weight) between montmorillonite and proteins in the administered meal can vary between 1: 3 and 1: 15. These ratios can be adjusted according to the protein content of the administered meal. According to the present invention, montmorillonite can be administered in various ways: concurrently with the meal, or before or after the meal. In the latter two cases, the type and quantity of the meal, its digestion and transit time will be taken into consideration. Care will be taken to administer the montmorillonite not too long before the meal, to prevent the montmorillonite from coming into contact with the latter; and even not too long after the meal, to prevent the process of digestion and protein absorption from starting.
La presente invenzione offre il vantaggio di consentire a soggetti che soffrono di patologie per le quali devono sottostare a un stretto regime dietetico ipoproteico di poter godere di un pasto normale e maggiormente appetibile, ristabilendo, almeno momentaneamente il piacere psicologico e conviviale. The present invention offers the advantage of allowing subjects suffering from pathologies for which they must undergo a strict low-protein diet to be able to enjoy a normal and more palatable meal, restoring, at least momentarily, the psychological and convivial pleasure.
I soggetti che possono usufruire della presente invenzione generalmente soffrono delle suddette patologie, ad esempio insufficienza renale o malattie metaboliche, ad esempio difetti del ciclo dell’urea. The subjects who can take advantage of the present invention generally suffer from the aforementioned pathologies, for example renal insufficiency or metabolic diseases, for example defects in the urea cycle.
Non va trascurato il beneficio economico sia per i pazienti, sia per i servizi sanitari pubblici derivante dalla minor spesa in alimenti speciali. The economic benefit for both patients and public health services deriving from lower spending on special foods should not be overlooked.
La presente invenzione si applica anche a quei soggetti che comunque intendono seguire una dieta ipoproteica. The present invention also applies to those subjects who, in any case, intend to follow a low-protein diet.
In una realizzazione della presente invenzione, la montmorillonite può essere convenientemente incorporata in un prodotto alimentare, in una quantità efficace a produrre il desiderato abbattimento dell’assorbimento proteico. In an embodiment of the present invention, montmorillonite can be conveniently incorporated into a food product, in an amount effective to produce the desired reduction in protein absorption.
Ad esempio il prodotto è scelto nel gruppo costituito da prodotti secchi e prodotti surgelati, pasta, pane e suoi sostituti, ad esempio pane a cassetta, piadina, grissini, crackers, fette biscottate, cereali in fiocchi, pasta in tutti i formati, dolci, ad esempio biscotti secchi e farciti, plum-cake, torte e tortine, merendine e vari prodotti da forno, farine, dessert, gelati, semifreddi, piatti pronti, sia precotti, semicotti o da cuocere. For example, the product is chosen from the group consisting of dry products and frozen products, pasta, bread and its substitutes, for example loaf bread, flatbread, breadsticks, crackers, rusks, cereal flakes, pasta in all shapes, desserts, for example dry and stuffed biscuits, plum-cakes, cakes and pies, snacks and various baked goods, flours, desserts, ice creams, semifreddo, ready meals, whether pre-cooked, semi-cooked or to be cooked.
Un’altra realizzazione della presente invenzione comprende una confezione di un prodotto alimentare e/o di un condimento per prodotto alimentare, eventualmente comprendente montmorillonite, detta confezione comprendente inoltre una form ulazione di montmorillonite per assunzione orale. Another embodiment of the present invention comprises a package of a food product and / or a seasoning for a food product, possibly comprising montmorillonite, said package also comprising a montmorillonite formulation for oral intake.
I n una realizzazione dell’invenzione, la montmorillonite può essere formulata negli alimenti per la prima infanzia, ad esempio i sostituti del latte materno. In one embodiment of the invention, montmorillonite can be formulated in foods for infants, such as breast milk substitutes.
I seguenti esempi illustrano ulteriormente l’invenzione. The following examples further illustrate the invention.
Esempio 1 Example 1
Prove in-vitro In-vitro tests
Sono stati preparati campioni di montmorillonite e proteine liofilizzate del siero di latte vaccino per alimentazione umana (whey protein) nei rapporti p/p 1 :3, 1 : 5, 1 : 15 e un campione di sola proteina. I campioni sono stati disciolti in tampone acetato 0,1 M pH 5 e incubati con scuotimento a temperatura ambiente per 1 , 10, 30 e 60 m inuti. Dopo centrifugazione delle m iscele a 13.000 g e recupero del surnatante, è stata misurata la quantità di proteina libera, mediante metodo colorimetrico di Lowry (J Biol Chem . 1951 Nov; 193(1 ) :265-75). La concentrazione proteica è espressa in mg/m l. I l grado di assorbimento di montmorillonite nei differenti rapporti è stato confrontato con il campione proteico di controllo, e le differenze sono state valutate statisticamente con il t test. Samples of montmorillonite and lyophilized cow's milk whey proteins for human consumption (whey protein) in the ratios w / w 1: 3, 1: 5, 1: 15 and a sample of protein alone were prepared. The samples were dissolved in 0.1 M acetate buffer pH 5 and incubated with shaking at room temperature for 1, 10, 30 and 60 minutes. After centrifugation of the mixtures at 13,000 g and recovery of the supernatant, the amount of free protein was measured by Lowry's colorimetric method (J Biol Chem. 1951 Nov; 193 (1): 265-75). The protein concentration is expressed in mg / m l. The degree of montmorillonite absorption in the different ratios was compared with the control protein sample, and the differences were statistically evaluated with the t test.
La montmorillonite trattiene in maniera stabile le proteine alimentari beta-lattoglobuline, alfa lattoalbu mine, e con i rapporti montmorillonit e- proteine (p/p) pari a 1 :3, 1 : 5, 1 : 15 si ottiene un sequestro proteico rispettivamente del 50, 27 e 0 % . Montmorillonite stably retains the food proteins beta-lactoglobulins, alpha lactoalbumin, and with the montmorillonit and- protein ratios (w / w) equal to 1: 3, 1: 5, 1: 15, a protein sequestration is obtained respectively of the 50, 27 and 0%.
Esempio 2 Example 2
Studio in vivo In vivo study
Su consenso informato, sono stati arruolati 25 volontari sani d’età compresa tra 25 e 30 anni (12 M e 13F) . Upon informed consent, 25 healthy volunteers between the ages of 25 and 30 (12 M and 13F) were enrolled.
Tutti i soggetti hanno iniziato lo studio a digiuno al mattino e sono stati suddivisi in 4 gruppi: 10 soggetti hanno consumato un pasto standard di proteine (whey protein) (15gr in 200 m i di acqua) ; 5 una m iscela composta da montmorillonite proteine (5gr 15gr, 1 :3) ; 5 una m iscela composta da montmorillonite proteine (3gr 15gr, 1 : 5) ; 5 una m iscela composta da montmorillonite proteine ( 1 g r 15gr, 1 : 15) . I noltre 5 soggetti del gruppo 1 : 5 hanno eseguito un cross-over con la somm inistrazione di 15 gr di proteine. Un gruppo di controllo ha consumato 15g r di sola proteina. Ad ogni volontario è stata inserita un’ago-cannula (vena dorsale della mano) la quale permette di eseguire sei prelievi da tre mi (18 m i totali) . I prelievi sono stati eseguiti con il seguente schema: prima del consumo della m iscela; e a 30, 60, 90, 120, 180 minuti dopo il consumo delle miscele. I prelievi sono stati centrifugati e il plasma congelato in due aliquote a -80°C. I cinque soggett i valutati una prima volta per il rapporto 1 : 5 montmorillonite-proteine, sono stati successivamente valutati a distanza di 30 giorni, con la som ministrazione della sola proteina (15gr) per verificare il reale effetto della montmorillonite sugli stessi individui. All subjects began the study fasting in the morning and were divided into 4 groups: 10 subjects ate a standard whey protein meal (15g in 200m of water); 5 a mixture composed of montmorillonite proteins (5gr 15gr, 1: 3); 5 a mixture composed of montmorillonite proteins (3gr 15gr, 1: 5); 5 a mixture composed of montmorillonite proteins (1 g r 15gr, 1: 15). The more than 5 subjects of the 1: 5 group performed a cross-over with the administration of 15 g of protein. A control group consumed 15g r of protein alone. A needle-cannula (dorsal vein of the hand) was inserted for each volunteer, which allows them to perform six three-ml samples (18 m total). The samples were taken according to the following scheme: before the consumption of the mixture; and at 30, 60, 90, 120, 180 minutes after the consumption of the mixtures. The samples were centrifuged and the plasma frozen in two aliquots at -80 ° C. The five subjects evaluated for the first time for the 1: 5 montmorillonite-protein ratio, were subsequently evaluated after 30 days, with the administration of the protein alone (15gr) to verify the real effect of montmorillonite on the same individuals.
I campioni di plasma sono stati analizzati mediante spettrometria di massa (Agilent HP5973 Mass Spectrometry) per misurare la concentrazione di 12 am inoacidi (ALA, GLY, LEU, PHE, Ac GLU, GLU, TYR, THR, SER, PRO, CYS, MET) nei 6 campioni di plasma di ogni soggetto (J.Nutr. Plasma samples were analyzed by mass spectrometry (Agilent HP5973 Mass Spectrometry) to measure the concentration of 12 am inoacids (ALA, GLY, LEU, PHE, Ac GLU, GLU, TYR, THR, SER, PRO, CYS, MET ) in the 6 plasma samples of each subject (J.Nutr.
2008; 138:2212) . Le concentrazioni piasmatiche di ogni am inoacido sono state confrontate fra i gruppi dello studio e valutate statisticamente mediante ANOVA test. 2008; 138: 2212). The piasmatic concentrations of each amino acid were compared between the study groups and statistically evaluated by ANOVA test.
I dati mostrano una riduzione degli aminoacidi, che e’ una diretta conseguenza della riduzione dell’assorbimento del pasto proteico. The data show a reduction in amino acids, which is a direct consequence of the reduction in the absorption of the protein meal.
Claims (10)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT000764A ITMI20130764A1 (en) | 2013-05-10 | 2013-05-10 | USE OF MONTMORILLONITE IN PATHOLOGIES THAT NEED AN IPOPROTEIC DIET |
| PCT/IB2013/058255 WO2014037877A1 (en) | 2012-09-04 | 2013-09-03 | Food product or a seasoning thereof containing bentonite or montmorillonite having activity of metabolic protein load reduction |
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| IT000764A ITMI20130764A1 (en) | 2013-05-10 | 2013-05-10 | USE OF MONTMORILLONITE IN PATHOLOGIES THAT NEED AN IPOPROTEIC DIET |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2443138A (en) * | 1943-11-06 | 1948-06-08 | American Colloid Co | Preservation of baked cereal food |
| WO2000001241A1 (en) * | 1998-07-06 | 2000-01-13 | Süd-Chemie AG | Use of bentonites as additives to flour and dough |
| CN1720924A (en) * | 2003-04-17 | 2006-01-18 | 周良震 | Application of montmorillonite in pharmacy |
| WO2013010674A1 (en) * | 2011-07-20 | 2013-01-24 | Qiagen Gmbh | Filtering devices comprising clay minerals |
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2013
- 2013-05-10 IT IT000764A patent/ITMI20130764A1/en unknown
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2443138A (en) * | 1943-11-06 | 1948-06-08 | American Colloid Co | Preservation of baked cereal food |
| WO2000001241A1 (en) * | 1998-07-06 | 2000-01-13 | Süd-Chemie AG | Use of bentonites as additives to flour and dough |
| CN1720924A (en) * | 2003-04-17 | 2006-01-18 | 周良震 | Application of montmorillonite in pharmacy |
| WO2013010674A1 (en) * | 2011-07-20 | 2013-01-24 | Qiagen Gmbh | Filtering devices comprising clay minerals |
Non-Patent Citations (3)
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| MARTIN WILLIAM F ET AL: "Dietary protein intake and renal function", NUTRITION & METABOLISM, BIOMED CENTRAL. LONDON, GB, vol. 2, no. 1, 20 September 2005 (2005-09-20), pages 25, XP021010978, ISSN: 1743-7075, DOI: 10.1186/1743-7075-2-25 * |
| RAMU J ET AL: "Adsorption of cholera and heat-labile Escherichia coli enterotoxins by various adsorbents: An in vitro study", JOURNAL OF FOOD PROTECTION, INTERNATIONAL ASSOCIATION FOR FOOD PROTECTION, US, vol. 60, no. 4, 1 April 1997 (1997-04-01), pages 358 - 362, XP008087171, ISSN: 0362-028X * |
| SAUVAGE F X ET AL: "Proteins in white wines: Thermo-sensitivity and differential adsorbtion by bentonite", FOOD CHEMISTRY, ELSEVIER LTD, NL, vol. 118, no. 1, 1 January 2010 (2010-01-01), pages 26 - 34, XP026460561, ISSN: 0308-8146, [retrieved on 20090305], DOI: 10.1016/J.FOODCHEM.2009.02.080 * |
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