IT202100014036A1 - Composition or kit for weight loss. - Google Patents
Composition or kit for weight loss. Download PDFInfo
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- IT202100014036A1 IT202100014036A1 IT102021000014036A IT202100014036A IT202100014036A1 IT 202100014036 A1 IT202100014036 A1 IT 202100014036A1 IT 102021000014036 A IT102021000014036 A IT 102021000014036A IT 202100014036 A IT202100014036 A IT 202100014036A IT 202100014036 A1 IT202100014036 A1 IT 202100014036A1
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- kit
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/82—Theaceae (Tea family), e.g. camellia
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- Health & Medical Sciences (AREA)
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- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Alternative & Traditional Medicine (AREA)
- Epidemiology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
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- Bioinformatics & Cheminformatics (AREA)
- Child & Adolescent Psychology (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Respiratory Apparatuses And Protective Means (AREA)
Description
COMPOSIZIONE O KIT PER LA PERDITA DI PESO COMPOSITION OR KIT FOR WEIGHT LOSS
La presente invenzione riguarda una composizione o un kit per la perdita di peso. In particolare la presente invenzione riguarda una composizione o un kit per la perdita di peso comprendente berberina e catechine del t? verde e suoi usi in campo medico e cosmetico. The present invention relates to a weight loss composition or kit. In particular, the present invention relates to a weight loss composition or kit comprising berberine and tea catechins. green and its uses in the medical and cosmetic fields.
? noto che l?obesit? ? una grave condizione di salute in continuo aumento nella popolazione mondiale. ? known that? obesity? ? a serious health condition that continues to increase in the world's population.
L?Organizzazione Mondiale della Sanit? (OMS) ha definito l?obesit? e il sovrappeso come ?anormali? o ?eccessivi? casi di accumulo di grasso, i quali comportano, di conseguenza, un rischio per la salute [1]. The World Health Organization? (WHO) has defined obesity? and overweight as ?abnormal? or ?excessive? cases of accumulation of fat, which consequently entail a risk to health [1].
Secondo l?OMS, nel 2016, circa 1,9 miliardi di adulti di et? pari o superiore ai 18 anni era in sovrappeso, di cui 650 milioni erano anche obesi. Nello stesso anno, nel complesso, circa il 13 % della popolazione mondiale era in sovrappeso, una situazione drammatica constatando anche come le condizioni di obesit? siano triplicate tra il 1975 ed il 2016. Inoltre si stima che, nel 2019, circa 38,2 milioni di bambini al di sotto dei 5 anni siano in una condizione di sovrappeso o obesit?. Ad aggravare questi dati si aggiunge l?aumento della prevalenza dell?obesit? nei paesi ?in via di sviluppo?, generalmente meno colpite da queste condizioni. Queste condizioni sono dovute a squilibri energetici tra calorie introdotte e calorie consumate. According to the WHO, in 2016, approximately 1.9 billion adults aged 18 years of age or older were overweight, of which 650 million were also obese. In the same year, overall, about 13% of the world's population was overweight, a dramatic situation also noting how the conditions of obesity? have tripled between 1975 and 2016. It is also estimated that, in 2019, about 38.2 million children under the age of 5 are overweight or obese. To aggravate these data is added the increase in the prevalence of obesity? in ?developing? countries, generally less affected by these conditions. These conditions are due to energy imbalances between calories introduced and calories consumed.
L?OMS ritiene che le maggiori cause dell?aumento del peso medio della popolazione mondiale siano dovute ad un maggiore apporto di cibi densi di energia ad alto contenuto di grassi e zuccheri, ad un aumento dell'inattivit? fisica dovuta alla natura sempre pi? sedentaria di molte forme di lavoro ed infine al cambiamento dei modi di trasporto e alla crescente urbanizzazione. Risulta evidente come la naturale riduzione del movimento dovuta alla recente situazione pandemica non possa che peggiorare la situazione [2]. I soggetti in gravi condizioni di sovrappeso od obesit? possono avere serie ripercussioni sulla propria salute. I maggiori rischi sono legati a malattie metaboliche, come il diabete e la dislipidemia, malattie cardiovascolari come l?infarto e l?ictus, disturbi ginecologici, predisposizione allo sviluppo di malattie dell'apparato digerente, problemi a carico delle articolazioni, infertilit?, disturbi della sfera sessuale, disturbi dell'umore, e a questo si aggiunge anche l?aumento della possibilit? di sviluppare alcuni tumori, come ad esempio il tumore endometriale, il tumore colorettale, della colecisti e della mammella [3]. Una condizione di obesit? accresce anche il pericolo dovuto al riscontro di malattie infettive, come ad esempio anche nel caso del virus SARS-CoV-2. WHO believes that the major causes of the increase in the average weight of the world's population are due to an increased intake of energy-dense foods high in fat and sugar, an increase in inactivity and physics due to nature more and more? sedentary behavior of many forms of work and finally to changing modes of transport and growing urbanisation. It is clear that the natural reduction in movement due to the recent pandemic situation can only make the situation worse [2]. Subjects in serious conditions of overweight or obesity? can have serious repercussions on your health. The greatest risks are related to metabolic diseases, such as diabetes and dyslipidemia, cardiovascular diseases such as heart attack and stroke, gynecological disorders, predisposition to the development of diseases of the digestive system, joint problems, infertility, sexual sphere, mood disorders, and to this is added the increase in the possibility to develop certain tumors, such as endometrial cancer, colorectal, gallbladder and breast cancer [3]. A condition of obesity? it also increases the danger due to the detection of infectious diseases, as for example also in the case of the SARS-CoV-2 virus.
Nel marzo del 2021, la World Obesity Federation ha pubblicato il rapporto ?COVID-19 and Obesity: The 2021 Atlas. The cost of not addressing the global obesity crisis - March 2021?. In questo documento vengono evidenziate le complicanze dovute a COVID-19 a partire da un soggetto obeso, talmente gravi che l?obesit? si dimostra un fattore predittivo di morte per COVID-19 [3]. Questa ?epidemia di obesit?? sembra non arrestarsi, anche se negli ultimi anni si stanno registrando alcuni segnali di cambiamento positivo che derivano dall?appiattimento dell?obesit? dell?infanzia [4]. In March 2021, the World Obesity Federation released the report ?COVID-19 and Obesity: The 2021 Atlas. The cost of not addressing the global obesity crisis - March 2021?. This document highlights the complications due to COVID-19 starting from an obese subject, so serious that obesity? it proves to be a predictor of death from COVID-19 [3]. This ?obesity epidemic?? does not seem to stop, even if in recent years there have been some signs of positive change deriving from the flattening out of obesity? of childhood [4].
? necessario, quindi, trovare soluzioni a questo problema. ? Therefore, it is necessary to find solutions to this problem.
Tra le varie opzioni disponibili, le linee guida per una sana alimentazione forniscono diversi approcci per il controllo del peso [5]. In caso di sovrappeso si raccomanda principalmente di ridurre le entrate caloriche ed aumentare, invece, il dispendio energetico, aumentando l?attivit? fisica. Among the various options available, the guidelines for healthy eating provide different approaches to weight management [5]. In case of overweight it is mainly recommended to reduce caloric intake and increase, instead, energy expenditure, increasing activity? physics.
Tuttavia, ? universalmente riconosciuto che la riduzione dell?apporto calorico e l?aumento dell?attivit? fisica, soprattutto in maniera significativa, sono di particolare difficolt? per la maggior parte della popolazione. However, ? universally recognized that the reduction of? caloric intake and the increase of? activity? physics, especially significantly, are of particular difficulty? for most of the population.
Inoltre, pu? essere consigliato un intervento chirurgico come strategia per controllare il peso in eccesso. Gli interventi del caso si concentrano sullo stomaco, che ? l?organo nel quale il cibo va una volta dopo essere stato ingerito. Lo stomaco inizia a digerire il cibo e lo invia quindi all?intestino che termina di digerirlo e invia i nutrienti al resto dell?organismo [6]. Conseguenzialmente, le strategie chirurgiche si sono concentrate o sulla riduzione della capienza dello stomaco, limitando il cibo ingeribile, o sulla riduzione dell?assorbimento del cibo. Gli interventi chirurgici pi? diffusi sono il BYPASS gastrico, la gastrectomia a manica ed il bendaggio gastrico regolabile. Furthermore, can Surgery may be recommended as a strategy to control excess weight. The interventions of the case focus on the stomach, which? the organ into which food once goes after being ingested. The stomach begins digesting food and then sends it to the intestines which finish digesting it and send the nutrients to the rest of the body [6]. Consequently, surgical strategies have focused either on reducing stomach capacity, limiting ingestible food, or on reducing food absorption. The most surgical interventions common are gastric BYPASS, sleeve gastrectomy and adjustable gastric banding.
Tuttavia, un intervento chirurgici rappresenta una soluzione molto drastica e riservata a una piccola percentuale dei soggetti in sovrappeso, come del resto il trattamento farmacologico. However, surgery represents a very drastic solution and is reserved for a small percentage of overweight subjects, like pharmacological treatment.
Sono, inoltre, noti diversi integratori alimentari per favorire la perdita di peso, che possono supportare ed ovviare alle difficolt? delle diete ipocaloriche o del forte incremento di attivit? fisica, e non presentano i rischi e le controindicazioni dei trattamenti farmacologici o chirurgici. In tabella 1 [7] sono indicati i maggiori ingredienti utilizzati negli integratori alimentari coadiuvanti di diete per la perdita del peso. Furthermore, several food supplements are known to promote weight loss, which can support and remedy the difficulties of weight loss. of low-calorie diets or the sharp increase in activity? physical, and do not present the risks and contraindications of pharmacological or surgical treatments. Table 1 [7] shows the main ingredients used in food supplements for weight loss diets.
Tabella 1 Table 1
Come si evince dalla tabella stessa, nessun ingrediente ha fornito per s? risultati soddisfacenti, anche se promettenti. As can be seen from the table itself, no ingredient has provided for itself? satisfactory, albeit promising, results.
Alla luce di quanto sopra, appare evidente la necessit? di fornire prodotti efficaci per la perdita di peso, in particolare per il trattamento dell?obesit?. In the light of the above, it is evident the need to provide effective weight loss products, especially for the treatment of obesity.
In questo contesto viene ad inserirsi la soluzione secondo la presente invenzione, che si propone di fornire una composizione in grado di coadiuvare una dieta ipocalorica portando efficacemente alla perdita di peso. The solution according to the present invention comes into this context, which proposes to provide a composition capable of assisting a low-calorie diet effectively leading to weight loss.
Secondo la presente invenzione ? stato ora trovato che la somministrazione di una composizione comprendente una specifica combinazione di alcuni principi attivi comporta un effetto sinergico sul metabolismo dei lipidi, sulla termogenesi e sull?assorbimento mediante meccanismi molecolari complementari, comportando un effetto consistente sulla perdita di peso. Pertanto, la composizione della presente invenzione combina dei principi attivi che agiscono congiuntamente in modo sinergico, e in maniera del tutto innovativa, per coadiuvare una dieta ipocalorica. According to the present invention ? it has now been found that the administration of a composition comprising a specific combination of some active ingredients involves a synergistic effect on lipid metabolism, thermogenesis and absorption through complementary molecular mechanisms, resulting in a consistent effect on weight loss. Therefore, the composition of the present invention combines active ingredients which jointly act in a synergistic way, and in a wholly innovative way, to assist a low-calorie diet.
Come detto sopra, la somministrazione della composizione secondo la presente invenzione comporta una perdita di peso in modo efficace, superando i limiti degli ingredienti noti utilizzati singolarmente negli integratori alimentari coadiuvanti delle diete ipocaloriche. As stated above, the administration of the composition according to the present invention effectively leads to weight loss, overcoming the limits of the known ingredients used individually in food supplements as adjuvants of low-calorie diets.
Inoltre, la presente invenzione ha il vantaggio di garantire un microbiota sano nel contesto della perdita di peso, un aspetto del tutto sottovalutato negli attuali integratori coadiuvanti della perdita di peso. Furthermore, the present invention has the advantage of guaranteeing a healthy microbiota in the context of weight loss, an aspect which is completely underestimated in current weight loss adjuvant supplements.
La composizione secondo la presente invenzione pu? essere vantaggiosamente impiegata per tutte le fasce della popolazione, anche le fasce di non-adulti, che praticano o meno sport. The composition according to the present invention can be advantageously used for all segments of the population, even non-adult segments, whether or not they practice sports.
Infine, la composizione secondo l?invenzione riconosce la necessit? di assicurare uno stato nutrizionale, per quanto riguarda vitamine e minerali, ottimale, e privo di carenze, che potrebbero compromettere la perdita di peso. Infatti, la composizione secondo la presente invenzione fornisce supporto vitaminico e minerale, ottimale per un sano dimagrimento, insieme a un ottimo mantenimento e sviluppo muscolare. Finally, the composition according to the invention recognizes the need to ensure an optimal nutritional status, with regard to vitamins and minerals, and free from deficiencies, which could compromise weight loss. In fact, the composition according to the present invention provides vitamin and mineral support, optimal for healthy weight loss, together with excellent muscle maintenance and development.
Forma pertanto oggetto specifico della presente invenzione una composizione comprendente o consistente in un estratto di pianta Berberis aristata o berberina, isolata da detta pianta o di sintesi, e un estratto di pianta Camellia sinensis, o catechine, come ad esempio epigallocatechina-3-gallato (EGCG), isolate da detta pianta o di sintesi, eventualmente assieme a uno o pi? eccipienti e/o adiuvanti. Therefore, a specific object of the present invention is a composition comprising or consisting of an extract of the Berberis aristata or berberine plant, isolated from said plant or synthesis, and an extract of the Camellia sinensis plant, or catechins, such as for example epigallocatechin-3-gallate ( EGCG), isolated from said plant or synthesis, possibly together with one or more? excipients and/or adjuvants.
Inoltre, la presente invenzione concerne un kit di parti comprendente o consistente in una prima composizione comprendente un estratto di pianta Berberis aristata o berberina, isolata da detta pianta o di sintesi, eventualmente assieme a uno o pi? eccipienti e/o adiuvanti, e una seconda composizione comprendente un estratto di pianta Camellia sinensis, o catechine, come ad esempio epigallocatechina-3-gallato (EGCG), isolate da detta pianta o di sintesi, eventualmente assieme a uno o pi? eccipienti e/o adiuvanti. Furthermore, the present invention relates to a kit of parts comprising or consisting of a first composition comprising an extract of the Berberis aristata or berberine plant, isolated from said plant or synthesized, optionally together with one or more? excipients and/or adjuvants, and a second composition comprising an extract of Camellia sinensis plant, or catechins, such as for example epigallocatechin-3-gallate (EGCG), isolated from said plant or synthesis, optionally together with one or more? excipients and/or adjuvants.
L?importanza della berberina ? dovuta alla sua influenza sui livelli dei lipidi nel sangue, ma anche sul microbiota intestinale, sulla regolazione genica, sulla permeabilit? intestinale e sulla gluconeogenesi epatica. Secondo (2020)[8], l?obesit? ? da sempre legata ad alti livelli lipidici ed al metabolismo stesso dei lipidi che sono il core della sindrome metabolica. L?assunzione di berberina in quantit? di circa 100-200 mg al giorno, mediante la composizione secondo la presente invenzione, permette di ottenere un?azione efficace sul metabolismo dei lipidi. The importance of berberine? due to its influence on blood lipid levels, but also on the intestinal microbiota, gene regulation, permeability and intestinal and hepatic gluconeogenesis. According to (2020)[8], obesity? ? always linked to high lipid levels and to the metabolism of lipids itself which are the core of the metabolic syndrome. The intake of berberine in quantity? of about 100-200 mg per day, by means of the composition according to the present invention, it allows to obtain an effective action on the lipid metabolism.
Secondo la presente invenzione, l?estratto di Berberis aristata o il principio attivo berberina pu? essere incapsulato in modo tale da mascherare il sapore spiacevole di detto estratto o principio attivo. According to the present invention, the extract of Berberis aristata or the active ingredient berberine can be encapsulated in such a way as to mask the unpleasant taste of said extract or active ingredient.
La pianta Camellia sinensis ? anche detta Camellia sinensis (L.) Kuntze e, secondo una particolare forma di realizzazione, ci si riferisce a un estratto di C. sinensis Kuntze comprendente il 95% di epigallocatechina gallato (EGCG). The Camellia sinensis plant? also called Camellia sinensis (L.) Kuntze and, according to a particular embodiment, it refers to an extract of C. sinensis Kuntze comprising 95% epigallocatechin gallate (EGCG).
I componenti attivi del t? verde associati alla perdita di peso sono la caffeina e le catechine, principalmente il flavonoide epigallocatechina gallato. La caffeina ? una metilxantina [9] che stimola il sistema nervoso centrale, il cuore e i muscoli scheletrici. Questa molecola ? in grado di favorire in maniera dose-dipendente la termogenesi. Diversi studi, inoltre, indicano un possibile ruolo della caffeina nella perdita di peso. Infatti, essa favorirebbe l'ossidazione dei grassi attraverso la stimolazione del sistema nervoso centrale [7]. L?Epigallocatechina-3-gallato (EGCG) ? la pi? abbondante catechina presente nel t? verde e favorisce la riduzione del tessuto adiposo. I meccanismi di azione ipotizzati sono diversi. Le maggiori ipotesi si riferiscono all?attivazione dell?AMPK nel fegato, nei muscoli scheletrici e nel tessuto adiposo [10], o ad un ruolo nella modulazione genetica [11,12,13]. Secondo la composizione della presente invenzione, le catechine del t? verde, in particolare EGCG, agiscono in sinergia con la berberina per agire sulla termogenesi. La dose di t? verde consigliata ? di circa 100-200 mg al giorno. The active components of tea green associated with weight loss are caffeine and catechins, mainly the flavonoid epigallocatechin gallate. The caffeine ? a methylxanthine [9] which stimulates the central nervous system, heart and skeletal muscles. This molecule? capable of promoting thermogenesis in a dose-dependent manner. Several studies also point to a possible role of caffeine in weight loss. In fact, it would favor the oxidation of fats by stimulating the central nervous system [7]. Epigallocatechin-3-gallate (EGCG) ? the "P? abundant catechin present in tea green and promotes the reduction of adipose tissue. The hypothesized mechanisms of action are different. The major hypotheses refer to the activation of AMPK in the liver, skeletal muscle and adipose tissue [10], or to a role in genetic modulation [11,12,13]. According to the composition of the present invention, the tea catechins green, in particular EGCG, act in synergy with berberine to act on thermogenesis. The dose of tea? recommended green? about 100-200 mg per day.
Secondo la presente invenzione, detto estratto di pianta Camellia sinensis pu? comprendere una percentuale di catechine del 65% rispetto al peso dell?estratto. According to the present invention, said Camellia sinensis plant extract can include a percentage of catechins of 65% with respect to the weight of the extract.
In particolare, nella composizione o kit secondo la presente invenzione detto estratto di pianta Berberis aristata pu? essere presente in una percentuale pari a 1,4%, ad esempio 1,428571%, in peso della composizione finale da somministrare; mentre detto estratto di pianta Camellia sinensis pu? essere presente in una percentuale pari a 1,4%, ad esempio 1,428571%, in peso della composizione finale da somministrare. Perr composizione finale da somministrare si intende la composizione come definita sopra oppure la composizione ottenuta mescolando la prima composizione e la seconda composizione del kit come definito sopra. In particular, in the composition or kit according to the present invention said Berberis aristata plant extract can be present in a percentage equal to 1.4%, for example 1.428571%, by weight of the final composition to be administered; while said Camellia sinensis plant extract can? be present in a percentage equal to 1.4%, for example 1.428571%, by weight of the final composition to be administered. By final composition to be administered is meant the composition as defined above or the composition obtained by mixing the first composition and the second composition of the kit as defined above.
Inoltre, secondo la presente invenzione dette catechine possono essere presenti in una percentuale pari a 0,9%, ad esempio 0,928571%, in peso della composizione finale da somministrare, in cui la composizione finale da somministrare ? definita sopra. Secondo una ulteriore forma di realizzazione, nella composizione o nel kit secondo la presente invenzione detta composizione o detta prima composizione e/o seconda composizione di detto kit possono comprendere ulteriormente glucomannano e/o farina di semi di Guar. Furthermore, according to the present invention said catechins can be present in a percentage equal to 0.9%, for example 0.928571%, by weight of the final composition to be administered, wherein the final composition to be administered is ? defined above. According to a further embodiment, in the composition or in the kit according to the present invention said composition or said first composition and/or second composition of said kit can further comprise glucomannan and/or guar seed flour.
L?autorit? europea di sicurezza alimentare (EFSA) [18] ha dato parere positivo a riguardo dell?efficacia del glucomannano (sostenendo che ?Il glucomannano contribuisce a mantenere stabili livelli di colesterolo nel sangue? e che ?Il glucomannano contribuisce a perdere peso nel contesto di una dieta ipocalorica?). La quantit? consigliata ? di almeno 500 mg al giorno. Secondo la presente invenzione, gli effetti del glucomannano sono decisamente aumentati quando utilizzato in combinazione con i principi attivi della composizione secondo la presente invenzione, ossia berberina e catechine del t? verde. The authority European Food Safety Authority (EFSA) [18] has given a positive opinion on the efficacy of glucomannan (arguing that ?Glucomannan helps to maintain stable blood cholesterol levels? and that ?Glucomannan helps to lose weight in the context of a low-calorie diet?). The quantity? recommended ? of at least 500 mg per day. According to the present invention, the effects of glucomannan are markedly increased when used in combination with the active ingredients of the composition according to the present invention, namely berberine and tea catechins. green.
Per quanto concerne, la farina di semi di Guar, l?EFSA [14] ha riconosciuto che ?la gomma di guar contribuisce a mantenere stabili livelli di colesterolo nel sangue?. La quantit? consigliata ? di almeno 1 g. La farina di semi di Guar agisce, pertanto, sul metabolismo del sangue con un meccanismo d?azione diverso da quello della berberina, aumentando, dunque, l?efficacia del prodotto. As far as Guar seed flour is concerned, EFSA [14] has recognized that ?guar gum helps to maintain stable blood cholesterol levels?. The quantity? recommended ? of at least 1 g. Guar seed flour therefore acts on blood metabolism with a mechanism of action different from that of berberine, thus increasing the effectiveness of the product.
In particolare, secondo la presente invenzione, il glucomannano pu? essere presente in una percentuale del 7 %, ad esempio 7,143%, in peso della composizione finale da somministrare, mentre la farina di semi di Guar pu? essere presente in una percentuale del 14 %, ad esempio 14,286%, in peso della composizione finale da somministrare, in cui la composizione finale da somministrare ? definita sopra. In particular, according to the present invention, glucomannan can be present in a percentage of 7%, for example 7.143%, by weight of the final composition to be administered, while the Guar seed flour can? be present in a percentage of 14%, for example 14.286%, by weight of the final composition to be administered, wherein the final composition to be administered is defined above.
Inoltre, detta composizione o detta prima composizione e/o seconda composizione di detto kit possono comprendere ulteriormente uno, pi? di uno o tutti i seguenti ingredienti: gomma arabica, fruttooligosaccaridi, arabinogalattano, lecitina di soia, policosanoli, ad esempio octacosanolo, vitamine come vitamina C, vitamina B1, vitamina B2, vitamina B6, acido pantotenico, niacina, D-biotina, vitamina B12, vitamina D, vitamina E, vitamina A, acido folico, minerali come calcio, in particolare calcio carbonato 40%, zinco, in particolare zinco gluconato, cromo picolinato, selenio, in particolare seleno metionina. Furthermore, said composition or said first composition and/or second composition of said kit can further comprise one, more? of one or all of the following ingredients: gum arabic, fructooligosaccharides, arabinogalactan, soy lecithin, policosanols, e.g. octacosanol, vitamins such as vitamin C, vitamin B1, vitamin B2, vitamin B6, pantothenic acid, niacin, D-biotin, vitamin B12 , vitamin D, vitamin E, vitamin A, folic acid, minerals such as calcium, especially calcium carbonate 40%, zinc, especially zinc gluconate, chromium picolinate, selenium, especially selenomethionine.
La gomma arabica, come la gomma arabica Kordofan (polvere), ? nota per le sue forti capacit? nella riduzione della lipogenesi. Gli studi finora condotti mostrano il successo dell?utilizzo della gomma arabica nella modulazione del tessuto adiposo e del peso in pazienti sovrappeso, obesi o diabetici [15,16,17]. La quantit? consigliata ? di almeno 500 mg al giorno. Il meccanismo di azione sulla lipogenesi della gomma arabica ? diverso da quello degli altri ingredienti nell?invenzione. Gum arabic, such as Kordofan gum arabic (powder), is known for her strong skills in the reduction of lipogenesis. The studies conducted so far show the success of the use of gum arabic in the modulation of adipose tissue and weight in overweight, obese or diabetic patients [15,16,17]. The quantity? recommended ? of at least 500 mg per day. The mechanism of action on gum arabic lipogenesis? different from that of the other ingredients in the invention.
I frutto-oligosaccaridi (FOS) hanno un importante ruolo nella crescita della microflora intestinale non patogena. Il loro consumo aumenta il bolo fecale e la frequenza delle deposizioni. Una dose di 4-15 g/ giorno somministrata a soggetti sani riduce la stitichezza [19,20]. Un buon funzionamento dell?intestino e una microflora intestinale sana sono ritenuti di grande importanza per la perdita di peso. La quantit? consigliata ? di almeno 1 g di FOS. Fructo-oligosaccharides (FOS) play an important role in the growth of non-pathogenic intestinal microflora. Their consumption increases the faecal bolus and the frequency of deposition. A dose of 4-15 g/day administered to healthy subjects reduces constipation [19,20]. A well-functioning intestine and a healthy intestinal microflora are considered to be of great importance for weight loss. The quantity? recommended ? of at least 1 g of FOS.
L'arabinogalattano ? una fibra che fermenta nell'intestino. Questo ingrediente sembra aumentare i batteri intestinali (es. Lactobacillus) e avere altri effetti benefici riguardanti il tratto digerente [21,22]. Un buon funzionamento dell?intestino e una microflora intestinale sana sono ritenuti di grande importanza per la perdita di peso. La quantit? consigliata ? di almeno 500 mg. The arabinogalactan? a fiber that ferments in the intestines. This ingredient appears to increase intestinal bacteria (e.g. Lactobacillus) and have other beneficial effects regarding the digestive tract [21,22]. A well-functioning intestine and a healthy intestinal microflora are considered to be of great importance for weight loss. The quantity? recommended ? of at least 500 mg.
Per quanto concerne la lecitina di soia, studi clinici evidenziano possibili effetti sulla riduzione del colesterolo LDL e sull?aumento del colesterolo HDL [23]. In particolare si evidenzia come la lecitina potrebbe modificare l'omeostasi del colesterolo nel fegato, aumentando l'attivit? dell'HMG-CoA reduttasi e della colesterolo 7 alfa-idrossilasi, diminuendo l'attivit? microsomiale dell'ACAT [24]. Si tratta di un meccanismo diverso ed ulteriore rispetto a quelli attuali. La quantit? consigliata ? di almeno 490 mg. As far as soy lecithin is concerned, clinical studies show possible effects on the reduction of LDL cholesterol and on the increase of HDL cholesterol [23]. In particular, it highlights how lecithin could modify the homeostasis of cholesterol in the liver, increasing the activity of HMG-CoA reductase and cholesterol 7 alpha-hydroxylase, decreasing the activity microsomal of ACAT [24]. It is a different and additional mechanism compared to the current ones. The quantity? recommended ? of at least 490 mg.
I policosanoli, in particolare policosanoli comprendenti il 60% di octacosanolo, hanno un?efficacia dimostrata nella riduzione del colesterolo LDL e nel miglioramento del profilo lipidico [25,26]. Essi agiscono in maniera diversa dalle altre sostanze. La quantit? consigliata ? di almeno 8 mg. Policosanols, in particular policosanols comprising 60% octacosanol, have demonstrated efficacy in reducing LDL cholesterol and improving the lipid profile [25,26]. They act differently from other substances. The quantity? recommended ? of at least 8 mg.
Inoltre, la composizione secondo la presente invenzione pu? contenere tutte le vitamine necessarie per coadiuvare una dieta per la perdita del peso. Furthermore, the composition according to the present invention can contain all the vitamins needed to assist a weight loss diet.
In particolare, la vitamina ?C? protetta (acido ascorbico protetto o ascorbile palmitato), la vitamina B1 (Tiamina cloridrato), la vitamina B2 (riboflavina), la vitamina B6 (piridossina cloridrato), l?acido pantotenico (calcio pantotenato), la nicotinamide (niacina), la D-biotina e la vitamina B12 (cianocobalamina) contribuiscono al mantenimento del corretto metabolismo energetico [27]. Tale effetto ? stato riconosciuto dall?EFSA. Si assicura, dunque, il normale fisiologico metabolismo energetico. Pertanto, la presenza di vitamine ? preferibile nella composizione secondo l?invenzione. La quantit? minima ? del 15 % del valore nutritivo di riferimento. In particular, vitamin ?C? protected (protected ascorbic acid or ascorbyl palmitate), vitamin B1 (thiamine hydrochloride), vitamin B2 (riboflavin), vitamin B6 (pyridoxine hydrochloride), pantothenic acid (calcium pantothenate), nicotinamide (niacin), D -biotin and vitamin B12 (cyanocobalamin) contribute to the maintenance of correct energy metabolism [27]. Such an effect? been recognized by EFSA. Therefore, the normal physiological energy metabolism is ensured. Therefore, the presence of vitamins ? preferable in the composition according to the invention. The quantity? minimal ? 15% of the nutrient reference value.
Inoltre, la presenza di Acido folico (Acido pteroilmonoglutammico) e Vitamina D (colecalciferolo) contribuisce al mantenimento muscolare, necessario a sostenere un programma di attivit? fisica e mantenendo il sistema immunitario [28,29,30,31,32,27]. La quantit? minima ? del 15 % del valore nutritivo di riferimento. Pertanto, la presenza di questi composti nella composizione secondo la presente invenzione ? preferita al fine di favorire il dimagrimento e il completamento del programma di dimagrimento. Furthermore, the presence of folic acid (pteroylmonoglutamic acid) and Vitamin D (cholecalciferol) contributes to muscle maintenance, necessary to support a program of active activities. physical fitness and maintaining the immune system [28,29,30,31,32,27]. The quantity? minimal ? 15% of the nutrient reference value. Therefore, the presence of these compounds in the composition according to the present invention ? preferred in order to promote weight loss and the completion of the weight loss program.
La vitamina ?E? (DL-alfa-tocoferolo acetato) agisce, invece, nel metabolismo del glucosio ed ? stato evidenziato come i suoi effetti siano dose-dipendenti [33]. La quantit? minima ? del 15 % del valore nutritivo di riferimento. Vitamin ?E? (DL-alpha-tocopherol acetate) acts, however, in the metabolism of glucose and ? its effects have been shown to be dose-dependent [33]. The quantity? minimal ? 15% of the nutrient reference value.
Infine, l?utilizzo della vitamina ?A? (retinile acetato) ? legato al ruolo dei suoi metaboliti, retinaldeide e acido retinoico, nel metabolismo lipidico [34,35,36]. La quantit? minima ? del 15 % del valore nutritivo di riferimento. Finally, the use of vitamin ?A? (retinyl acetate) ? related to the role of its metabolites, retinaldehyde and retinoic acid, in lipid metabolism [34,35,36]. The quantity? minimal ? 15% of the nutrient reference value.
La presenza di minerali, come ad esempio calcio e zinco, favorisce il corretto mantenimento e sviluppo muscolare, che sono indispensabili per sostenere un programma di attivit? fisica. The presence of minerals, such as calcium and zinc, promotes proper muscle maintenance and development, which are essential to support an activity program. physics.
In particolare, il cromo picolinato agisce controllando i livelli glicemici, ed insieme al selenio rafforza il risultato di una dieta per la perdita del peso [37,38,39,40]. La quantit? minima ? del 15 % del valore nutritivo di riferimento. Secondo la presente invenzione la composizione pu? comprendere ulteriormente uno, pi? di uno o tutti i seguenti ingredienti: maltodestrine, sucralosio, acido citrico, betacarotene, biossido di silicio, aromi, come ad esempio aroma di arancia. In particular, chromium picolinate acts by controlling blood sugar levels, and together with selenium strengthens the result of a weight loss diet [37,38,39,40]. The quantity? minimal ? 15% of the nutrient reference value. According to the present invention the composition can further understand one, more? of any or all of the following: maltodextrin, sucralose, citric acid, beta-carotene, silicon dioxide, flavorings, such as orange flavoring.
Secondo la presente invenzione, detta composizione o detta prima composizione e/o seconda composizione di detto kit possono essere preparate in forma di polvere, di bevanda liquida, di capsule, di compresse o di caramelle. According to the present invention, said composition or said first composition and/or second composition of said kit can be prepared in the form of a powder, liquid drink, capsule, tablet or candy.
In particolare, quando la composizione secondo la presente invenzione ? in forma di in forma di capsule, detta composizione pu? comprendere i principi attivi in una capsula di gelatina animale e/o vegetale, opzionalmente con l?aggiunta di agenti di carica, come ad esempio la cellulosa, e/o di antiaggreganti, come ad esempio il biossido di silicio. In particular, when is the composition according to the present invention ? in the form of in the form of capsules, said composition pu? comprise the active ingredients in an animal and/or vegetable gelatin capsule, optionally with the addition of bulking agents, such as for example cellulose, and/or antiplatelet agents, such as silicon dioxide for example.
Quando la composizione secondo la presente invenzione ? in forma di compresse, detta composizione pu? comprendere agenti di rivestimento, come ad esempio idrossi propil multicellulosa e/o gomma lacca, pu? comprendere agenti di carica, come ad esempio cellulosa microcristallina, e pu? comprendere eventuali aromi, come ad esempio fragola, banana o altro, e/o coloranti. When is the composition according to the present invention ? in the form of tablets, this composition pu? include coating agents, such as hydroxy propyl multicellulose and/or shellac, can? include bulking agents, such as microcrystalline cellulose, and can? include any flavourings, such as strawberry, banana or other, and/or colourings.
Quando la composizione secondo la presente invenzione ? in forma di polvere, detta composizione pu? essere inserita in bustine comprendenti succo d'arancia o di limone in polvere, correttori di acidit?, come l?E334 e/o l?E330, un eventuale agente antiagglomerante come il biossido di silicio, zuccheri od edulcoranti, e/o aromi naturali. When is the composition according to the present invention ? in powder form, this composition can? be placed in sachets containing powdered orange or lemon juice, acidity regulators, such as E334 and/or E330, any anti-caking agent such as silicon dioxide, sugars or sweeteners, and/or natural flavourings.
Inoltre, la composizione secondo la presente invenzione pu? essere miscelata con un liquido per ottenere una bevanda, ad esempio bevande con dosatori. In tal caso, la composizione secondo l?invenzione pu? essere miscelata con acqua, maltodestrine, acidificanti, come l?acido citrico, antiossidanti, come l?acido ascorbico, aromi naturali, e/o edulcoranti, preferilbilmente il sucralosio e/o l?acesulfame K. Furthermore, the composition according to the present invention can be mixed with a liquid to obtain a drink, for example drinks with dispensers. In this case, the composition according to the invention can be mixed with water, maltodextrins, acids, such as citric acid, antioxidants, such as ascorbic acid, natural flavors, and/or sweeteners, preferably sucralose and/or acesulfame K.
Quando la composizione secondo la presente invenzione ? in forma di caramelle, la composizione pu? comprendere ulteriormente zucchero, ad esempio zucchero di canna, oppure sciroppo di glucosio; pectina; acido citrico; succo di frutta; e/o aromi naturali. In tal caso la composizione secondo la presente invenzione sarebbe in forma di caramelle morbide. La composizione o detta prima composizione e/o seconda composizione di detto kit possono essere un integratore alimentare. When is the composition according to the present invention ? in the form of candy, the composition can? further comprise sugar, for example cane sugar, or glucose syrup; pectin; citric acid; fruit juice; and/or natural flavors. In this case the composition according to the present invention would be in the form of soft candies. The composition or said first composition and/or second composition of said kit can be a food supplement.
Inoltre, la presente invenzione concerne, la composizione o kit come definito sopra per l?uso nel trattamento dell?obesit?. Furthermore, the present invention relates to the composition or kit as defined above for use in the treatment of obesity.
La composizione finale secondo la presente invenzione per l?uso nell?obesit? pu? essere somministrata in una quantit? da 7 a 14 grammi, preferibilmente 14 grammi al giorno, in cui per composizione finale da somministrare si intende la composizione come definita nella rivendicazione 1 oppure la composizione ottenuta mescolando la prima composizione e la seconda composizione del kit come definito nella rivendicazione 2. The final composition according to the present invention for use in obesity? can? be administered in a quantity? from 7 to 14 grams, preferably 14 grams per day, wherein by final composition to be administered is meant the composition as defined in claim 1 or the composition obtained by mixing the first composition and the second composition of the kit as defined in claim 2.
Secondo la presente invenzione detta prima composizione e seconda composizione di detto kit possono essere somministrate in modo separato o sequenziale. According to the present invention said first composition and second composition of said kit can be administered separately or sequentially.
Per somministrazione in modo ?separato? si intende la somministrazione, nello stesso momento, dei due composti del kit secondo l?invenzione in forme farmaceutiche distinte. Per somministrazione in modo ?sequenziale? si intende la somministrazione successiva dei due composti del kit secondo l?invenzione, ciascuno in una forma farmaceutica distinta. For administration in a ?separate? it means the administration, at the same time, of the two compounds of the kit according to the invention in distinct pharmaceutical forms. For administration in a ?sequential? it means the successive administration of the two compounds of the kit according to the invention, each in a distinct pharmaceutical form.
Costituisce ulteriore oggetto della presente invenzione anche l?uso cosmetico (o non terapeutico) di una composizione o di un kit come definiti sopra per la perdita di peso, in soggetti non affetti da obesit?. A further object of the present invention is also the cosmetic (or non-therapeutic) use of a composition or kit as defined above for weight loss, in subjects not affected by obesity.
Secondo la presente invenzione, la composizione finale da somministrare per l?uso cosmetico pu? essere somministrata in una quantit? da 7 a 14 grammi, preferibilmente 14 grammi al giorno, in cui per composizione finale da somministrare si intende la composizione come definita nella rivendicazione 1 oppure la composizione ottenuta mescolando la prima composizione e la seconda composizione del kit come definito nella rivendicazione 2. According to the present invention, the final composition to be administered for cosmetic use can be administered in a quantity? from 7 to 14 grams, preferably 14 grams per day, wherein by final composition to be administered is meant the composition as defined in claim 1 or the composition obtained by mixing the first composition and the second composition of the kit as defined in claim 2.
Quando si impiega il kit secondo la presente invenzione, detta prima composizione e seconda composizione di detto kit possono essere somministrate in modo separato o sequenziale. When using the kit according to the present invention, said first composition and second composition of said kit can be administered separately or sequentially.
Per somministrazione in modo ?separato? si intende la somministrazione, nello stesso momento, dei due composti del kit secondo l?invenzione in forme farmaceutiche distinte. Per somministrazione in modo ?sequenziale? si intende la somministrazione successiva dei due composti del kit secondo l?invenzione, ciascuno in una forma farmaceutica distinta. For administration in a ?separate? it means the administration, at the same time, of the two compounds of the kit according to the invention in distinct pharmaceutical forms. For administration in a ?sequential? it means the successive administration of the two compounds of the kit according to the invention, each in a distinct pharmaceutical form.
La presente invenzione verr? ora descritta, a titolo illustrativo, ma non limitativo, secondo una sua forma preferita di realizzazione, con particolare riferimento all?esempio sotto riportato. This invention will come now described, for illustrative but not limiting purposes, according to a preferred embodiment thereof, with particular reference to the example shown below.
ESEMPIO 1: Composizione secondo la presente invenzione (EX XL FAST SLIM). EXAMPLE 1: Composition according to the present invention (EX XL FAST SLIM).
In Tabella 2 ? riportato un esempio di composizione secondo la presente invenzione, in particolare una composizione in polvere. La tabella di riferisce a una bustina da 7 g da solubilizzare in acqua o altri liquidi adatti (circa 250 ml). In Table 2 ? an example of a composition according to the present invention is reported, in particular a composition in powder form. The table refers to a 7 g sachet to be dissolved in water or other suitable liquids (about 250 ml).
Tabella 2 Table 2
Secondo la presente invenzione la dose giornaliera consigliata ? di due bustine al giorno, ciascuna da assumere prima dei pasti principali (circa 15 minuti prima del pasto). According to the present invention the recommended daily dose ? of two sachets a day, each to be taken before main meals (about 15 minutes before a meal).
La presente invenzione ? stata descritta a titolo illustrativo, ma non limitativo, secondo sue forme preferite di realizzazione, ma ? da intendersi che variazioni e/o modifiche potranno essere apportate dagli esperti nel ramo senza per questo uscire dal relativo ambito di protezione, come definito dalle rivendicazioni allegate. The present invention ? been described for illustrative, but non-limiting purposes, according to preferred embodiments thereof, but ? it should be understood that variations and/or modifications may be made by experts in the art without thereby departing from the relative scope of protection, as defined by the attached claims.
Claims (10)
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