• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Composition comprising aloe gel and hydroxytyrosol. Pharmaceutical or nutraceutical composition comprising between 90-99.9% of aloe gel powder and 0.1% -10% of Hydroxytyrosol; characterized in that the aloe gel powder does not contain aloin. Use of the composition for the manufacture of a medicament for the treatment and/or prevention of metabolic syndrome and type II diabetes and as a food supplement. (Machine-translation by Google Translate, not legally binding)
    公开号:ES2734600A1
    申请号:ES201830454
    申请日:2018-05-08
    公开日:2019-12-10
    发明作者:ARCHE Mª ANGELES FERNÁNDEZ；GIMENEZ Mª DOLORES GARCÍA；La Puerta Vázquez Rocio De；Martín María Angel；GUERREO ANA Mª QUÍLEZ；Martínez José Miguel Zapata
    申请人:Universidad de Sevilla；Universidad de Alcala de Henares UAH；
    IPC主号:
    专利说明:

    [0001]
    [0002] Aloe and hydroxytyrosol gel composition
    [0003]
    [0004] The present invention relates to a pharmaceutical and nutracetic composition comprising aloe gel and hydroxytyrosol (HT). In addition, the invention relates to the use of said composition as a dietary dietary supplement for the control of glycemic index and cholesterol; and for the preparation of a medicament for the treatment and / or prevention of the disease of metabolic syndrome and type II diabetes.
    [0005]
    [0006] Thus, the present invention can be framed in the pharmaceutical and food field, as well as in the nutraceutical, phytotherapy, and medicinal plants sector.
    [0007]
    [0008] BACKGROUND OF THE INVENTION
    [0009]
    [0010] Obesity is the most prevalent metabolic disease in developed countries. There is a direct relationship between the degree of obesity and morbidity and mortality, as it increases the risk of suffering from other diseases such as type 2 diabetes mellitus, dyslipidemia, arterial hypertension etc. All of them, in turn, are risk factors for cardiovascular disease, which is currently the leading cause of death in the world (Cuatrecasa G., Foz M. and Formiguera X. Obesity and its comorbidities. SPECIAL JANE 2002; 62 (1418): 57-8).
    [0011]
    [0012] According to data from the National Statistics Institute (INE), in the last 20 years the obesity rate has tripled in developed countries and constitutes more than 30% of the population in some European countries. Approximately 50% of adults in Europe are overweight. To the health problem, the economic cost generated by the treatments of the multiple pathologies associated with obesity is added. In Spain, this expense reaches 7% of health expenditure and between 2 and 6% of the total cost of health in other developed countries (Gutierrez-Fisac JL Obesity Epidemiology. SPECIAL JANO 2002; 62 (1418): 37- 46).
    [0013]
    [0014] Pharmacological treatment against obesity is only indicated in patients with a Body Mass Index (BMI) greater than or equal to 30kg / m2 or in patients with a BMI greater than 27kg / m2, with other associated diseases such as type 2 diabetes or dyslipidemia. And it is only justified if it is accompanied by changes in lifestyle, including hypocaloric diet and exercise. The drugs that are currently indicated for obesity are not effective enough and have significant adverse effects. Many of them have had to be removed after a very short time of commercialization. Another alternative is bariatric surgery, but it also includes a high risk to the patient's life as well as a high economic cost.
    [0015]
    [0016] Faced with this situation, there is a growing interest in the use of plants and their derivatives, appearing as a crucial strategy to help control obesity and overweight.
    [0017]
    [0018] Currently in the market there are numerous preparations with natural ingredients, plants or derivatives thereof that are used to control overweight. Its use is justified in most cases, either by producing satiety; Its components are generally polysaccharide in nature, for example: Fucus vesiculosus algal brown algae, or vegetable fiber; in other cases the mechanism is based on increasing lipolysis / thermogenesis, as is the case with green tea, or its derivatives such as caffeine or Garcinia cambodgia; others interfere with the digestion of nutrients, mainly fat, as is the case with plants, whose components act as inhibitors of pancreatic lipase.
    [0019]
    [0020] One of the plant species, which in recent years has been the subject of numerous studies related to the problem of obesity, is Aloe Vera. Its properties on the skin were already well known, but in the last 5 years its use has been extended, orally with various indications, including weight loss. Recent research work on animals has shown metabolic effects in both animals and humans (Ramesh Pothuraju; Raj kumar Sharma; Suneel Kumar Onteru; Satvinder Singh and Shaik Abdul Hussain. Hypoglglycemic and HYpolipidemic effects of Aloe vera Extract Preparations: A review. Phytother Res 2015.DOI: 10.1002 / ptr.5532). There are different mechanisms of action involved, which could justify its effectiveness on the control of overweight and associated syndromes such as hyperglycemia and hyperlipidemia. Another mechanism that could be involved is related to the effect on the intestinal microbiota. The microbiota plays a very important role in the control of obesity. In fact, This flora is altered in obese people. One of the major components of the Aloe leaf is acemannan, a polysaccharide, not degradable by digestive enzymes, but it is fermentable by intestinal microflora bacteria, giving rise to short-chain fatty acids (propionate, butyrate and acetate) that can act on different receptors of the intestinal wall, activating different pathways, that finally stimulate the decrease of adiposity (Yagi A .; Nakamori J.; Yamad T. et al. In vivo metabolism of aloemanan. Planta Med. 1999; 65 : 417-420). Products marketed to date that comprise derivatives of Aloe vera do not guarantee the absence of aloin, a compound present in the sheet with stimulant-type laxative action that can limit its safety of use.
    [0021]
    [0022] On the other hand, Hydroxytyrosol (HT), is the majority polyphenol in virgin olive oil and is also found in the leaves and fruit. A phenolic compound obtained exclusively by physical methods and one of the most potent natural antioxidants, being responsible, to a large extent, for much of the healthy effects of virgin olive oil. It has been shown to possess numerous properties as an anti-inflammatory, antithrombotic, antimicrobial and anti-aging agent. In relation to obesity, studies published recently, on the effects of HT on adipogenesis, lipolysis and glucose consumption in 3T3-L1 adipocyte cultures, indicate that this polyphenol has the capacity to modulate numerous signaling pathways that affect its pathogenesis and other associated risk factors (Drida R; Chen S; Sakamoto K. Oleuropein and hydroxytyrosol inhibit adipocyte differentiation in 3T3-L1 cells. Life Sci. 2011; 89, 708-716). For example, its ability to contribute to the protection of blood lipids, preventing the oxidation of LDL lipoproteins, responsible for the initiation of atherogenic processes, property that has been recognized by the European Food Safety Agency (EFSA) for the declaration of health.
    [0023]
    [0024] Therefore, it would be desirable to have a more effective and stable pharmaceutical and food composition, which also does not produce side effects produced by aloe vera aloin and with antioxidant properties such as those provided by hydroxytyrosol.
    [0025] DESCRIPTION OF THE INVENTION
    [0026] In a first aspect, the present invention relates to a composition comprising the following ranges of components expressed in percentage by weight with respect to the total composition:
    [0027] 90-99.9% aloe gel powder; Y
    [0028] 0.1-10% hydroxytyrosol.
    [0029] characterized in that the aloe gel powder does not contain aloin.
    [0030]
    [0031] Another aspect of the present invention relates to the use of the composition defined above for the manufacture of a medicament.
    [0032]
    [0033] In another embodiment the invention relates to the use defined above, for the manufacture of a medicament administered orally.
    [0034]
    [0035] In another embodiment the invention relates to the use defined above, for the manufacture of a medicament administered in a dose of 200 or 400 mg / kg / day of aloe gel powder and 0.15 mg / kg / day of hydroxytyrosol.
    [0036]
    [0037] In another embodiment the invention relates to the use defined above, for the manufacture of a medicament administered:
    [0038] orally; Y
    [0039] In a dose of 200 or 400 mg / kg / day of aloe gel powder and 0.15 mg / kg / day of hydroxytyrosol.
    [0040]
    [0041] Another aspect of the present invention relates to the use of the composition defined above for the manufacture of a medicament for the treatment and / or prevention of metabolic syndrome and type II diabetes.
    [0042]
    [0043] In another embodiment the invention relates to the composition defined above for use in the treatment and / or prevention of metabolic syndrome and type II diabetes administered orally.
    [0044]
    [0045] In another embodiment the invention relates to the use of the composition defined above for the manufacture of a medicament for the treatment and / or prevention of metabolic syndrome and type II diabetes administered in a dose of 200 or 400 mg / kg / day of powder of aloe gel and 0.15 mg / kg / day of hydroxytyrosol.
    [0046] In another embodiment the invention relates to the use of the composition defined above for the manufacture of a medicament for the treatment and / or prevention of metabolic syndrome and type II diabetes administered:
    [0047] orally; and in a dose of 200 or 400 mg / kg / day of aloe gel powder and 0.15 mg / kg / day of hydroxytyrosol.
    [0048]
    [0049] Another aspect of the present invention relates to the use of the composition defined above as a food supplement, and preferably as a dietary food supplement to reduce body weight, blood glucose levels and cholesterol levels.
    [0050]
    [0051] In another embodiment the invention relates to the use of the composition defined above as a food supplement, and preferably as a dietary food supplement to reduce body weight, blood glucose levels and cholesterol levels, administered orally.
    [0052]
    [0053] In another embodiment the invention relates to the use of the composition defined above as a food supplement, and preferably as a dietary food supplement to reduce body weight, blood glucose levels and cholesterol levels, administered in a dose of 200 or 400 mg / Kg / day of aloe gel powder and 0.15 mg / Kg / day of hydroxytyrosol.
    [0054]
    [0055] In another embodiment the invention relates to the use of the composition defined above as a food supplement, and preferably as a dietary food supplement to reduce body weight, blood glucose levels and cholesterol levels, administered:
    [0056] orally; Y
    [0057] in a dose of 200 or 400 mg / kg / day of aloe gel powder and 0.15 mg / kg / day of hydroxytyrosol.
    [0058]
    [0059] Another aspect of the present invention relates to the use of the composition defined above, as a food ingredient.
    [0060]
    [0061] Aloe gel is a product of great biological value, highly demanded in the currently for its applications in the food, cosmetic and pharmaceutical industry. In its composition, the polysaccharides of the mucilage type (pectins, hemicellulose, glucomannan, acemananos), bioactive compounds, which by their physical characteristics, trap water molecules, leading to an increase in volume in the digestive tract and producing a feeling of satiety, stand out. Trials, both in animals and in humans, have demonstrated the ability of Aloe gel to improve metabolic dysfunctions associated with obesity, although research on its exact mechanism of action is scarce.
    [0062]
    [0063] Thus, the pharmaceutical and nutracetic composition of the invention has the advantage that it guarantees the safety of its use by reducing its side effects by not containing aloin. The aloe of the composition of the invention comes from the central parenchyma of the leaf of the aloe vera plant that contains mostly water and polysaccharide components, being guaranteed after processing the absolute use of aloin. The aloe gel of the invention is useful for reducing body weight and improving the metabolic dysfunctions associated with obesity such as the elevation of glucose and / or cholesterol.
    [0064]
    [0065] The orally administered aloe gel is capable of inducing satiety, moderately reducing appetite and weight gain, as well as improving plasma glucose and cholesterol values. These properties are due to the fact that its composition is rich in mucilage-like polysaccharides.
    [0066]
    [0067] The association of the aloe gel powder of the invention with an antioxidant such as hydroxytyrosol (HT) produces a synergistic effect by increasing the effectiveness of the aloe gel both in weight reduction and in the reduction of glycemia and cholesterolemia with respect to the use of Aloe gel in the absence of hydroxytyrosol. In addition, hydroxytyrosol helps maintain the stability of the composition and preserve the properties of the final product.
    [0068]
    [0069] HT is a phenolic compound specific to the olive tree, which has potent antioxidant properties and is responsible for much of the healthy effects of virgin olive oil. It has been shown to possess numerous properties as an anti-inflammatory, antithrombotic, antimicrobial and anti-aging agent. In relation to obesity, it has been shown that HT has the capacity to modulate numerous signaling pathways in adipogenesis, lipolysis and glucose consumption in 3T3-L1 adipocyte cultures, indicating that this polyphenol has the capacity to modulate numerous signaling pathways that affect its pathogenesis and other associated risk factors.
    [0070]
    [0071] HT acts by preventing the oxidation of blood lipids, thus reducing cardiovascular risk. It also decreases the proliferation of pre-adipocytes and their differentiation and increases lipolysis.
    [0072]
    [0073] This invention is based on the results obtained in experiments carried out on animals, which have been induced to gain weight through a high fat diet, while these diet has been supplemented with this association (Aloe HT), observing that after daily administration, over 8 weeks, weight gain is prevented and plasma cholesterol and glucose levels in animals are reduced, compared to the untreated group.
    [0074]
    [0075] Comparative tests have been performed to show that the effect of aloe gel is increased when supplemented with HT. Through these tests it has also been observed that the antioxidant effect of HT increases the stability of the composition.
    [0076]
    [0077] Based on the results obtained in animal experimentation, the most effective daily dose of this product is: 200mg of aloe gel and 0.15mg of hydroxytyrosol per kilo of body weight and day. As can be seen in Figure 1, similar results were obtained with doses of 200 and 400mg / kg against the prevention of weight gain. However, the 200mg / Kg / day was more effective with regard to the regulation of glycemia and hypercholesterolemia.
    [0078]
    [0079] This product could be administered in different ways, preferably orally and in the indicated daily doses.
    [0080]
    [0081] The composition can be prepared in sachets containing aloe gel powder and hydroxytyrosol in the appropriate proportion (for example, 200mg aloe gel + 0.15mg of HT / Kg), to resuspend it in a liter of water and be administered along a day.
    [0082] Continued consumption of this preparation over weeks, will reduce weight gain, due to the satiating power of aloe gel and will help reduce blood glucose and cholesterol levels, such effects being enhanced, by the presence of Hydroxytyrosol.
    [0083]
    [0084] The composition of the invention can be supplied together as an ingredient of another food or as a supplement in the indicated doses. Where said food is consumed according to the indicated doses, for example, daily. Examples of foods include, among others, biscuit, snack, whole wheat bread, cereal bar and yogurt.
    [0085]
    [0086] In the present invention, the effect of oral administration of aloe gel and aloe gel supplemented with HT on the intake, weight gain and plasma glucose and cholesterol levels in animals fed with a diet high in fat and inducing diabetes Melitus type 2.
    [0087]
    [0088] Throughout the description and the claims the word "comprises" and its variants are not intended to exclude other technical characteristics, additives, components or steps. For those skilled in the art, other objects, advantages and features of the invention will be derived partly from the description and partly from the practice of the invention. The following examples and figures are provided by way of illustration, and are not intended to be limiting of the present invention.
    [0089]
    [0090] BRIEF DESCRIPTION OF THE FIGURES
    [0091]
    [0092] FIG. 1 Shows the variation of the weight of the animals throughout the 8 weeks of experimentation. Grupol: animals fed with a standard diet; Group 2: Animals fed a high fat diet (DAG); Group 3: DAG-fed animals supplemented with ALOE HT (200mg + 0.15mg / kg / day); Group 4: animals fed with DAG supplemented with ALOE HT (400mg + 0.15mg / kg / day); Group 5: DAG-fed animals supplemented with ALOE (400mg / kg / day).
    [0093]
    [0094] FIG. 2 Shows the measurement of total cholesterol in animal sera. Group1: animals fed with a standard diet; Group 2: Animals fed a high fat diet (DAG); Group 3: DAG-fed animals supplemented with ALOE HT (200mg + 0.15mg / kg / day); Group 4: animals fed with DAG supplemented with ALOE HT (400mg + 0.15mg / kg / day); Group 5: DAG-fed animals supplemented with ALOE (400mg / kg / day). Each value represents the mean ± SEM of three triplicate experiments. Statistical test: ANOVA Dunnett (* p <0.5; *** p <0.001 versus control group).
    [0095]
    [0096] FIG. 3 Shows the plasma glucose values of the animals: Group 1: animals fed with a standard diet; Group 2: Animals fed a diet high in a (DAG); Group 3: DAG-fed animals supplemented with ALOE HT (200mg 0.15mg / kg / day); Group 4: Animals fed with DAG supplemented with ALOE HT (400mg 0.15mg / kg / day); Group 5: Animals fed with DAG supplemented with ALOE (400mg / kg / day). Each value represents the mean ± SEM of three triplicate experiments. Statistical test: ANOVA Dunnett (* p <0.5; *** p <0.001versus control group).
    [0097]
    [0098] EXAMPLES
    [0099]
    [0100] The invention will now be illustrated by tests carried out by the inventors, which demonstrates the effectiveness of the product of the invention.
    [0101]
    [0102] Characteristics of the tested products :
    [0103] • Aloe Vera gel powder , supplied by Veracetics company. Freeze-dried Aloe vera powder, from the internal parenchyma of the leaves. White color. 100% NATURAL. Two doses of Aloe gel powder were used: 200mg / Kg / day and 400mg / Kg / day.
    [0104] • Hydroxytyrosol supplied by the Biomaslinic company. With 40% purity. It was used at a dose of 0.15mg / Kg / day, (values extrapolated to animals, according to recommendations of the European Food Safety Agency (EFSA)
    [0105]
    [0106] Animals and diets :
    [0107] The experimental animals used were mice of the strain C57Bl / 6 males, 6 weeks old, which were supplied by the Animal Production and Experimentation Center of the University of Seville. They were kept at a temperature of 24-25 ° C and twelve hours of daylight. The use of animals throughout the This study was carried out according to the norms established by the Ethical Committee of the University of Seville. Two different doses of aloe gel were tested (200mg / Kg and 400mg / Kg and day). Aloe gel was also tested without supplementation with HT in order to compare the effect of supplementation with this phenol.
    [0108]
    [0109] Experimental protocol:
    [0110] After a week of acclimatization, in which the animals received a standard diet, they were randomly divided into 6 groups of 10 and received the following diets and treatments for 8 weeks:
    [0111]
    [0112] - Standard diet group (1): Received a standard diet during the entire treatment period (DS).
    [0113]
    [0114] -Group high fat diet: received a high fat diet, during the entire treatment period (DAG).
    [0115]
    [0116] -Low dose group of Aloe HT (2): received the high-fat diet, supplemented with Aloe gel powder (200mg / kg / day) and hydroxytyrosol (0.15mg / Kg / day) (DAG-Aloe-HT200)
    [0117] -High dose group of Aloe HT (3): received the high-fat diet, supplemented with Aloe gel powder (400mg / kg / day) and hydroxytyrosol (4) (0.15mg / Kg / day) (DAG-Aloe -HT400).
    [0118]
    [0119] -High dose group of Aloe without HT (5): received the high-fat diet supplemented with Aloe gel powder (400mg / kg / day) (DAG-Aloe).
    [0120]
    [0121] In the high-fat diet (used to induce obesity) 42% of the total calorie comes from lipids, compared to 13% provided by the standard diet. Both diets were supplied by Harlam (Barcelona, Spain).
    [0122]
    [0123] Parameters evaluated
    [0124]
    [0125] Intake and weight control
    [0126] The weight of the animals was monitored weekly as well as the food intake per animal. At the end of the treatment period, the animals were slaughtered.
    [0127] Obtaining samples (serum)
    [0128] After the 8-week period of experimentation, the animals were sedated to proceed with the extraction of blood by cardiac puncture. The blood was processed to obtain serum by centrifugation (800G, for 15 minutes at 4 ° C) and stored at -80 ° C for later analysis.
    [0129]
    [0130] Evaluation of blood parameters:
    [0131] Determination of mg / dL of glucose and serum cholesterol, of all the samples obtained, through the use of commercial kits.
    [0132]
    [0133] Results
    [0134]
    [0135] Control of animal intake and weight throughout treatment
    [0136] The animals in the control group (treated with the standard diet) were the ones that ingested the most feed. Its lower fat content makes it less satiating so they need a higher intake. In the rest of the groups fed the high-fat diet and the different supplements, a very similar intake profile is observed, with no significant difference between the groups.
    [0137]
    [0138] Regarding the effect on variations in weight (Figure 1), it was observed that the batch fed with the standard diet was the one that increased the least weight, despite being the group that ingested the most grams of feed. Group 2, (fed the high-fat and untreated diet), was the one that most increased body weight. Groups 3 and 4, fed with the high-fat diet but treated with Aloe HT were the ones that gained less weight compared to the group supplemented only with Aloe gel, which experienced a slightly smaller weight gain than the group fed with a high-diet diet. fat (DAG). This result demonstrates how aloe gel (alone) has a very moderate effect against groups that have HT supplementation.
    [0139]
    [0140] Measurement of total plasma cholesterol values
    [0141] Of the groups treated with the different supplements, we observe that group 3 (DAG + Aloe200 + HT) is the one that managed to reduce cholesterol levels significantly. The reduction induced by the rest of the groups being more moderate.
    [0142] Measurement of plasma glucose values
    [0143] As in the previous parameter we found that group 3 treated with the 200mg dose of Aloe HT, again shows a significant reduction in blood glucose levels compared to the group fed the high-fat diet. In the same way as in the previous measure, the rest of the groups showed a very moderate effect.
    [0144]
    [0145] In all the parameters evaluated, it was observed that the high fat diet used was able to increase: weight, total cholesterol values and plasma glucose values, thus confirming the effectiveness of the model used.
    [0146]
    [0147] Statistical analysis of the results
    [0148] All trials were performed in triplicate. Statistical analysis was performed with the GraphPad Prism software, using an analysis of variance (ANOVA), followed by the Dunett test. The difference between the values obtained was considered significant from p <0.05.
    权利要求:
    Claims (9)
    [1]
    1. Composition comprising the following components expressed in percentage by weight with respect to the total composition:
    90-99.9% aloe gel powder; Y
    0.1-10% hydroxytyrosol.
    characterized in that the aloe gel powder does not contain aloin.
    [2]
    2. Use of the composition according to claim 1 for the manufacture of a medicament.
    [3]
    3. Use of the composition according to claim 1, for the manufacture of a medicament for the treatment and / or prevention of metabolic syndrome and type II diabetes.
    [4]
    4. Use of the composition according to claim 1 as a food supplement.
    [5]
    5. The use according to claim 4, as a dietary dietary supplement to reduce body weight, blood glucose levels and cholesterol levels.
    [6]
    6. Use of the composition according to claim 1, as a food ingredient.
    [7]
    7. The use according to any of claims 2 to 6, characterized in that the composition is administered orally.
    [8]
    8. The use according to any of claims 2 to 7, characterized in that the composition is administered in a dose of 200 or 400 mg / kg / day of aloe gel powder.
    [9]
    9. The use according to any of claims 2 to 8, characterized in that the composition is administered in a dose of 0.15 mg / kg / day of hydroxytyrosol.
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    同族专利:
    公开号 | 公开日
    ES2734600B2|2020-04-14|
    WO2019215370A1|2019-11-14|
    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    JP2003286185A|2002-03-29|2003-10-07|Daily Foods Kk|Squeezed liquid of aloe vera and hypoglycemic agent containing the squeezed liquid as effective ingredient|
    WO2005007114A2|2003-07-14|2005-01-27|Creagri, Inc.|Method of treating diabetes type ii|
    JP2006149354A|2004-11-26|2006-06-15|Harue Miyagi|Health tea for diabetes|
    WO2014038962A1|2012-09-05|2014-03-13|Apimed Medical Honey Limited|Methods and uses of an extract from olive leaf in management of type 2 diabetes|
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    PCT/ES2019/070306| WO2019215370A1|2018-05-08|2019-05-08|Composition of aloe gel and hydroxytyrosol|
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