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      A decade of nutraceutical patents: where are we now in 2018?

      1 , 1 , 1
      Expert Opinion on Therapeutic Patents
      Informa UK Limited

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          Abstract

          In the last 10 years, nutraceuticals have grown in interest to researchers, industry, and consumers and are now familiar in the collective imagination as a tool for preventing the onset of a disease. Often nutraceuticals are confused with biologically active phytochemicals/botanicals which can have health benefits. This is a misunderstanding however as the term nutraceutical refers to a product that must have a beneficial effect on health proven by clinical testing. Areas covered: A search has been performed on both recent patents and the literature regarding nutraceuticals focusing on the beneficial and proven health effects on pathological conditions to give an overview of the state-of-the-art developments in this area. Patents and literature data addressing specific pathological conditions are discussed. Expert opinion: Nutraceuticals represent a challenge for the future of drug-based pharmacotherapy, and, at the same time, are a powerful tool for the prevention of chronic disease. They are not proposed as an alternative to drugs, but instead, can be helpful to complement a pharmacological therapy and prevent the onset of chronic diseases in subjects who do not qualify for conventional pharmacological treatment.

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          Most cited references54

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          Efficacy of berberine in patients with type 2 diabetes mellitus.

          Berberine has been shown to regulate glucose and lipid metabolism in vitro and in vivo. This pilot study was to determine the efficacy and safety of berberine in the treatment of type 2 diabetes mellitus patients. In study A, 36 adults with newly diagnosed type 2 diabetes mellitus were randomly assigned to treatment with berberine or metformin (0.5 g 3 times a day) in a 3-month trial. The hypoglycemic effect of berberine was similar to that of metformin. Significant decreases in hemoglobin A1c (from 9.5%+/-0.5% to 7.5%+/-0.4%, P<.01), fasting blood glucose (from 10.6+/-0.9 mmol/L to 6.9+/-0.5 mmol/L, P<.01), postprandial blood glucose (from 19.8+/-1.7 to 11.1+/-0.9 mmol/L, P<.01), and plasma triglycerides (from 1.13+/-0.13 to 0.89+/-0.03 mmol/L, P<.05) were observed in the berberine group. In study B, 48 adults with poorly controlled type 2 diabetes mellitus were treated supplemented with berberine in a 3-month trial. Berberine acted by lowering fasting blood glucose and postprandial blood glucose from 1 week to the end of the trial. Hemoglobin A1c decreased from 8.1%+/-0.2% to 7.3%+/-0.3% (P<.001). Fasting plasma insulin and homeostasis model assessment of insulin resistance index were reduced by 28.1% and 44.7% (P<.001), respectively. Total cholesterol and low-density lipoprotein cholesterol were decreased significantly as well. During the trial, 20 (34.5%) patients experienced transient gastrointestinal adverse effects. Functional liver or kidney damages were not observed for all patients. In conclusion, this pilot study indicates that berberine is a potent oral hypoglycemic agent with beneficial effects on lipid metabolism.
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            Role of nutraceuticals in human health.

            Nutraceutical is the hybrid of 'nutrition' and 'pharmaceutical'. Nutraceuticals, in broad, are food or part of food playing a significant role in modifying and maintaining normal physiological function that maintains healthy human beings. The principal reasons for the growth of the nutraceutical market worldwide are the current population and the health trends. The food products used as nutraceuticals can be categorized as dietary fibre, prebiotics, probiotics, polyunsaturated fatty acids, antioxidants and other different types of herbal/ natural foods. These nutraceuticals help in combating some of the major health problems of the century such as obesity, cardiovascular diseases, cancer, osteoporosis, arthritis, diabetes, cholesterol etc. In whole, 'nutraceutical' has lead to the new era of medicine and health, in which the food industry has become a research oriented sector.
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              Nutraceuticals: opening the debate for a regulatory framework

              Currently, nutraceuticals do not have a specific definition distinct from those of other food‐derived categories, such as food supplements, herbal products, pre‐ and probiotics, functional foods, and fortified foods. Many studies have led to an understanding of the potential mechanisms of action of pharmaceutically active components contained in food that may improve health and reduce the risk of pathological conditions while enhancing overall well‐being. Nevertheless, there is a lack of clear information and, often, the claimed health benefits may not be properly substantiated by safety and efficacy information or in vitro and in vivo data, which can induce false expectations and miss the target for a product to be effective, as claimed. An officially shared and accepted definition of nutraceuticals is still missing, as nutraceuticals are mostly referred to as pharma‐foods, a powerful toolbox to be used beyond the diet but before the drugs to prevent and treat pathological conditions, such as in subjects who may not yet be eligible for conventional pharmaceutical therapy. Hence, it is of utmost importance to have a proper and unequivocal definition of nutraceuticals and shared regulations. It also seems wise to assess the safety, mechanism of action and efficacy of nutraceuticals with clinical data. A growing demand exists for nutraceuticals, which seem to reside in the grey area between pharmaceuticals and food. Nonetheless, given specific legislation from different countries, nutraceuticals are experiencing challenges with safety and health claim substantiation.
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                Author and article information

                Journal
                Expert Opinion on Therapeutic Patents
                Expert Opinion on Therapeutic Patents
                Informa UK Limited
                1354-3776
                1744-7674
                November 22 2018
                December 02 2018
                November 29 2018
                December 02 2018
                : 28
                : 12
                : 875-882
                Affiliations
                [1 ] Department of Pharmacy, University of Napoli Federico II, Napoli, Italy
                Article
                10.1080/13543776.2018.1552260
                30484340
                1782a7e3-3029-4152-82d7-46dd008b468e
                © 2018
                History

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