Effects of bioactive compounds from Pleurotus mushrooms on COVID-19 risk factors associated with the cardiovascular system / 中西医结合学报

Mushrooms are a group of fungi with great diversity and ultra-accelerated metabolism. As a consequence, mushrooms have developed a protective mechanism consisting of high concentrations of antioxidants such as selenium, polyphenols, β-glucans, ergothioneine, various vitamins and other bioactive metabolites. The mushrooms of the Pleurotus genus have generated scientific interest due to their therapeutic properties, especially related to risk factors connected to the severity of coronavirus disease 2019 (COVID-19). In this report, we highlight the therapeutic properties of Pleurotus mushrooms that may be associated with a reduction in the severity of COVID-19: antihypertensive, antihyperlipidemic, antiatherogenic, anticholesterolemic, antioxidant, anti-inflammatory and antihyperglycemic properties. These properties may interact significantly with risk factors for COVID-19 severity, and the therapeutic potential of these mushrooms for the treatment or prevention of this disease is evident. Besides this, studies show that regular consumption of Pleurotus species mushrooms or components isolated from their tissues is beneficial for immune health. Pleurotus species mushrooms may have a role in the prevention or treatment of infectious diseases either as food supplements or as sources for pharmacological agents.

Risk Assessment of Coumarin Intake in the Norwegian Population

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has at the request of the Norwegian Food Safety Authority (Mattilsynet) conducted a risk assessment of the coumarin intake in the Norwegian population. VKM was asked to assess if any part of the population has a total intake of coumarin that will exceed the tolerable daily intake (TDI). It should further be considered whether an intake of coumarin exceeding TDI 1-2 times a week for several years would represent a risk to the health of the consumer. The assessment has been performed by the VKM Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics (Panel 4). Coumarin is a naturally flavouring substance in cinnamon and occurs in many plants. The substance can be found in different types of cinnamon to a varying degree. The two main types are Ceylon (Cinnamomum zeylandicum) and Cassia cinnamon (Cinnamomum aromaticum). Cassia cinnamon, which currently is most frequently used in food products on the Norwegian market, contains more coumarin than the lesser used Ceylon cinnamon. Oral intake of coumarin is mostly related to consumption of cinnamon-containing foods or cinnamon as a spice. This includes both direct addition of cinnamon to foods as well as the use of cinnamon oils and other cinnamon extracts by the food industry. Other important sources of exposure could be food supplements based on cinnamon or the use of cosmetic products through dermal exposure, as synthetic coumarin is added as a fragrance ingredient to perfumes, skin gels, lotions and deodorants. It is known from animal experiments that coumarin can cause liver toxicity. It is considered as a non-genotoxic carcinogen in mice and rats. In 2004, the European Food Safety Authority (EFSA) established a TDI of 0.1 mg coumarin/kg body weight (bw), based on a no observed adverse effect level (NOAEL) for liver toxicity in a 2-year dog study. This TDI was maintained when the substance was re-evaluated in 2008. EFSA further concluded that exposure to coumarin resulting in an intake 3 times higher than the TDI for 1-2 weeks was not of safety concern. In order to answer the second question as stated in the terms of reference, the VKM Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food and Cosmetics found it necessary to further examine the data on toxicity of coumarin, which were the basis for the TDI established by EFSA. The most significant hazards of coumarin appears to be liver toxicity, which is well documented, and demonstrated in mice, rats, dogs, baboons and humans, and kidney adenomas in male rats. In a review of human case reports, a small subgroup of the human population appears for unknown reasons to be more susceptible to medical treatment with coumarin. The lowest reported dose of coumarin associated with liver toxicity in humans is around 0.4 mg/kg bw/day. It should be noted that the liver toxicity of coumarin in humans usually is reversible. Since there were no dose-response data for humans, animal data were used in the hazard characterisation. The VKM Panel decided to use the benchmark dose (BMD) approach to determine a point of departure for adverse effects of coumarin. The 2-year chronic toxicity/carcinogenicity study in rats by the US National Toxicology Program (NTP) was chosen for model simulation and BMD/BMDL (benchmark dose lower confidence limit) calculations. The best model fit of the dose-response data combined with the lowest BMDL05 (dose where the response is likely to be smaller than 5%) was seen for increased relative liver weight in female rats, which gave a BMDL05 of 7 mg/kg bw/day (converted from 10 mg/kg bw, 5 times per week). The VKM Panel used the BMDL05 for relative increase in liver weight in female rats to establish a TDI of 0.07 mg/kg bw/day using an uncertainty factor of 100 to account for interand intraspecies variation. The intake calculations for coumarin from food and drinks in this opinion are based on both data from the nationally representative food consumption surveys Norkost, Ungkost, Småbarnskost and Spedkost, as well as on assumed worst intake scenarios of different cinnamon-containing food products. The average coumarin levels found in cinnamoncontaining food categories such as ginger bread, cinnamon buns and similar bakery products, cinnamon-containing cakes, thin pastry with cinnamon and cinnamon-based tea sold on the Norwegian market, were used to calculate the total coumarin intake in different age groups in the population. For the calculation of the coumarin intake from cinnamon powder sprinkled on oatmeal porridge and rice porridge, a coumarin level of 3000 mg/kg in cinnamon powder was used. The frequency of consumption and the amount of cinnamon powder (from ¼ - 1 teaspoon) sprinkled on the porridge were taken into account in the calculations. To assess if any part of the Norwegian population has an intake of coumarin that will exceed the TDI, the different intake scenarios presented in the opinion have been compared with the TDI of 0.07 mg/kg bw/day established by VKM. The main conclusions from the VKM Panel were: The total estimated intake of coumarin for mean and high consumers of cinnamon-containing foods are below the TDI for all age groups when consumption of cinnamon-based tea and porridge with cinnamon was excluded. Children and adults who regularly consume oatmeal porridge sprinkled with cinnamon may exceed the TDI by several folds depending on the frequency of consumption and the amount of cinnamon used. Small children (1- and 2-years old) who have a mean or high consumption of oatmeal porridge may exceed the TDI even if they use moderate amounts of cinnamon powder on the porridge. In a worst case scenario with high consumption of porridge and use of high amounts of cinnamon powder, the estimated coumarin intake could exceed the TDI by about 20-fold. This intake is similar to dose levels of coumarin used in medical treatment of adults and where cases of liver toxicity have been reported. Drinking of cinnamon-based tea, which may have a high content of coumarin, can also result in a total intake of coumarin that exceeds the TDI both for children and adults. Other relevant sources of coumarin are cosmetics and food supplements with cinnamon. The recommended dose of two cinnamon supplements sold on the Norwegian market can lead to an exceedance of TDI in adults. It is not anticipated that children will consume supplements with cinnamon. Cosmetic products (shower gels, body lotions, deodorants and oils) are important sources of coumarin exposure both for children and adults, but quantification of the coumarin exposure from cosmetics was not possible due to lack of data. The VKM Panel concludes that based on the available data, the possibility of an adverse health effect by exceeding the TDI 3-fold for 1-2 times per week for several years cannot be assessed. Generally, a minor or an occasional exceedance of TDI is not considered to increase the risk of adverse health effects. The coumarin intake could exceed the TDI by 7-20 fold in some instances. Liver toxicity may occur shortly after the start of coumarin exposure. Such large daily exceedances of TDI, even for a limited time period of 1-2 weeks, cause concern of adverse health effects.

Perfil hídrico e consumo de suplementos por frequentadores de academias / Water profile and consumption of supplements by academics / Perfil hídrico y consumo de suplementos por frecuentadores de gimnasios

Objetivo: avaliar o perfil hídrico e o consumo de suplementos de pessoas fisicamente ativas inseridas em academias da cidade Montes Claros, Minas Gerais, Brasil. Método: Trata-se de estudo transversal, realizado com praticantes de atividade física, em 2018. Participaram da pesquisa 200 pessoas, maiores de 20 anos, de ambos os sexos, frequentadores de academias. Realizou-se a avaliação nutricional dos participantes, com aplicação de questionário estruturado, contendo questões relacionadas à prática de atividade física, ingestão hídrica e uso de suplementos alimentares. Resultados: dentre os participantes, 52,5% era do sexo feminino e 65% estavam com peso adequado. Verificou-se que a 71% da população estuda consumia mais que dois litros de água por dia. Dentre os praticantes de atividade física, 60,5% e 99% não faziam o uso de suplementos e anabolizantes, respectivamente. Além disso, 96% não utilizavam ergogênicos. Conclusão: este estudo demonstrou que a população estudada possui ingestão adequada de água e baixo consumo de suplementos, anabolizantes e ergogênicos.(AU)

Objective: to evaluate the water profile and the consumption of supplements by physically active people inserted in academies of the city of Montes Claros, Minas Gerais, Brazil. Method: This is a cross-sectional study, carried out with physical activity practitioners in 2018. The study included 200 people, over 20 years old, of both sexes, attending academies. The nutritional evaluation of the participants was carried out with the application of a structured questionnaire containing questions related to the practice of physical activity, water intake and use of dietary supplements. Results: among the participants, 52.5% were female and 47.5% male. Among all respondents, 65% had normal weight. It was found that 71% of the study population consumed more than two liters of water per day. Among practitioners of physical activity, 60.5% and 99% were not using supplements and steroids, respectively. In addition, 96% of the participants did not use ergogenics. Conclusion: this study demonstrated that the population had adequate water intake and low intake of supplements, steroids and ergogenics.(AU)

Objetivo: evaluar el perfil hídrico y el consumo de suplementos de personas físicamente activas insertadas en gimnasios de la ciudad Montes Claros, Minas Gerais, Brasil. Método: Se trata de un estudio transversal, realizado con practicantes de actividad física, en 2018. Participaron de la investigación 200 personas, mayores de 20 años, de ambos sexos, frecuentadores de gimnasios. Se realizó la evaluación nutricional de los participantes, con aplicación de cuestionario estructurado, conteniendo cuestiones relacionadas a la práctica de actividad física, ingestión hídrica y uso de suplementos alimenticios. Resultados: de los participantes, el 52,5% era del sexo femenino y el 47,5% del sexo masculino. Entre todos los entrevistados, el 65% estaba con peso adecuado. Se verificó que el 71% de la población estudia consumía más de dos litros de agua al día. Entre los practicantes de actividad física, el 60,5% y el 99% no hacían el uso de suplementos y anabolizantes, respectivamente. Además, el 96% de los estudiados no utilizaba ergogénicos. Conclusión: este estudio demostró que la población estudiada posee ingestión adecuada de agua y bajo consumo de suplementos, anabolizantes y ergogénicos.(AU)

Assessment of Dietary Intake of Vitamin K and Maximum Limits for Vitamin K in Food Supplements

The Norwegian Scientific Committee for Food and Environment (Vitenskapskomiteen for mat og miljø, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet; NFSA), evaluated the intake of vitamin K in the diet. VKM has also assessed the consequences of establishing maximum limits for vitamin K in food supplements at 100, 200, 300, 600 or 800 µg/day. The former maximum limit for vitamin K of 200 µg/day in food supplements was repealed 30 May 2017. Vitamin K is a fat-soluble vitamin required for the carboxylation of glutamic acid residues in proteins that regulate blood coagulation and bone metabolism. The naturally occurring forms of vitamin K present in food and supplements are phylloquinone (vitamin K1) mainly produced by plants, and a range of menaquinones (vitamin K2) mainly produced by bacteria. The chemical structure of vitamin K is characterised by a methylated naphtoquinone ring structure assumed to be responsible for its function, in addition to a side chain which differs in length and degree of saturation. Due to the varying side chains, the different forms of vitamin K are thought to behave differently with regard to absorption, metabolism, bioavailability and thereby also toxic potential. Dark green leafy vegetables are rich sources of phylloquinone. Meat and liver products provide menaquinone-4, the most common menaquinone in Western diets, while other menaquinones are found in fermented foods and cheese. An Adequate Intake (AI) of phylloquinone of 1 µg/kg body weight per day was set by the Scientific Committee on Food (SCF) in 1993 and maintained by the European Food Safety Authority (EFSA) in 2017. No dietary reference values (DRVs) have been established for menaquinones due to insufficient evidence. Furthermore, no tolerable upper intake levels (ULs) have been established for any form of vitamin K due to insufficient evidence, but previous reports stated that no adverse effects associated with vitamin K consumption from food or supplements had been reported in humans or animals. In 2003, the UK Expert Group on Vitamins and Minerals (EVM) proposed a guidance level (GL) for safe upper intake of supplemental phylloquinone of 1 mg/day in adults. The GL was set by applying an uncertainty factor of 10 for inter-individual variation to the supplemental dose of 10 mg/day that had been consumed by eight female athletes (age 20-44) for 30 days with no reported adverse effects. The UK expert group emphasised that GLs had been derived from limited data and were less secure than safe upper levels. This GL was supported by a double-blind randomised study cited in the Nordic Nutrition Recommendations (2012), in which 440 postmenopausal women with osteopenia received a daily supplement of 5 mg phylloquinone or placebo for up to four years with no difference in adverse events between the randomised groups. Corresponding GLs for children and adolescents have been derived by adjusting for reference body weights0.75 by Rasmussen et al. (2006). The distribution of intakes of vitamin K across age groups in Norway is not known, since food composition data is not available. However, habitual intakes in a representative sample of middle-aged and older adults in Western Norway were assessed in the population-based Hordaland Health Study 1997-2000, and revealed higher intakes than those estimated from dietary surveys in the other Nordic countries. Due to lack of representative estimates of vitamin K intakes in the Norwegian population, information on vitamin K intakes from other Nordic countries is included in the current opinion. This includes the distribution of vitamin K intakes in Sweden and Finland reported by EFSA, and the distribution of vitamin K intakes in Denmark, assessed by the Technical University of Denmark (DTU). In middle-aged and older Western Norwegians participating in the Hordaland Health Study 1997-2000, estimated mean intakes of total vitamin K (denoting the sum of K1+K2) ranged from 109 to 148 µg/day in four groups based on age and gender, while the 95-percentiles ranged from 261 to 329 µg/day. Average intakes of total vitamin K in the other Nordic countries are in the magnitude of 100 µg/day in adults, while 95-percentiles in adults are in the magnitude of 200 µg/day. To illustrate the consequences of establishing maximum limits for vitamin K at 100, 200, 300, 600 or 800 µg/day in food supplements, VKM has compared these levels to the age-specific GLs for supplemental phylloquinone proposed by EVM (2003). The GLs are: 1000 µg/day for adults, 870 µg/day at age 15-17 years, 670 µg/day at age 11-14 years, 500 µg/day at age 710 years, 370 µg/day at age 4-6 years and 270 µg/day at age 1-3 years. VKM concludes that: In adults and adolescents 15-17 years old, maximum limits of 100, 200, 300, 600 and 800 µg/day are below GL. In adolescents 11-14 years old, maximum limits of 100, 200, 300 and 600 µg/day are below GL while the maximum limit of 800 µg exceeds GL. In children 4-10 years old, maximum limits of 100, 200 and 300 µg/day are below GL while maximum limits of 600 µg/day and 800 µg/day exceeds GL. In children 1-3 years old, maximum limits of 100 µg/day and 200 µg/day are below GL while maximum limits of 300, 600 and 800 µg/day exceeds GL. VKM notes that the current conclusions apply to phylloquinone (vitamin K1) only, while there is insufficient evidence to appraise potential health consequences of maximum limits of menaquinones (vitamin K2). VKM emphasises that the current assessment of maximum limits for vitamin K in food supplements is merely based on published reports concerning upper levels from the IOM (2001, USA), SCF (2003, EU), EVM (2003, UK) and NNR (2012, Nordic countries). VKM has not conducted any systematic review of the literature for the current opinion, as this was outside the scope of the terms of reference from NFSA.

Risk Assessment of "Other Substances" – Inulin

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet, NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods. "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional or ph ysiological effect. It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects. The present report is a risk assessment of inulin, and it is based on previous risk assessments and articles retrieved from a literature search. According to information from NFSA, inulin is an ingredient in food supplements sold in Norway. NSFA has requested a risk assessment of the dose 3 g/day of inulin in food supplements. The total exposure to inulin from other sources than food supplements and cosmetics, such as foods, is not included in the risk assessment. Inulin is a naturally occurring carbohydrate found in a variety of vegetables and fruits such as onions, leeks, garlic, asparagus, artichokes, bananas and wheat. Chicory root is the most common source of industrially produced inulin. Inulin belongs to the nondigestible polysaccharides which are carbohydrates that resist digestion in the small intestine but are fermented by bacteria in the colon. No serious adverse health effects were identified in the human studies included in this opinion. The reported negative health effects of inulin-type fibres are generally mild gastrointestinal symptoms and include diarrhea, abdominal rumbling, bloating, cramping and excessive flatulence. Such effects occur over a wide range of doses and may also depend on the source of inulin. Chain length influences the negative gastrointestinal effects, which will be less with long-chained inulin molecules. As a pragmatic approach, the intake of 5 g/day of inulin from agave and Jerusalem artichoke and 10 g/day of inulin from chicory root and globe artichoke were chosen as the values for comparison with the exposure to inulin from food supplements in the risk characterization. These doses were without serious adverse health effects, even though mild gastrointestinal effects may occur in some/sensitive individuals. These doses are in the same range as the estimated average consumption of inulin from food in Europe (3 – 11 g/day). Data indicates that also doses up to 20 g/day may be well tolerated by most people. However, there is a wide interpersonal variability in the doses at which gastrointestinal effects associated with the colonic fermentation will appear. No studies on children (10 to <14 years) and adolescents (14 to <18 years) were identified. Based on the included literature there was no evidence indicating that age affects tolerance for inulin. Therefore, in this risk assessment the same tolerance as for adults was assumed for these age groups (adjusted for body weight). From a daily dose of 3 g inulin, the calculated intake levels are 69.1, 48.9 and 42.9 mg/kg bw per day for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively. In the risk characterisation, the values used for comparisons with the exposure from food supplements is 5 g/day of inulin from agave and Jerusalem artichoke and 10 g/day of inulin from chicory root and globe artichoke (corresponding to 71 and 143 mg/kg bw per day, respectively, in a 70 kg adult). Comparing the exposure of a daily dose of 3 g/day of inulin from food supplements with the inulin doses of 5 g/day and 10 g/day considered to be without appreciable risk for most healthy adults, it is unlikely that this dose in food supplements causes any adverse health effects in children above 10 years, adolescents and adults. VKM concludes that it is unlikely that a daily dose of 3 g of inulin from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Risk Assessment of "Other Substances" – Piperine

The Norwegian Scientific Committee for Food Safety (Vitenskapskomiteen for mattrygghet, VKM) has, at the request of the Norwegian Food Safety Authority (Mattilsynet, NFSA), assessed the risk of "other substances" in food supplements and energy drinks sold in Norway. VKM has assessed the risk of doses given by NFSA. These risk assessments will provide NFSA with the scientific basis while regulating the addition of “other substances” to food supplements and other foods. "Other substances" are described in the food supplement directive 2002/46/EC as substances other than vitamins or minerals that have a nutritional or physiological effect . It is added mainly to food supplements, but also to energy drinks and other foods. In this series of risk assessments of "other substances", VKM has not evaluated any claimed beneficial effects from these substances, only possible adverse effects. The present report is a risk assessment of piperine, and it is based on previous risk assessments and articles retrieved from a literature search. According to information from NFSA, piperine, derived from black pepper, is an ingredient in food supplements sold in Norway. NFSA has requested a risk assessment of the dose 1.5 mg/day of piperine in food supplements. The total exposure to piperine from other sources than food supplements, such as foods or cosmetics, is not included in the risk assessment. Piperine (( E , E )-piperine) is a naturally occurring alkaloid which is the major pungent compound found in spices like black pepper ( Piper nigrum L.) and long pepper ( Piper longum L.), but it also occurs in Grains of Paradise ( Aframomum melegueta K. Schum.). ( E,E ) piperine is the isomeric form which is used in food supplements. Several isomers structurally related to ( E,E )-piperine are found in pepper with less hot taste, including isopiperine, chavicine and isochavicine. In the European/Western cuisine, black pepper is the major source of piperine in the human diet. Other sources in the diet are piperine (pepper)flavoured finished food products, including beverages and spirits. Piperine is also used in cosmetics as a perfuming agent (CosIng, 2016). The range of doses reported to cause interactions with drugs and phytochemicals when studied in vivo , 5 to 20 mg/kg bw per day in humans and 10 to 50 mg/kg bw per day in animals (Chinta et al., 2015; Srinivasan, 2007; Srinivasan, 2013), exceeded estimated daily intake levels of piperine. Provided that the ingestion of piperine via pepper (food flavouring) or intake of dietary supplements containing P. nigrum or P. longum does not exceed common dietary levels, the risk of adverse piperine-drug and piperine-phytochemical interactions is minimal. Based on a 90-day toxicity study in rats, a no observed adverse effect level (NOAEL) of 5 mg/kg bw per day was set in 2015 by the European Food Safety Authority (EFSA). In the present risk assessment, VKM has used this NOAEL of 5 mg/kg bw per day for the risk characterisation. The risk characterisation is based on the margin of exposure (MOE) approach; the ratio of the NOAEL to the exposure. An acceptable MOE value for a NOAEL-based assessment of piperine based on an animal study is ≥100, which includes a factor 10 for extrapolation from animals to humans and a factor 10 for interindividual human variation. From a daily dose of 1.5 mg piperine, the calculated intake levels are 34.6, 24.5, and 21.4 µg/kg bw per day for children (10 to <14 years), adolescents (14 to <18 years) and adults (³18 years), respectively. Using the MOE approach, for a daily intake of 1.5 mg piperine from food supplements and a NOAEL of 5 mg/kg bw per day, the MOE values are 145, 204 and 234 for children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years), respectively. Thus, for a daily intake of 1.5 mg piperine, the MOE values are above 100 for all age groups. VKM concludes that it is unlikely that a daily dose of 1.5 mg piperine from food supplements causes adverse health effects in children (10 to <14 years), adolescents (14 to <18 years) and adults (≥18 years).

Anti-inflammatory evaluation and acute toxicity of three food supplements that contain Moussonia deppeana

Objective To identify the anti-inflammatory activity through two murine models and in the median Lethal Dose (LD

Anti-inflammatory evaluation and acute toxicity of three food supplements that contain Moussonia deppeana

OBJECTIVE@#To identify the anti-inflammatory activity through two murine models and in the median Lethal Dose (LD) of three dietary supplements that contain Moussonia deppeana.@*METHODS@#The anti-inflammatory activity of three dietary supplements (Cicatrisan/Gastricus, Gastinol, and Gastrovita) EtOH extracts was evaluated by TPA and by carrageenan murine models; also, median Lethal Dose (LD) was determined. Verbascoside was quantified by High-Performance Liquid Chromatography. β-sitosterol, stigmasterol and the mixture of ursolic and oleanolic acids were identified in all supplements by TLC; however, none of these dietary supplements contain verbascoside.@*RESULTS@#For the TPA model, Cicatrisan/Gastricus generated a notable effect with 38.24% inhibition. While in the carrageenan model, it also exhibited noteworthy anti-inflammatory activity of ear edema with 66.39% of paw edema inhibition at 150 mg/kg, followed by Gastinol and Gastrovita with ≈50% at 300 mg/kg. Finally, LD was >2 g/kg for all supplements, when was administered intragastrically and Body Weight (BW) gain in mice was not altered after 14 days.@*CONCLUSIONS@#Of the three food supplements containing M. deppeana, only the EtOH extract from Cicatrisan/Gastricus formulation (tablets) showed significant anti-inflammatory activity in both experimental models and the LD was >2 g/kg.

Supplements in the European Union: An Analysis of Health Claims Related to Articular Joint Health.

In the European Union, amino acids, enzymes, pre- and probiotics, essential fatty acids, botanicals and botanical extracts and miscellaneous bioactive substances can be marketed as food supplements (FS). Food supplements that are meant to benefit human health contain claims on their label stating their benefits. Since 2007, health claims made on FS, are prohibited unless they are authorized and included in the EU Register of Nutrition and Health Claims on Food (the EU Register), in accordance with the requirements of Regulation (EC) nº 1924/2006. Aims: This manuscript reviews the evidence required to support health claims made on FS considering the legal framework of these foodstuffs and, as a case study, analyses the health claims on articular joint health included in the EU Register. The EFSA scientific opinions related to those health claims have also been considered. In EU, some botanicals and miscellaneous bioactive substances can be marketed as medicinal or as food supplements. The regulatory issues on botanicals and the debate on how to create a regulatory framework for botanicals is mentioned. Results: By April 2015, 77 functional health claims on joints health were included in the EU Register. The status of all these claims was non-authorised. The great majority were Article 13.1 claims (91%). All functional claims related to articular joints function were made on target functional ingredients, mainly other substances that could be used in the manufacturing of FS. Human trials conducted in diseased population were the main statement from EFSA for the non-approval of the health claims on articular joints. Criteria and more guidance addressing methodological issues on human trials would benefit future applications and scientific research. Conclusion: Legal issues regarding other substances than vitamins and minerals, namely botanical ingredients should also be taken in account in future FS health claims on articular joints. On this subject, efforts to improve the existing regulatory framework, namely with regard to botanicals products could also benefit future FS health claims.

Mineral Intake in Urban Pregnant Women from Base Diet, Fortified Foods, and Food Supplements: Focus on Calcium, Iron, and Zinc / 生物医学与环境科学（英文）

In the Chinese national nutrition surveys, fortified foods were not investigated separately from the base diet, and the contribution of fortified foods to micronutrients intake is not very clear. This study investigated the diet, including fortified foods and food supplements, of urban pregnant women and analyzed the intake of calcium, iron, and zinc to assess the corresponding contributions of fortified foods, food supplements, and the base diet. The results demonstrated that the base diet was the major source of calcium, iron, and zinc, and was recommended to be the first choice for micronutrients intake. Furthermore, consumption of fortified foods and food supplements offered effective approaches to improve the dietary intake of calcium, iron, and zinc in Chinese urban pregnant women.

CONHECIMENTO SOBRE NUTRIÇÃO E CONSUMO DE SUPLEMENTOS EM ACADEMIAS DE GINÁSTICA DE JUIZ DE FORA, BRASIL / KNOWLEDGE ON NUTRITION AND SUPPLEMENT CONSUMPTION AT FITNESS CENTERS IN THE CITY OF JUIZ DE FORA, BRAZIL / CONOCIMIENTO SOBRE NUTRICIÓN Y CONSUMO DE SUPLEMENTOS EN GIMNASIOS EN LA CIUDAD DE JUIZ DE FORA, BRASIL

Introdução O consumo de suplementos alimentares tem ganhado destaque entre desportistas. Contudo, mudanças nos hábitos alimentares são menos expressivas nesta população. Objetivo Verificar o uso de suplementos alimentares e o conhecimento sobre princípios básicos de nutrição de desportistas frequentadores de academias da cidade de Juiz de Fora, MG, Brasil. Métodos Estudo transversal, em 19 academias selecionadas por sorteio. A amostra totalizou 348 indivíduos maiores de 18 anos, de ambos os sexos, frequentadores das academias participantes, que concordaram em responder ao questionário contendo questões relacionadas aos dados sociodemográficos, prática de atividade física, conhecimento sobre nutrição e uso de suplementos alimentares. Resultados Dos participantes, 55% afirmaram se sentir insatisfeitos com o peso. Ao verificar o conhecimento prévio dos participantes sobre nutrição, 41,5% afirmaram que os micronutrientes são fornecedores de calorias; 79% da amostra conhecem a função dos macronutrientes, contudo desconhecem, na totalidade, as principais fontes alimentares dos mesmos. A proteína foi o nutriente que segundo 66% dos entrevistados deveria estar em maior proporção na dieta. Dos 54% de participantes que fazem uso de suplementos 43,9% utilizam um suplemento, 19,1% dois, 30,5% de três a quatro e 6,3% mais de quatro por dia. A orientação para este consumo partiu 34,2% das vezes do nutricionista, 31% do educador físico, seguido por outros meios de indicação; o objetivo de ganho de massa magra foi o mais citado (58,2%). Conclusão Este trabalho demonstrou elevado consumo de suplementos, insatisfação corporal e equívocos sobre conceitos básicos em nutrição.

Introduction The consumption of food supplements has been gaining prestige among athletes. However, changes in eating habits are less expressive in this population. Objective To verify the use of food supplements by athlete-users of fitness centers in the city of Juiz de Fora, MG, Brazil as well as their knowledge of the basic principles of nutrition. Methods Cross-sectional study in 19 fitness centers selected using a drawing. The sample included 348 participants over age 18 of both sexes who are users of the selected fitness centers and who agreed to answer a questionnaire containing questions related to sociodemographic data, physical activity, knowledge of nutrition, and use of food supplements. Results Fifty-five percent of participants said they feel dissatisfied with their weight. When checking participants' background knowledge of nutrition, 41.5% said that micronutrients supply calories, 79% of the sample knew the function of macronutrients, but all respondents were not aware of the main food sources of these macronutrients. According to 66% of respondents, protein is the nutrient that should make up the greatest proportion of the diet. Out of the 54% of participants who use supplements, 43.9% use one supplement, 19.1% use two, 30.5% use three to four and 6.3% use more than four per day. Of this group, 34.2% said they were advised on the use of supplements by a nutritionist, while 31% were advised by a physical educator, followed by other means of receiving recommendations. The most frequently mentioned goal was lean mass gain (58.2%). Conclusion This study showed high consumption of supplements, body dissatisfaction and misconceptions about basic concepts of nutrition.

Introducción El consumo de suplementos alimenticios ha ganado prominencia entre los deportistas. Sin embargo, los cambios en los hábitos alimenticios son menos expresivos en esta población. Objetivo Investigar el uso de suplementos alimenticios y el conocimiento sobre los principios básicos de la nutrición de los deportistas de gimnasios en la ciudad de Juiz de Fora, MG, Brasil. Métodos Estudio transversal en 19 gimnasios seleccionados por sorteo. La muestra consistió de 348 sujetos mayores de 18 años, de ambos sexos, asistentes de los gimnasios participantes, que aceptaran participar y contestar el cuestionario con preguntas relacionadas con datos socio-demográficos, la práctica de actividad física, conocimientos de nutrición y el uso de suplementos alimenticios. Resultados Del total de los participantes, el 55% dijeron sentirse insatisfechos con el peso. Tras un análisis de los antecedentes de los participantes acerca de la nutrición, el 41,5% dijeron que los micronutrientes son proveedores de calorías; el 79% de la muestra tuvieran conocimiento de la función de los macronutrientes, pero ignoran por completo las principales fuentes de los mismos. La proteína fue el nutriente que de acuerdo con el 66% de los participantes, tiene que estar en mayor proporción en la dieta. Del 54% de los participantes que usan suplementos, el 43,9% utilizan un suplemento, el 19,1% dos; el 30,5% tres a cuatro y el 6,3% más de cuatro por día. La orientación de un nutricionista en el consumo de suplementos fue del 34,2%, el 31% del educador físico, seguido por otros medios de indicación; el objetivo de aumento de masa magra fue la más citada (58,2%). Conclusión Este trabajo demostró un alto consumo de suplementos, de insatisfacción corporal y nociones erróneas acerca de conceptos básicos de nutrición.

Developing the Right Public Health Strategies for Folic Acid and Reduction of Risk of Neural Tube Defects (NTDs) in the United Kingdom.

The UK urgently needs a public health strategy for NTD reduction, which could include the use of food supplements, food fortification or a combination of both. An updated nutritional benefit-risk analysis is needed to inform population-based and/or targeted public health policies for folic acid intake and reduction of risk of neural tube defects. Policymakers should be cautious about the long-term exposure of the population as a whole to additional folic acid, especially potential adverse effects on the nervous system and brain function in older people, and higher levels of intake during infancy and childhood. The European-wide authorised health claim for folic acid food supplements and reduced risk of NTDs could transform the communication of the health benefits for women of childbearing age. Vitamin B12 deficiency may be an independent risk factor for NTDs, in which case dietary interventions with folic acid combined with vitamin B12 need to be considered.

Homologous human milk supplement for very low birth weight preterm infant feeding / Aditivo homólogo para a alimentação do recém-nascido pré-termo de muito baixo peso

OBJECTIVE: To develop a homologous human milk supplement for very low-birth weight infant feeding, using an original and simplified methodology, to know the nutritional composition of human milk fortified with this supplement and to evaluate its suitability for feeding these infants. METHODS: For the production and analysis of human milk with the homologous additive, 25 human milk samples of 45mL underwent a lactose removal process, lyophilization and then were diluted in 50mL of human milk. Measurements of lactose, proteins, lipids, energy, sodium, potassium, calcium, phosphorus and osmolality were performed. RESULTS: The composition of the supplemented milk was: lactose 9.22±1.00g/dL; proteins 2.20±0.36g/dL; lipids 2.91±0.57g/dL; calories 71.93±8.69kcal/dL; osmolality 389.6±32.4mOsmol/kgH2O; sodium 2.04±0.45mEq/dL; potassium 1.42±0.15mEq/dL; calcium 43.44±2.98mg/dL; and phosphorus 23.69±1.24mg/dL. CONCLUSIONS: According to the nutritional contents analyzed, except for calcium and phosphorus, human milk with the proposed supplement can meet the nutritional needs of the very low-birth weight preterm infant. .

OBJETIVO: Elaborar com metodologia original e simplificada um aditivo homólogo do leite humano para a alimentação do recém-nascido de muito baixo peso, conhecer a composição nutricional do leite humano fortificado com esse aditivo e avaliar sua adequação para a alimentação desses recém-nascidos. MÉTODOS: Para a produção e análise do leite humano com o aditivo homólogo, 25 amostras de 45 mL de leite humano passaram por processos de retirada de lactose, liofilização e foram diluídas em 50 mL de leite humano. Foram feitas dosagens de lactose, proteínas, lipídios, energia, sódio, potássio, cálcio, fósforo e osmolalidade. RESULTADOS: A composição do leite aditivado foi lactose 9,22 ± 1 g/dL; proteínas 2,20 ± 0,36 g/dL; lípides 2,91 ± 0,57 g/dL; calorias 71,93 ± 8,69 kcal/dL; osmolalidade 389,6 ± 32,4mOsmol/kgH2O; sódio 2,04 ± 0,45mEq/dL; potássio 1,42 ± 0,15mEq/dL; cálcio 43,44 ± 2,98 mg/dL; e fósforo 23,69 ± 1,24 mg/dL. CONCLUSÕES: De acordo com os teores nutricionais analisados, com exceção do cálcio e do fósforo, o leite humano com o aditivo proposto pode atender às necessidades nutricionais do recém-nascido pré-termo de muito baixo peso. .

Marketing approaches and regulation analysis for Chinese materia medica products in European Union / 中草药

As European Union (EU) is one of the largest herbal markets in the world, EU registration is an important way for the internationalization of Chinese materia medica products. According to the current EU legislation, Chinese materia medica products can access to the EU market in the form of food supplements, drugs, cosmetics, and medical devices. This article discusses the main EU marketing approaches related regulations such as application of food supplements, well-established use (WEU), and traditional use (TU) of medicine. The purpose is to clarify the feasible way of EU registration for Chinese materia medica products and to provide reference for the Chinese enterprises which are aspiring to open up the EU market.

Acute oral toxicity study of the crude ethanolic leaf extract of ficus pseudopalma blanco (moraceae) in sprague dawley rats.

Ficus pseudopalma Blanco is an ornamental plant endemic to the Philippines, especially in the island of Luzon. It is commonly used to treat kidney stones and diabetes and used for edible fruits. The leaves are cooked and eaten as vegetable despite the absence of studies on its possible toxic effect. This study was conducted to assess any toxicity of its leaf extract. Acute oral toxicity of the crude ethanolic leaf extract of F. pseudoplama was performed according to the guidelines set by OECD 425 on six 8-12 week old female Sprague Dawley rats weighing from 160-210g. One rat was treated with normal saline solution that served as the control. Toxicological and pharmacological observations were completed for 14 days. On day 14, all test animals were sacrificed via cervical dislocation and subjected to gross necropsy; liver samples were subjected to histopathological examination. Gross examination of the rodent’s organs was all normal and regarded as unremarkable. Toxicological screening showed that the experimentally treated rats behaved almost normally as the control. Histopathological examination showed no area of hepatic zonal necrosis and tumor formation was identified, no cytological aypia and sinusoid congestion, intact and uninterrupted hepatic lobular architecture, and portal tracts and vessels were unremarkable. These findings strongly suggest that the leaf extract is non toxic and safe for consumption up to 2000 mg/kg BW and may therefore be used for future nutraceuticals and drug development.

Efecto de la suplementación con grasas protegidas sobre parámetros productivos y reproductivos en vacas lactantes / Effect of protected fat supplementation on productive and reproductive performance in lactating cow

Objetivo. Investigar el efecto de la suplementación con jabones cálcicos protegidos, conteniendo ácidos grasos omega 3 ó 6 sobre la producción, composición de la leche y desempeño reproductivo. Materiales y métodos. Se utilizaron 24 vacas en un diseño mixto desde 20 días antes de la fecha prevista del parto hasta 105 días postparto, asignadas a los diferentes tratamientos; C: dieta control, O6: animales suplementados con grasas protegidas conteniendo omega 6 y O3: animales suplementados con grasas protegidas conteniendo omega 3. Se determinó la producción y la composición de la leche, así como la condición corporal (CC), el primer calor y primera ovulación posparto. Resultados. La suplementación con omega 3 ó 6 no afectó la producción láctea, ni los porcentajes de grasa, proteína, sólidos no grasos (SNG) y sólidos totales (ST). Sin embargo, hubo un efecto positivo a los 45 días posparto sobre la CC cuando los animales fueron suplementados con omega 6 (p<0.05) lo que se reflejó en una recuperación ovárica posparto más rápida (42.24±16.75 días a la primera ovulación posparto). Conclusiones. La utilización de la suplementación con omega 6 mejoró la condición corporal de los animales en el posparto temprano, disminuyendo los días a la primera ovulación y primer calor posparto, sin afectar la producción ni composición de la leche. La suplementación con omega 3 no influyó en ningún parámetro productivo en el posparto temprano.

Objective. To investigate the effects of supplements with protected fat such as calcium soaps containing omega 3 or 6 milk production, composition and reproductive performance. Materials and methods. Twenty-four Holstein cows were used in a mixed model design. From 20 days before calving until 105 days postpartum, cows were assigned to different treatments; C: control diet, O6: animals supplemented with protected unsaturated fat including a higher amount of omega, 6 and O3: animals fed with protected unsaturated fat including higher amounts of omega 3. Milk volume and composition, and body condition score (CC) were determined, along with the first postpartum heat and ovulation. Results. Supplementation with omega 3 or 6 had no effect on milk volume, and fat percentages, protein, milk non-fat solids (SNF) and total solids (ST). However, there is a positive effect of omega 6 supplementation on the CC at 45 days postpartum (p<0.05). This was also reflected in a faster ovarian recovery (42.24±16.75 days to first postpartum ovulation). Conclusions. The use of omega 6 supplementation improves body condition score of animals during early postpartum, decreasing the days to the first ovulation and postpartum heat without affecting the volume or composition of the milk. Supplementation with omega 3 does not affect any productive parameters in the early postpartum.

Herbal Reference Standards: applications, definitions and regulatory requirements

This review concerns the definitions and appropriate analytical characterisations of herbal reference standards within the framework of regulatory requirements. It describes currently applicable rules and regulations, as well as future issues relating to the European Pharmacopoeia and United States Pharmacopoeia. It provides an update on the use and availability of pharmacopoeial (EP and USP) herbal reference standards since our last review was published in 2009. The continuing challenges facing manufacturers, suppliers and analysts are discussed on the basis of exemplary reference substances for herbal products in medicinal and food products. The article also reviews the special aspects of Brazilian stipulations (Brazilian Pharmacopoeia, Anvisa) by comparison with European regulations. The term herbal products as used throughout this article refers to herbal drugs, herbal preparations and finished herbal medicinal products unless a different meaning is obvious from the context. More specific terms are used where necessary.

Fatores associados ao uso de suplementos em recém-natos em alojamento conjunto no município do Rio de Janeiro, 2009 / Factors associated with the use of supplements among newborns in communal wards in Rio de Janeiro, 2009

O Hospital Amigo da Criança preconiza só dar leite materno a recém-nascidos, a não ser que haja indicação médica". O objetivo foi estimar a prevalência do uso de suplementos em recém-natos e analisar os fatores associados a este. Estudo transversal realizado em 2009 mediante entrevista a amostra representativa de 687 mães em alojamento conjunto em 15 hospitais do Sistema Único de Saúde no município do Rio de Janeiro. Foram obtidas razões de prevalência do uso de suplementos por regressão de Poisson com variância robusta, segundo modelo hierarquizado. A prevalência de uso de suplementos foi de 49,8%, tendo como fatores associados: realização de teste rápido anti-HIV (RP = 1,37; IC95%:1,18-1,58), parto cesáreo (RP = 1,57; IC95%:1,38-1,79), não ajuda na sala de parto para amamentar (RP = 1,60; IC95%:1,29-1,99), afastamento do bebê de sua mãe (RP = 1,24; IC95%:1,05-1,46), uso de chupeta (RP = 1,31; IC95%:1,08-1,58), intercorrências maternas ou neonatais (RP = 1,56; IC95%:1,34-1,82), certificação como HAC (RP = 0,52; IC95%:0,44-0,61) e não recebimento de ajuda no alojamento conjunto para amamentar (RP = 0,78; IC95%:0,66-0,92). A suplementação ao leite materno vem sendo amplamente utilizada. Rotinas hospitalares devem ser revistas para que o aleitamento materno exclusivo converta-se em norma.

The scope of this study was to estimate the prevalence of the use of supplements among newborns and analyze the factors associated with their use. A cross-sectional study was conducted in 2009 with a representative sample of 687 mothers interviewed in 15 communal wards in hospitals of the Unified Health System in the city of Rio de Janeiro. Prevalence ratios (PR) of supplement use were obtained by Poisson Regression with robust variance, using a hierarchical model. The prevalence of supplement use was 49.8%. Factors associated with supplement use were: being submitted to the rapid HIV test (PR = 1.37; CI95%:1.18-1.58); cesarean delivery (PR = 1.57; CI95%:1.38-1.79); not being helped to breastfeed in the delivery room (PR = 1.60; CI95%:1.29-1.99); mother-child separation (PR = 1.24; CI95%:1.05-1.46); pacifier use (PR = 1.31; CI95%:1.08-1.58); maternal or neonatal interventions (PR = 1.56; CI95%:1.34-1.82); BFH certification (PR = 0.52; CI95%:0.44-0.61); and not receiving help to breastfeed in the communal ward (PR = 0.78; CI95%:0.66-0.92). Supplements to breast milk are being widely used. Hospital routines should be reviewed, so that exclusive breastfeeding becomes the norm.

Scientific Opinion on the Regulatory Status of 1,3-Dimethylamylamine (DMAA).

1,3-Dimethylamylamine (DMAA) is a pressor amine often found in food supplements for athletes at dosages of 25-65 mg. Historically, the compound has been used as a nasal decongestant but its oral application is largely unstudied leaving the regulatory status of such food supplements as unlicensed medicines undetermined. We therefore reviewed the literature on DMAA and similar amines in order to deduce an effective oral dosage. Based on our findings we conclude that oral preparations with >4 mg DMAA per dose unit should be considered as effective as a bronchodilator. Food supplements that exceed that limit are in fact subject to the Medicines Act and require licensing. Dosages higher than 100-200 mg are expected to cause serious adverse events.

Effect of Nigella sativa seeds extracts on iNOS through antioxidant potential only: Crude/total extract as molecular therapy drug.

There is general belief that only pure phytomolecules may be used as molecular therapeutic agent through one to one action. However, the traditional systems of medicine e.g. Ayurveda, uses the crude extracts, mostly water decoctions and oils, as drug. A comparative study of hexane, ethyl acetate and methanol fractions of N. Sativa seeds has been carried out on fresh rat-peritoneal-macrophage culture with reference to their role on various targets of lipopolysaccharide induced release of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) expression. The results indicated significant antioxidant potential with methanolic extract as most effective. Its mechanism of action was proposed primarily through its antioxidant potential and not through direct inhibition of other kinases, involved in its signaling cascade.