Massey Research Online - Browsing by Author "Sjödin A"

Browsing by Author "Sjödin A"

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A period of 10 weeks of increased protein consumption does not alter faecal microbiota or volatile metabolites in healthy older men: a randomised controlled trial
(Cambridge University Press on behalf of The Nutrition Society, 2020-07-02) Mitchell SM; McKenzie EJ; Mitchell CJ; Milan AM; Zeng N; D'Souza RF; Ramzan F; Sharma P; Rettedal E; Knowles SO; Roy NC; Sjödin A; Wagner K-H; O'Sullivan JM; Cameron-Smith D
Diet has a major influence on the composition and metabolic output of the gut microbiome. Higher-protein diets are often recommended for older consumers; however, the effect of high-protein diets on the gut microbiota and faecal volatile organic compounds (VOC) of elderly participants is unknown. The purpose of the study was to establish if the faecal microbiota composition and VOC in older men are different after a diet containing the recommended dietary intake (RDA) of protein compared with a diet containing twice the RDA (2RDA). Healthy males (74⋅2 (sd 3⋅6) years; n 28) were randomised to consume the RDA of protein (0⋅8 g protein/kg body weight per d) or 2RDA, for 10 weeks. Dietary protein was provided via whole foods rather than supplementation or fortification. The diets were matched for dietary fibre from fruit and vegetables. Faecal samples were collected pre- and post-intervention for microbiota profiling by 16S ribosomal RNA amplicon sequencing and VOC analysis by head space/solid-phase microextraction/GC-MS. After correcting for multiple comparisons, no significant differences in the abundance of faecal microbiota or VOC associated with protein fermentation were evident between the RDA and 2RDA diets. Therefore, in the present study, a twofold difference in dietary protein intake did not alter gut microbiota or VOC indicative of altered protein fermentation.
Black tea and improvement of attention: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-05-24) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
Following an application from Unilever NV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to black tea and improvement of attention. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is black tea. The Panel considers that black tea characterised by its content of tea solids, caffeine and l-theanine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'improves attention'. The Panel considers that improvement of attention is a beneficial physiological effect. Three human intervention studies provided by the applicant show an effect of black tea on attention under the conditions of used proposed by the applicant. The applicant proposed that the claimed effect depends on the concerted action of two substances, caffeine and l-theanine, both of which are present in black tea. The Panel considers that the effect of black tea on attention observed in the three human intervention studies provided by the applicant can be explained by its caffeine content. The Panel concludes that a cause and effect relationship has been established between the consumption of black tea and improvement of attention. The Panel considers that the effect of black tea on attention can be explained by its caffeine content. The following wording reflects the scientific evidence: 'Owing to its caffeine content, black tea improves attention'. In order to obtain the claimed effect, 2-3 servings of black tea providing at least 75 mg of caffeine in total should be consumed within 90 min.
Black tea and maintenance of normal endothelium-dependent vasodilation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-01-16) EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA panel); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdor I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
Following an application from Unilever NV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to black tea and maintenance of normal endothelium-dependent vasodilation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is black tea beverages, either freshly prepared or reconstituted from water extract powders of black tea, characterised by the content of flavanols (expressed as catechins plus theaflavins) of at least 30 mg per 200 mL serving. The Panel considers that black tea characterised by the content of flavanols (expressed as catechins plus theaflavins) is sufficiently characterised. The claimed effect proposed by the applicant is 'improvement of endothelium-dependent vasodilation'. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. Of the five human intervention studies provided on the chronic effect of black tea consumption on endothelium-dependent vasodilation, two investigated the effect after regular consumption of black tea for a sufficiently long time period (i.e. at least 4 weeks). These two studies did not allow an effect of black tea on endothelium-dependent vasodilation to be established. The Panel concludes that a cause and effect relationship has not been established between the consumption of black tea and maintenance of normal endothelium-dependent vasodilation.
Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1)2
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2021-03-26) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Products; Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Siani A; Sjödin A; Stern M; Tomé D; Vinceti M; Willatts P; Engel K-H; Marchelli R; Pöting A; Poulsen M; Salminen S; Schlatter J; Arcella D; Gelbmann W; de Sesmaisons-Lecarré A; Verhagen H; van Loveren H
Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well-structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. This guidance was originally adopted in 2016.It has been revised to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain. This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.
Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1)
(John Wiley and Sons Ltd on behalf of the European Food Safety Authority, 2021-03-26) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Siani A; Sjödin A; Stern M; Tomé D; Vinceti M; Willatts P; Engel K-H; Marchelli R; Pöting A; Poulsen M; Schlatter J; Gelbmann W; de Sesmaisons-Lecarré A; Verhagen H; van Loveren H
Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.
Guidance on the scientific requirements for health claims related to muscle function and physical performance: (Revision 1)
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-10-30) EFSA Panel on Nutrition, Novel Foods and Food Allergens (EFSA NDA Panel); Turck D; Castenmiller J; De Henauw S; Hirsch-Ernst KI; Kearney J; Knutsen HK; Maciuk A; Mangelsdorf I; McArdle HJ; Naska A; Pelaez C; Pentieva K; Thies F; Tsabouri S; Vinceti M; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Neuhäuser-Berthold M; Nowicka G; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Willatts P; Martin A; Strain JJ; Heng L; Martínez SV; Siani A
EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.
Impact of a High Protein Intake on the Plasma Metabolome in Elderly Males: 10 Week Randomized Dietary Intervention
(Frontiers Media S.A., 2019-12-06) Durainayagam B; Mitchell CJ; Milan AM; Zeng N; Sharma P; Mitchell SM; Ramzan F; Knowles SO; Sjödin A; Wagner K-H; Roy NC; Fraser K; Cameron-Smith D
High protein diets may improve the maintenance of skeletal muscle mass in the elderly, although it remains less clear what broader impact such diets have on whole body metabolic regulation in the elderly. Non-targeted polar metabolomics analysis using HILIC HPLC-MS was used to profile the circulating plasma metabolome of elderly men (n = 31; 74.7 ± 4.0 years) who were randomized to consume for 10 weeks a diet designed to achieve either protein (RDA; 0.8·g-1·kg-1) or that doubled this recommend intake (2RDA; 1.6.g.kg-1). A limited number of plasma metabolites (n = 24) were significantly differentially regulated by the diet. These included markers of protein anabolism, which increased by the 2RDA diet, including; urea, creatine, and glutarylcarnitine. Whilst in response to the RDA diet; glutamine, glutamic acid, and proline were increased, relative to the 2RDA diet (p < 0.05). Metaboanalyst identified six major metabolic pathways to be influenced by the quantity of protein intake, most notably the arginine and proline pathways. Doubling of the recommended protein intake in older males over 10 weeks exerted only a limited impact on circulating metabolites, as determined by LC-MS. This metabolomic response was almost entirely due to increased circulating abundances of metabolites potentially indicative of altered protein anabolism, without evidence of impact on pathways for metabolic health. Trial Registration: This trial was registered on 3rd March 2016 at the Australia New Zealand Clinical Trial Registry (www.anzctr.org.au) at ACTRN 12616000310460.
L-carnitine and contribution to normal lipid metabolism: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-01-16) EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panel considers that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is 'normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panel considers that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panel considers that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panel concludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population.
NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-01-18) EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
Following an application from Newtricious R&D B.V., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is 'reduces loss of vision'. The target population proposed by the applicant is 'healthy adults over 50 years of age'. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.
Protein Intake at Twice the RDA in Older Men Increases Circulatory Concentrations of the Microbiome Metabolite Trimethylamine-N-Oxide (TMAO)
(MDPI (Basel, Switzerland), 2019-09-12) Mitchell SM; Milan AM; Mitchell CJ; Gillies NA; D'Souza RF; Zeng N; Ramzan F; Sharma P; Knowles SO; Roy NC; Sjödin A; Wagner K-H; Zeisel SH; Cameron-Smith D
Higher dietary protein intake is increasingly recommended for the elderly; however, high protein diets have also been linked to increased cardiovascular disease (CVD) risk. Trimethylamine-N-oxide (TMAO) is a bacterial metabolite derived from choline and carnitine abundant from animal protein-rich foods. TMAO may be a novel biomarker for heightened CVD risk. The purpose of this study was to assess the impact of a high protein diet on TMAO. Healthy men (74.2 ± 3.6 years, n = 29) were randomised to consume the recommended dietary allowance of protein (RDA: 0.8 g protein/kg bodyweight/day) or twice the RDA (2RDA) as part of a supplied diet for 10 weeks. Fasting blood samples were collected pre- and post-intervention for measurement of TMAO, blood lipids, glucose tolerance, insulin sensitivity, and inflammatory biomarkers. An oral glucose tolerance test was also performed. In comparison with RDA, the 2RDA diet increased circulatory TMAO (p = 0.002) but unexpectedly decreased renal excretion of TMAO (p = 0.003). LDL cholesterol was increased in 2RDA compared to RDA (p = 0.049), but no differences in other biomarkers of CVD risk and insulin sensitivity were evident between groups. In conclusion, circulatory TMAO is responsive to changes in dietary protein intake in older healthy males.
Safety of d-ribose as a novel food pursuant to Regulation (EU) 2015/2283
(ohn Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-05-31) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle H; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Siani A; Sjödin A; Stern M; Tomé D; Vinceti M; Willatts P; Engel K-H; Marchelli R; Pöting A; Poulsen M; Schlatter JR; Germini A; Van Loveren H
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on D-ribose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF as ingredient in a variety of foods, food supplements and in certain foods for specific groups. The NF is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis and marketed as Bioenergy Ribose™. The information provided on the batch-to-batch variability, specifications, stability, production process and history of the organism used as a source of the NF is sufficient and does not raise safety concerns. The Panel considers that the effects observed in a subchronic toxicity study in rats could be the consequence of nutritional imbalances, but toxicological effects could not be ruled out; from this study, the Panel derived a No observed adverse effect level (NOAEL) of 3.6 g/kg body weight (bw) per day. From the human studies indicating a potential decrease in glucose levels and/or the occurrence of transient symptomatic hypoglycaemia at intakes of 10 g of d-ribose, the Panel defined 70 mg/kg bw per day as the NOAEL with respect to hypoglycaemia that can be considered applicable for adults. For children, the Panel acknowledges the lack of human data directly relevant for this population group. Based on the NOAEL derived from the subchronic toxicity study in rats, an acceptable level of intake of 36 mg/kg bw per day was defined that would also take into account the potentially increased sensitivity of certain population groups to hypoglycaemia. The Panel concludes that the NF is safe for the general population at intake levels up to 36 mg/kg bw per day and considers that the safety of the NF at the intended uses and use levels as proposed by the applicant has not been established.
Safety of xylo-oligosaccharides (XOS) as a novel food pursuant to Regulation (EU) 2015/2283
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-07-23) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Siani A; Sjödin A; Stern M; Tomé D; Vinceti M; Willatts P; Engel K-H; Marchelli R; Pöting A; Poulsen M; Schlatter JR; Turla E; van Loveren H
Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on a mixture of xylo-oligosaccharides (XOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained from corncobs (Zea mays subsp. mays) via enzyme-catalysed hydrolysis and subsequent purification. The main components of the NF, the oligosaccharides, are resistant to human digestive enzymes and are fermented by colonic bacteria. The intention is to add the NF to a variety of foods such as bakery and dairy products, fruit jelly, chocolates and soy-drinks. The information provided on composition, specifications, production process and stability of the NF, does not raise safety concerns. There were effects observed in the animal studies with the NF or with other XOS which were considered by the Panel to be expected from the intake of non-digestible carbohydrates. The Panel notes that the acute and transient gastrointestinal observed in human intervention studies with the NF or with other XOS have also been associated with the consumption of other non-digestible carbohydrates. The Panel concludes that the NF, a mixture of XOS, is safe under the proposed uses and use levels. The target population is the general population.
Symbiosal® and lowering of blood pressure and reduced risk of hypertension: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-07-25) EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
Following an application from Han-Biotech GmbH, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Symbiosal®, lowering of blood pressure and reduced risk of hypertension. The Panel considers that the food, Symbiosal®, which is the subject of the health claim, and the food, table salt, which Symbiosal® should replace, are sufficiently characterised. Lowering of blood pressure is a beneficial physiological effect. Increased blood pressure is a risk factor for hypertension. In weighing the evidence, the Panel took into account that one human study with some methodological limitations showed an effect of Symbiosal® on blood pressure in the context of a self-selected diet with a maximum of 3 g/day added salt. The Panel also took into account that no other human studies in which these results have been replicated were provided, that the animal studies did not support the results of the human study, that no evidence was provided in support of a mechanism by which Symbiosal® could induce a decrease in blood pressure upon oral consumption as compared to table salt in vivo in humans, and the low biological plausibility of the effect observed in the human intervention study. The Panel concludes that a cause and effect relationship has not been established between the consumption of Symbiosal® and lowering of blood pressure.
Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
(John Wiley and Sons Ltd on behalf of European Food Safety Authority, 2018-03-13) EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck D; Bresson J-L; Burlingame B; Dean T; Fairweather-Tait S; Heinonen M; Hirsch-Ernst KI; Mangelsdorf I; McArdle HJ; Naska A; Neuhäuser-Berthold M; Nowicka G; Pentieva K; Sanz Y; Sjödin A; Stern M; Tomé D; Van Loveren H; Vinceti M; Willatts P; Martin A; Strain SJJ; Siani A
Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is 'helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body'. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.

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