The Experts below are selected from a list of 62799 Experts worldwide ranked by ideXlab platform
Daniela Martini - One of the best experts on this subject based on the ideXlab platform.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 and related to cognitive function in adults
Archives Italiennes De Biologie, 2018Co-Authors: Daniela Martini, Giorgio Bedogni, I Zavaroni, Marco Ventura, Augusto Innocenti, Chiara Cosentino, Daniela Galli, Prisco Mirandola, Marilena Vitale, Dei A CasAbstract:Some food/food components have been the object of request of authorization to the use of Health Claims related to cognitive function in adults and compliant with the Regulation (EC) 1924/2006. Most of the requests have received a negative opinion by the European Food Safety Authority (EFSA) also because of the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs) selected in the trials used to substantiate the claim. This manuscript referes to the collection, collation and critical analysis of OVs and MMs related to cognitive function in adults. OVs and MMs were collected from the EFSA Guidance document and the applications for authorization of Health Claims pursuant to the Articles 13(5). The critical analysis of OVs and MMs, performed by a literature review, was aimed at defining their appropriateness in the context of a specific claimed effect. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the Claims related to cognitive functioning. The information provided in this document may serve to EFSA for updating the guidance on the scientific requirements for Health Claims related to cognitive functions, but also for a better design of randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under european community regulation 1924 2006 in the area of appetite ratings and weight management
International Journal of Food Sciences and Nutrition, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Stefano Rossi, M Musci, Giovanni Passeri, Daniela GalliAbstract:All the requests for authorisation to bear Health Claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing Health Claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 in the framework of bone Health
PharmaNutrition, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, Laura Marchi, I Zavaroni, Carlo Pruneti, Marco VenturaAbstract:Abstract Several foods or food components have been the object of application for authorization of Health Claims on bone Health, pursuant to Regulation (EC) 1924/2006. For most of them, the European Food Safety Authority (EFSA) has issued negative opinions mainly for reasons pertaining to an insufficient substantiation of the claim, incluiding the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs). The present manuscript refers to the collection, collation and critical analysis of OVs and MMs related to bone Health compliant with the Regulation. The definition of the keywords, the PubMed search strategies and the creation of databases of references were performed to critically analyse the OVs and their MMs on the basis of the literature review. The assessment of each OV and related MM was defined according to its appropriatness in relation to the claimed effects proposed. The results obtained are relevant for the choice of the best OVs and MMs, to be used not only for the substantiation of Health Claims on bone Health, but also in general research performed with different purposes. Moreover, the results can be used by EFSA during the update of guidance for the scientific requirements of Health Claims on bone Health.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under regulation ec 1924 2006 in the area of oral Health
NFS Journal, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela GalliAbstract:Abstract Objective Some of the requests of authorization to apply Health Claims in the context of oral Health have received a negative scientific opinion from the European Food Safety Authority (EFSA). The main reasons refer to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed at collecting, collating and critically analysing the information in relation to claimed effects, OVs and MMs, in the area of oral Health and compliant with Regulation (EC) 1924/2006. Methods Claimed effects, OVs and the related MMs were collected from EFSA guidance documents and from the scientific opinions on the substantiation of Health Claims under Articles 13.5 and 14. The collection, collation and critical analysis of the relevant scientific literature consisted in a definition of the keywords, PubMed search strategies and in the creation of databases of references. Results and conclusions The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context each specific claimed effect. Clinical significance The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for Health Claims related to oral Health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under european community regulation 1924 2006 in the area of blood glucose and insulin concentrations
Acta Diabetologica, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela Galli, M Musci, Giovanni Passeri, Prisco MirandolaAbstract:Most requests for authorization to bear Health Claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate Health Claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the Claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of Health Claims.
Marco Ventura - One of the best experts on this subject based on the ideXlab platform.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 and related to cognitive function in adults
Archives Italiennes De Biologie, 2018Co-Authors: Daniela Martini, Giorgio Bedogni, I Zavaroni, Marco Ventura, Augusto Innocenti, Chiara Cosentino, Daniela Galli, Prisco Mirandola, Marilena Vitale, Dei A CasAbstract:Some food/food components have been the object of request of authorization to the use of Health Claims related to cognitive function in adults and compliant with the Regulation (EC) 1924/2006. Most of the requests have received a negative opinion by the European Food Safety Authority (EFSA) also because of the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs) selected in the trials used to substantiate the claim. This manuscript referes to the collection, collation and critical analysis of OVs and MMs related to cognitive function in adults. OVs and MMs were collected from the EFSA Guidance document and the applications for authorization of Health Claims pursuant to the Articles 13(5). The critical analysis of OVs and MMs, performed by a literature review, was aimed at defining their appropriateness in the context of a specific claimed effect. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the Claims related to cognitive functioning. The information provided in this document may serve to EFSA for updating the guidance on the scientific requirements for Health Claims related to cognitive functions, but also for a better design of randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under european community regulation 1924 2006 in the area of appetite ratings and weight management
International Journal of Food Sciences and Nutrition, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Stefano Rossi, M Musci, Giovanni Passeri, Daniela GalliAbstract:All the requests for authorisation to bear Health Claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing Health Claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 in the framework of bone Health
PharmaNutrition, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, Laura Marchi, I Zavaroni, Carlo Pruneti, Marco VenturaAbstract:Abstract Several foods or food components have been the object of application for authorization of Health Claims on bone Health, pursuant to Regulation (EC) 1924/2006. For most of them, the European Food Safety Authority (EFSA) has issued negative opinions mainly for reasons pertaining to an insufficient substantiation of the claim, incluiding the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs). The present manuscript refers to the collection, collation and critical analysis of OVs and MMs related to bone Health compliant with the Regulation. The definition of the keywords, the PubMed search strategies and the creation of databases of references were performed to critically analyse the OVs and their MMs on the basis of the literature review. The assessment of each OV and related MM was defined according to its appropriatness in relation to the claimed effects proposed. The results obtained are relevant for the choice of the best OVs and MMs, to be used not only for the substantiation of Health Claims on bone Health, but also in general research performed with different purposes. Moreover, the results can be used by EFSA during the update of guidance for the scientific requirements of Health Claims on bone Health.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under regulation ec 1924 2006 in the area of oral Health
NFS Journal, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela GalliAbstract:Abstract Objective Some of the requests of authorization to apply Health Claims in the context of oral Health have received a negative scientific opinion from the European Food Safety Authority (EFSA). The main reasons refer to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed at collecting, collating and critically analysing the information in relation to claimed effects, OVs and MMs, in the area of oral Health and compliant with Regulation (EC) 1924/2006. Methods Claimed effects, OVs and the related MMs were collected from EFSA guidance documents and from the scientific opinions on the substantiation of Health Claims under Articles 13.5 and 14. The collection, collation and critical analysis of the relevant scientific literature consisted in a definition of the keywords, PubMed search strategies and in the creation of databases of references. Results and conclusions The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context each specific claimed effect. Clinical significance The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for Health Claims related to oral Health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under european community regulation 1924 2006 in the area of blood glucose and insulin concentrations
Acta Diabetologica, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela Galli, M Musci, Giovanni Passeri, Prisco MirandolaAbstract:Most requests for authorization to bear Health Claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate Health Claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the Claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of Health Claims.
Paula R Trumbo - One of the best experts on this subject based on the ideXlab platform.
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qualified Health claim for whole grain intake and risk of type 2 diabetes an evidence based review by the us food and drug administration
Nutrition Reviews, 2016Co-Authors: Sedigheh Yamini, Paula R TrumboAbstract:The objective of this review is to explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified Health claim on the role of whole-grain consumption in reducing the risk of type 2 diabetes. The labeling of Health Claims, including qualified Health Claims, on conventional foods and dietary supplements requires premarket approval by the FDA. Health Claims characterize the relationship between a substance (food or food component) and a disease (eg, diabetes or cardiovascular disease) or a Health-related condition (eg, hypertension). This review describes the FDA’s evaluation of intervention and observational studies that characterize a relationship between whole grains and type 2 diabetes. This evidence-based review provides very limited evidence to support a Health claim of a relationship between intake of whole grains and a reduced risk of type 2 diabetes.
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fda s Health claim review whey protein partially hydrolyzed infant formula and atopic dermatitis
Pediatrics, 2012Co-Authors: Carolyn S Chung, Sedigheh Yamini, Paula R TrumboAbstract:In this review, we explain how the US Food and Drug Administration (FDA) used its evidence-based review system to evaluate the scientific evidence for a qualified Health claim for 100% whey-protein partially hydrolyzed infant formula (W-PHF) and reduced risk of atopic dermatitis (AD). The labeling of Health Claims, including qualified Health Claims, on conventional foods and dietary supplements require premarket approval by the FDA. Health Claims characterize the relationship between a substance (food or food component) and disease (eg, cancer or cardiovascular disease) or Health-related condition (eg, hypertension). To determine whether sufficient evidence exists to support the qualified Health claim, the FDA evaluated human intervention studies that evaluated the role of W-PHF in reducing the risk of AD. The FDA concluded there is little to very little evidence, respectively, to support a qualified Health claim concerning the relationship between intake of W-PHF and a reduced risk of AD in partially breastfed and exclusively formula-fed infants throughout the first year after birth and up to 3 years of age. In addition, the FDA required a warning statement be displayed along with the Health claim to indicate to consumers that partially hydrolyzed infant formulas are not hypoallergenic and should not be fed to infants who are allergic to milk or to infants with existing milk allergy symptoms.
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chromium picolinate intake and risk of type 2 diabetes an evidence based review by the united states food and drug administration
Nutrition Reviews, 2006Co-Authors: Paula R Trumbo, Kathleen C EllwoodAbstract:The labeling of both Health Claims that meet significant scientific agreement (SSA) and qualified Health Claims on conventional foods and dietary supplements requires pre-market approval by the US Food and Drug Administration (FDA). Approval by the FDA involves, in part, a thorough review of the scientific evidence to support an SSA or a qualified Health claim. This article discusses FDA's evidence-based review of the scientific evidence on the role of chromium picolinate supplements in reducing the risk of type 2 diabetes. Based on this evidence-based review, FDA issued a letter of enforcement discretion for one qualified Health claim on chromium picolinate and risk of insulin resistance, a surrogate endpoint for type 2 diabetes. The agency concluded that the relationship between chromium picolinate intake and insulin resistance is highly uncertain.
Giorgio Bedogni - One of the best experts on this subject based on the ideXlab platform.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 and related to cognitive function in adults
Archives Italiennes De Biologie, 2018Co-Authors: Daniela Martini, Giorgio Bedogni, I Zavaroni, Marco Ventura, Augusto Innocenti, Chiara Cosentino, Daniela Galli, Prisco Mirandola, Marilena Vitale, Dei A CasAbstract:Some food/food components have been the object of request of authorization to the use of Health Claims related to cognitive function in adults and compliant with the Regulation (EC) 1924/2006. Most of the requests have received a negative opinion by the European Food Safety Authority (EFSA) also because of the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs) selected in the trials used to substantiate the claim. This manuscript referes to the collection, collation and critical analysis of OVs and MMs related to cognitive function in adults. OVs and MMs were collected from the EFSA Guidance document and the applications for authorization of Health Claims pursuant to the Articles 13(5). The critical analysis of OVs and MMs, performed by a literature review, was aimed at defining their appropriateness in the context of a specific claimed effect. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the Claims related to cognitive functioning. The information provided in this document may serve to EFSA for updating the guidance on the scientific requirements for Health Claims related to cognitive functions, but also for a better design of randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under european community regulation 1924 2006 in the area of appetite ratings and weight management
International Journal of Food Sciences and Nutrition, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Stefano Rossi, M Musci, Giovanni Passeri, Daniela GalliAbstract:All the requests for authorisation to bear Health Claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing Health Claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 in the framework of bone Health
PharmaNutrition, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, Laura Marchi, I Zavaroni, Carlo Pruneti, Marco VenturaAbstract:Abstract Several foods or food components have been the object of application for authorization of Health Claims on bone Health, pursuant to Regulation (EC) 1924/2006. For most of them, the European Food Safety Authority (EFSA) has issued negative opinions mainly for reasons pertaining to an insufficient substantiation of the claim, incluiding the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs). The present manuscript refers to the collection, collation and critical analysis of OVs and MMs related to bone Health compliant with the Regulation. The definition of the keywords, the PubMed search strategies and the creation of databases of references were performed to critically analyse the OVs and their MMs on the basis of the literature review. The assessment of each OV and related MM was defined according to its appropriatness in relation to the claimed effects proposed. The results obtained are relevant for the choice of the best OVs and MMs, to be used not only for the substantiation of Health Claims on bone Health, but also in general research performed with different purposes. Moreover, the results can be used by EFSA during the update of guidance for the scientific requirements of Health Claims on bone Health.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under regulation ec 1924 2006 in the area of oral Health
NFS Journal, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela GalliAbstract:Abstract Objective Some of the requests of authorization to apply Health Claims in the context of oral Health have received a negative scientific opinion from the European Food Safety Authority (EFSA). The main reasons refer to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed at collecting, collating and critically analysing the information in relation to claimed effects, OVs and MMs, in the area of oral Health and compliant with Regulation (EC) 1924/2006. Methods Claimed effects, OVs and the related MMs were collected from EFSA guidance documents and from the scientific opinions on the substantiation of Health Claims under Articles 13.5 and 14. The collection, collation and critical analysis of the relevant scientific literature consisted in a definition of the keywords, PubMed search strategies and in the creation of databases of references. Results and conclusions The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context each specific claimed effect. Clinical significance The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for Health Claims related to oral Health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under european community regulation 1924 2006 in the area of blood glucose and insulin concentrations
Acta Diabetologica, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela Galli, M Musci, Giovanni Passeri, Prisco MirandolaAbstract:Most requests for authorization to bear Health Claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate Health Claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the Claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of Health Claims.
I Zavaroni - One of the best experts on this subject based on the ideXlab platform.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 and related to cognitive function in adults
Archives Italiennes De Biologie, 2018Co-Authors: Daniela Martini, Giorgio Bedogni, I Zavaroni, Marco Ventura, Augusto Innocenti, Chiara Cosentino, Daniela Galli, Prisco Mirandola, Marilena Vitale, Dei A CasAbstract:Some food/food components have been the object of request of authorization to the use of Health Claims related to cognitive function in adults and compliant with the Regulation (EC) 1924/2006. Most of the requests have received a negative opinion by the European Food Safety Authority (EFSA) also because of the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs) selected in the trials used to substantiate the claim. This manuscript referes to the collection, collation and critical analysis of OVs and MMs related to cognitive function in adults. OVs and MMs were collected from the EFSA Guidance document and the applications for authorization of Health Claims pursuant to the Articles 13(5). The critical analysis of OVs and MMs, performed by a literature review, was aimed at defining their appropriateness in the context of a specific claimed effect. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the Claims related to cognitive functioning. The information provided in this document may serve to EFSA for updating the guidance on the scientific requirements for Health Claims related to cognitive functions, but also for a better design of randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under european community regulation 1924 2006 in the area of appetite ratings and weight management
International Journal of Food Sciences and Nutrition, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Stefano Rossi, M Musci, Giovanni Passeri, Daniela GalliAbstract:All the requests for authorisation to bear Health Claims under Articles 13(5) and 14 in the context of appetite ratings and weight management have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of the insufficient substantiation of the claimed effects (CEs). This manuscript results from an investigation aimed to collect, collate and critically analyse the information related to outcome variables (OVs) and methods of measurement (MMs) in the context of appetite ratings and weight management compliant with Regulation 1924/2006. Based on the literature review, the appropriateness of OVs and MMs was evaluated for specific CEs. This work might help EFSA in the development of updated guidance addressed to stakeholders interested in bearing Health Claims in the area of weight management. Moreover, it could drive the applicants during the design of randomised controlled trials aimed to substantiate such Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under regulation ec 1924 2006 in the framework of bone Health
PharmaNutrition, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, Laura Marchi, I Zavaroni, Carlo Pruneti, Marco VenturaAbstract:Abstract Several foods or food components have been the object of application for authorization of Health Claims on bone Health, pursuant to Regulation (EC) 1924/2006. For most of them, the European Food Safety Authority (EFSA) has issued negative opinions mainly for reasons pertaining to an insufficient substantiation of the claim, incluiding the choice of not appropriate outcome variables (OVs) and methods of measurement (MMs). The present manuscript refers to the collection, collation and critical analysis of OVs and MMs related to bone Health compliant with the Regulation. The definition of the keywords, the PubMed search strategies and the creation of databases of references were performed to critically analyse the OVs and their MMs on the basis of the literature review. The assessment of each OV and related MM was defined according to its appropriatness in relation to the claimed effects proposed. The results obtained are relevant for the choice of the best OVs and MMs, to be used not only for the substantiation of Health Claims on bone Health, but also in general research performed with different purposes. Moreover, the results can be used by EFSA during the update of guidance for the scientific requirements of Health Claims on bone Health.
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claimed effects outcome variables and methods of measurement for Health Claims on foods proposed under regulation ec 1924 2006 in the area of oral Health
NFS Journal, 2018Co-Authors: Daniela Martini, Cristina Guareschi, Beatrice Biasini, Giorgio Bedogni, Carlo Galli, Donato Angelino, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela GalliAbstract:Abstract Objective Some of the requests of authorization to apply Health Claims in the context of oral Health have received a negative scientific opinion from the European Food Safety Authority (EFSA). The main reasons refer to the design of human intervention studies, including the inappropriate choice of outcome variables (OVs) and of their methods of measurement (MMs). The present manuscript reports the results of an investigation aimed at collecting, collating and critically analysing the information in relation to claimed effects, OVs and MMs, in the area of oral Health and compliant with Regulation (EC) 1924/2006. Methods Claimed effects, OVs and the related MMs were collected from EFSA guidance documents and from the scientific opinions on the substantiation of Health Claims under Articles 13.5 and 14. The collection, collation and critical analysis of the relevant scientific literature consisted in a definition of the keywords, PubMed search strategies and in the creation of databases of references. Results and conclusions The critical analysis of the OVs and their MMs was performed on the basis of the literature review and was aimed at defining the appropriateness of OVs and MMs in the context each specific claimed effect. Clinical significance The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for Health Claims related to oral Health, as well as to the stakeholders for the identification of existing and design of novel randomized controlled trials aimed at substantiating such Health Claims.
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claimed effects outcome variables and methods of measurement for Health Claims proposed under european community regulation 1924 2006 in the area of blood glucose and insulin concentrations
Acta Diabetologica, 2018Co-Authors: Daniela Martini, Beatrice Biasini, Giorgio Bedogni, I Zavaroni, Carlo Pruneti, Marco Ventura, Daniela Galli, M Musci, Giovanni Passeri, Prisco MirandolaAbstract:Most requests for authorization to bear Health Claims under Articles 13(5) and 14 related to blood glucose and insulin concentration/regulation presented to the European Food Safety Authority (EFSA) receive a negative opinion. Reasons for such decisions are mainly ascribable to poor substantiation of the claimed effects. In this scenario, a project was carried out aiming at critically analysing the outcome variables (OVs) and methods of measurement (MMs) to be used to substantiate Health Claims, with the final purpose to improve the quality of applications provided by stakeholders to EFSA. This manuscript provides a position statement of the experts involved in the project, reporting the results of an investigation aimed to collect, collate and critically analyse the information relevant to claimed effects (CEs), OVs and MMs related to blood glucose and insulin levels and homoeostasis compliant with Regulation 1924/2006. The critical analysis of OVs and MMs was performed with the aid of the pertinent scientific literature and was aimed at defining their appropriateness (alone or in combination with others) to support a specific CE. The results can be used to properly select OVs and MMs in a randomized controlled trial, for an effective substantiation of the Claims, using the reference method(s) whenever available. Moreover, results can help EFSA in updating the guidance for the scientific requirements of Health Claims.
