D Martini1, S Rossi1, B Biasini1, I Zavaroni2, G Bedogni3, M Musci4, C Pruneti5, G Passeri6, M Ventura7, S Di Nuzzo8, D Galli9, P Mirandola9, M Vitale9, A Dei Cas2, R C Bonadonna2, D Del Rio10. 1. The Laboratory of Phytochemicals in Physiology, Department of Food and Drug, University of Parma, Parma, Italy. 2. Department of Medicine and Surgery, Division of Endocrinology, University of Parma, Italy; Azienda Ospedaliera Universitaria of Parma, Parma, Italy. 3. Clinical Epidemiology Unit, Liver Research Center, Basovizza, Trieste, Italy. 4. Department of Food and Drug, University of Parma, Parma, Italy. 5. Department of Medicine and Surgery, Clinical Psychology Unit, University of Parma, Medical School Building, Parma, Italy. 6. Department of Medicine and Surgery, Building Clinica Medica Generale, University of Parma, Parma, Italy. 7. Department of Chemistry, Life Sciences and Environmental Sustainability, Laboratory of Probiogenomics, University of Parma, Parma, Italy. 8. Department of Medicine and Surgery, Section of Dermatology, University of Parma, Parma, Italy. 9. Department of Medicine and Surgery, Sport and Exercise Medicine Centre (SEM), University of Parma, Parma, Italy. 10. The Laboratory of Phytochemicals in Physiology, Department of Food and Drug, University of Parma, Parma, Italy. Electronic address: daniele.delrio@unipr.it.
Abstract
BACKGROUND AND AIMS: The high number of negative opinions from the European Food Safety Authority (EFSA) to the requests for authorization of health claims is largely due 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 to collect, collate and critically analyse the information in relation to claimed effects, OVs and MMs, in the context of protection against oxidative damage and cardiovascular health compliant with Regulation 1924/2006. METHODS AND RESULTS: Claimed effects, OVs and the related MMs were collected from EFSA Guidance documents and applications for authorization of health claims under Articles 13.5 and 14. The OVs and their MMs were evaluated only if the claimed effect was sufficiently defined and was considered beneficial by EFSA. The collection, collation and critical analysis of the relevant scientific literature consisted in the definition of the keywords, the PubMed search strategies and the creation of databases of references. 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 of the specific claimed effects. CONCLUSIONS: The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims, as well as to the stakeholders for the proper design of human intervention studies aimed to substantiate such health claims.
BACKGROUND AND AIMS: The high number of negative opinions from the European Food Safety Authority (EFSA) to the requests for authorization of health claims is largely due 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 to collect, collate and critically analyse the information in relation to claimed effects, OVs and MMs, in the context of protection against oxidative damage and cardiovascular health compliant with Regulation 1924/2006. METHODS AND RESULTS: Claimed effects, OVs and the related MMs were collected from EFSA Guidance documents and applications for authorization of health claims under Articles 13.5 and 14. The OVs and their MMs were evaluated only if the claimed effect was sufficiently defined and was considered beneficial by EFSA. The collection, collation and critical analysis of the relevant scientific literature consisted in the definition of the keywords, the PubMed search strategies and the creation of databases of references. 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 of the specific claimed effects. CONCLUSIONS: The information provided in this document could serve to EFSA for the development of further guidance on the scientific requirements for health claims, as well as to the stakeholders for the proper design of human intervention studies aimed to substantiate such health claims.
Authors: L Kirsty Pourshahidi; Eduardo Caballero; Alejandro Osses; Barry W Hyland; Nigel G Ternan; Chris I R Gill Journal: Eur J Nutr Date: 2020-01-09 Impact factor: 5.614
Authors: Daniela Martini; Donato Angelino; Chiara Cortelazzi; Ivana Zavaroni; Giorgio Bedogni; Marilena Musci; Carlo Pruneti; Giovanni Passeri; Marco Ventura; Daniela Galli; Prisco Mirandola; Marco Vitale; Alessandra Dei Cas; Riccardo C Bonadonna; Sergio Di Nuzzo; Maria Beatrice De Felici; Daniele Del Rio Journal: Nutrients Date: 2017-12-22 Impact factor: 5.717
Authors: Daniela Martini; Augusto Innocenti; Chiara Cosentino; Giorgio Bedogni; Donato Angelino; Beatrice Biasini; Ivana Zavaroni; Marco Ventura; Daniela Galli; Prisco Mirandola; Marco Vitale; Alessandra Dei Cas; Riccardo C Bonadonna; Giovanni Passeri; Carlo Pruneti; Daniele Del Rio Journal: Nutrients Date: 2018-02-14 Impact factor: 5.717