Claimed effects, outcome variables and methods of measurement for health claims proposed under European Community Regulation 1924/2006 in the framework of protection against oxidative damage and cardiovascular health.
Nutr Metab Cardiovasc Dis
; 27(6): 473-503, 2017 Jun.
Article
in En
| MEDLINE
| ID: mdl-28434807
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 ANDRESULTS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cardiovascular Diseases
/
Oxidative Stress
/
Functional Food
/
Food Safety
/
Antioxidants
Type of study:
Diagnostic_studies
/
Etiology_studies
/
Risk_factors_studies
Aspects:
Patient_preference
Limits:
Humans
Country/Region as subject:
Europa
Language:
En
Journal:
Nutr Metab Cardiovasc Dis
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
/
CIENCIAS DA NUTRICAO
/
METABOLISMO
Year:
2017
Document type:
Article
Affiliation country:
Italia