Carlo Pruneti

Motor events during REM sleep in patients with narcolepsy–cataplexy: A video-polysomnographic pilot study

OBJECTIVE We carried out a systematic video-polysomnographic analysis of the number and type of motor events during REM sleep in narcolepsy-cataplexy patients with REM sleep behavior disorder (NC + RBD) but not clinical RBD (NC-RBD). METHODS Twelve NC + RBD and 10 NC-RBD male patients underwent video-polysomnography (video-PSG). Motor events of different type and complexity (i.e., elementary and complex movements and vocalizations) occurring during REM sleep were visually assessed, and indices of their frequency per hour of REM sleep were calculated. Subsequently, the index values were compared in NC + RBD versus NC-RBD patients. RESULTS Typical RBD behaviors observed in five NC + RBD patients were not included in any type of motor events. No objective conventional sleep parameter, including visual analysis of chin electromyographic (EMG) activity, significantly differed between the two groups of NC patients. NC + RBD patients showed higher occurrence of elementary movements (p = 0.034) during REM sleep compared with NC-RBD patients, but the occurrence of complex movements did not differ significantly. CONCLUSIONS Video-analysis of motor events during REM sleep may improve the diagnosis of RBD in NC. RBD in NC patients is mainly characterized by elementary rather than complex movements, consistent with the view that RBD with NC patients displays a distinct phenotype with respect to other RBD patients.

Depressive Symptoms and Academic Self-Image in Adolescence

The aim of this paper was to specifically analyse the relationship between the different components of academic self-image, defined as the way adolescents represent themselves as students, and self-reported depressive symptoms, assessed with the Children’s Depression Inventory (CDI), in a non-clinical sample of 298 adolescents. We considered both adolescents’ beliefs about their own cognitive functioning in academic performance and beliefs about their emotional attitude in achievement situations. Our data indicate that the pattern of correlation between emotional beliefs about schooling and learning are significantly related to CDI scores, but this correlation is not evident for the cognitive beliefs. This pattern of correlation is affected by actual school functioning, because correlation between CDI and beliefs is much more significant in subjects without school failure. Differences between gender in CDI scores, beliefs about schooling and learning, and pattern of correlation are considered. These results can enable to focus supporting psychological interventions on more specific targets.

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

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.

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

Abstract 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.

Differences in the Visual Motor Development in Children: A Cross-Cultural Study

Since existing data on school frequently show disparity between indigenous and non-native students in academic achievement this research aims to face this problem monitoring objective and measurable differences between these groups in a cross cultural perspective. 177 children from different schools in Parma and La Spezia were recruited. The sample was divided into three subgroups: Italians; Italians with foreign parents; Immigrants. Children completed the performance test Bender Visual Motor Gestalt Test. The “cultural context” seems to influence the results in the BVMGT. Results suggest that immigrants are grown in contexts culturally less stimulating visual-perceptual abilities and being unable to attend preschool and primary education in this country, may have affected their performance at the test. The comparison between Italians and Italians* is not significant: children born and grown in the same cultural context faced a similar training path. Regardless of intelligence or other individual characteristics, not all components of a multicultural classroom stem from the same level of skills and competencies. A simple test such as the Bender can become a useful predictive tool to identify gaps and differences between people from different cultures in order to create focused interventions

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims Proposed Under European Community Regulation 1924/2006 in the Framework of Maintenance of Skin Function

Evidence suggests a protective role for several nutrients and foods in the maintenance of skin function. Nevertheless, all the requests for authorization to use health claims under Article 13(5) in the framework of maintenance of skin function presented to the European Food Safety Authority (EFSA) have received a negative opinion. Reasons for such failures are mainly due to an insufficient substantiation of the claimed effects, including the choice of inappropriate outcome variables (OVs) and methods of measurement (MMs). The present paper reports the results of an investigation aimed at collecting, collating and critically analyzing the information with relation to claimed effects (CEs), OVs and MMs related to skin health compliance with Regulation 1924/2006. CEs, OVs and MMs were collected from both the EFSA Guidance document and from the authorization requests of health claims under Article 13(5). The critical analysis of OVs and MMs was based on a literature review, and was aimed at defining their appropriateness (alone or in combination with others) in the context of a specific CE. The results highlight the importance of an adequate choice of OVs and MMs for an effective substantiation of the claims.

The Role of Nutrients in a Dietary Intervention in Improving Blood Cholesterol Profile and Lowering Cardiovascular Risk

Low-density lipoprotein cholesterol has been positively associated to an increase of cardiovascular risk by a large number of epidemiological studies. On the contrary, high-density lipoprotein cholesterol results inversely related to cardiovascular risk. In this contest plasma total cholesterol and low-density lipoprotein cholesterol concentration, and the total cholesterol - high-density lipoprotein cholesterol ratio seems to be able to predict cardiovascular risk. Diet and its composition affects various plasma cholesterol concentration and their ratios. Particularly, a reduction of saturated fat acids dietary intake is strictly related to both improve of blood lipid profile and reduction of cardiovascular events incidence. On the other hand, the evidences from epidemiologic and clinical studies are consistent in finding that the reduction of cardiovascular risk depends by nutrients used for replacing saturated fat acids. Specifically it has been demonstrated that replacement of saturated fat acids with unsaturated fat acids, either monounsaturated or polyunsaturated ones, is effective in improving cardiovascular risk. On the contrary, saturated fat acids replacement with high glycemic index refined carbohydrate actually increases cardiovascular risk. Despite that, many dietary guidelines do not give any tips about nutrients to use in replacement of saturated fat acids, underestimating the significance. In this perspective Mediterranean diet, represents an attractive dietary pattern for the improvement of blood lipid profile and the reduction of the cardiovascular risk.

Claimed Effects, Outcome Variables and Methods of Measurement for Health Claims on Foods Related to Vision Proposed Under Regulation (EC) 1924/2006

Adequate visual function has a strong impact on the quality of life of people. Several foods and food components have been hypothesized to play a role in the maintenance of normal visual function and in the prevention of eye diseases. Some of these foods/food components have been the object of a request of authorization for use of health claims under Articles 13(5) or 14 of the Regulation (EC) 1924/2006. Most of these requests have received a negative opinion from the European Food Safety Authority (EFSA) due to the choice of inappropriate outcome variables (OVs) and/or methods of measurement (MMs) applied in the studies used to substantiate the claims. This manuscript refers to the collection, collation and critical analysis of OVs and MMs related to vision. Guidance document and requests for authorization of health claims were used to collect OVs and MMs related to vision. A literature review was performed to critically analyse OVs and MMs, with the aim of defining their appropriateness in the context of a specific claimed effect related to vision. The results highlight the importance of adequate choices of OVs and MMs for an effective substantiation of claims related to visual function.

Claimed effects, outcome variables and methods of measurement for health claims on foods related to the gastrointestinal tract proposed under regulation (EC) 1924/2006

Abstract Most of the requests of authorisation to the use of health claims pursuant to Regulation EC 1924/2006 related to the gastrointestinal (GI) tract have received a negative opinion by the European Food Safety Authority (EFSA), mainly because of an insufficient substantiation of the claimed effect (CE). The present manuscript refers to the collection, collation and critical analysis of outcome variables (OVs) and methods of measurement (MMs) related to the GI tract compliant with Regulation 1924/2006. The critical evaluation of OVs and MMs was based on the literature review, with the final aim of defining their appropriateness in the context of a specific CE. The results obtained are relevant for the choice of the best OVs and MMs to be used in randomised controlled trials aimed to substantiate the claims on the GI tract. Moreover, the results can be used by EFSA for updating the guidance for the scientific requirements of such health claims. Graphical Abstract

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

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.