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Objective: This preliminary study aims at investigating the neural correlates of the stress response, intended as an emotional and cognitive response, through the description of the activation of the autonomic nervous system in a problem-solving task and central functional data; in particular, we recorded skin conductance level (SCL) and response (SCR) and observed the correlation with fMRI data. Materials and methods: The results obtained from 6 healthy subjects, 3 males and 3 females, aged between 18 and 45 (average = 27, SD = 7.08) who voluntarily offered to participate in the study were examined. They were previously subjected to a brief clinical psychological assessment (MMPI-2) and then to a psychophysiological evaluation. The real experiment consisted in subjecting the participants to an adapted version of the Raven's Coloured Progressive Matrices 47 (CPM 47) test to evaluate some consequences on brain activity of attention, orientation, reflex and response to stress during fMRI data acquisition and SCL-SCR recording. Results: SCR changes were found to be related to the activity of different brain regions such as bilateral precentral gyrus, right inferior frontal gyrus, right medial frontal gyrus, bilateral superior frontal gyri and left anterior cingulate suggesting a specific relationship between attentive processing and autonomic arousal. Conclusion: The association of SC measurement with neuroimaging allows to highlight the interaction between emotional and cognitive processes: although preliminary, these results partially confirm what previously found in literature on the neural correlates of psychological stress and underline the interaction between cognitive function and autonomic arousal system during a stressful problem-solving task. [ABSTRACT FROM AUTHOR]

Objective: The literature on clinical psychophysiology highlights the possibility of using Heart Rate Variability (HRV) as an index of psychophysical balance and resilience to stress. This study investigates the differences in stress reactivity and subsequent recovery between a group of migraineurs and healthy controls., Methods: Socio-demographic (i.e., sex, age, profession, marital status, and level of education) and psychophysiological (HR and HRV) measures of a group of thirty subjects with migraine (26 migraineurs without aura (86.7%), 2 migraineurs with aura (6.7%), and 2 migraineurs with and without aura (6.7%)) and from thirty healthy control subjects were collected. In particular, HRV was analyzed through frequency-domain parameters, including Low-Frequency (LF; 0.04-0.15 Hz) and High-Frequency (HF; 0.15-0.4 Hz) bands as well as LF/HF ratio during a Psychophysiological Stress Profile (PSP) structured in seven phases: (1) Baseline, (2) Objective stressor 1 (Stroop Test), (3) Rest 1, (4) Objective stressor 2 (Mental Arithmetic Task), (5) Rest 2, (6) Subjective stressor (recount a significant life event), and (7) Rest 3. The LF, HF, and LF/HF ratio values were transformed into a logarithmic scale (i.e., log-LF, log-HF, and log LF/HF ratio). Additionally, LF and HF were converted into normalized units (0-100) (i.e., LF% and HF%) which, in turn, were used to obtain reactivity and recovery to stress through delta values (Δ) calculation., Results: Subjects with migraine reported greater ΔLF% levels of reactivity and recovery to subjective stressor, demonstrating a prevalence of sympathetic activity while recounting a personal life event. At the same time, a lowering of the same values was found in the subjects of the group control., Discussion: Our results underline the importance of conducting a psychophysiological assessment in patients with headaches because reduced stress management skills could influence the clinical manifestations of the disease, considering stress as one of the most common triggers for migraine patients., (© 2024. The Author(s).)

(1) Background: The literature regarding orthorexia nervosa (ON) has well documented the association with other mental disorders, such as obsessive-compulsive and eating disorders. However, the research has not taken into account stress-related behavior and the conduction of physical activity (PA), both structured and unstructured. (2) Methods: In this cross-sectional study, 165 students of the University of Parma (92 females and 74 males) aged between 18 and 49 years old (mean = 24.62 ± 4.81) were consecutively recruited. The ORTO-15 questionnaire was used to divide the total sample into a group without orthorexia (score > 40) and a group with orthorexia (score < 40). All subjects completed the P Stress Questionnaire, and specific items were extrapolated from the Eating Habits Structured Interview (EHSI) to investigate lifestyle, including structured and unstructured PA. (3) Results: Subjects with orthorexia represented 83% of the total sample and reported higher levels of stress-related risk behaviors (i.e., sense of responsibility (t = -1.99, p = 0.02), precision (t = -1.99, p = 0.03), stress disorders (t = -1.38, p = 0.05), reduced spare time (t = -1.97, p = 0.03), and hyperactivity (t = -1.68, p = 0.04)) and a higher frequency of PA (i.e., hours spent training in structured PA, daily (t = -1.68, p = 0.05), weekly (t = -1.91, p = 0.03), and monthly (t = -1.91, p = 0.03), the tendency to carry out physical exercise even if tired (t = -1.97, p = 0.02), and to adhere to unstructured PA (i.e., moving on foot or by bike rather than using transport (t = 1.27, p = 0.04)). (4) Conclusions: The results confirmed the presence of hyperactivity at a motor and behavioral level in people with orthorexia. Further studies are necessary to highlight the causality between ON, stress, and physical activity but it may be possible to hypothesize that "obsessive" physical exercise may not generate the benefits generally known by the literature.

Purpose: The aim of the current study was to investigate the relationship between state (i.e., hostility) and trait (i.e., social detachment, alexithymia) psychological constructs associated with suicidal ideation among university students., Methods: A group of 190 university students was consecutively recruited in the period between September 2022 and March 2023. After a clinical interview, a series of psychological tests were administered: the Cattell's 16-Personality Factors Questionnaire (16PF), the Toronto Alexithymia Scale (TAS-20), the Symptom Checklist-90-R (SCL-90-R), and the anamnestic form of the Cognitive Behavioral Assessment (CBA2.0), which contains a specific question regarding the suicidal ideation., Results: The analyses demonstrated that alexithymia fully mediated the relationship between a particular aspect of introversion (social detachment or low warmth) and hostility which, in turn, seemed to be a significant predictor of suicidal ideation., Conclusions: The path analysis conducted seemed to highlight the importance of personality traits, such as social detachment and the ability to recognize and express one's internal states, on the mental health of university students in terms of hostility and suicidal ideation. Considering that the reduction of suicide mortality has been prioritized as a global target in the 15-19 age group, identifying the psychological factors associated with it is fundamental., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

The objective of this research was to assess the efficacy of behavioral therapy interventions in the treatment of autism spectrum disorders (ASD). The study utilized the PubMed and Embase databases to locate randomized controlled trials, quasi-experimental treatment studies, and randomized clinical trial comparisons. The experimental group received treatment based on an applied behavioral approach, such as PECS, DTT, PRT, TEACCH, ESDM, and EIBI. After examining seventeen studies, the researchers found that each type of behavioral intervention had a positive impact. Naturalistic protocols that employed PRT and PECS improved ASD symptoms in general, despite their targeting of particular cognitive domains such as language. ESDM enhanced receptive language, particularly in preschool-aged children. Structured and integrated interventions, like EIBI and TEACCH, improved overall adaptive functioning. Combining DTT with a TEACCH program produced greater benefits in linguistic, affective-social, and personal autonomy domains. However, there is a scarcity of high-quality research available on behavioral interventions for ASD. Further comparative studies are necessary to identify cost-efficient interventions. For example, PRT and PECS significantly improved social communication skills in only 15-40 hours over six months. The authors emphasized the need for continued research and the application of evidence-based interventions in specialized settings., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: The interplay between physical and psychological symptoms frequently affects the health-related quality of life of asthma patients., Participants and Procedure: This research aimed at assessing the psychological status of 60 patients attending their first/second doctor visit at which they were diagnosed with allergic asthma. Information on psychological distress was collected through the Symptom Questionnaire (SQ), personality traits were described through Cattell's 16-Personality Factor Questionnaire (16-PF), stress-related behavior was detected through the P Stress Questionnaire (PSQ), and the perceived quality of life was described with the Rhinasthma questionnaire., Results: The SQ revealed anxiety levels above the clinical cut-off in 71.7% of patients, levels of depression in 46.7%, anger-hostility in 53.3%, and somatic symptoms in 65%. No significant differences were observed after three months. The 16-PF scores were also suggestive of specific personality traits associated with the predisposition towards psychosomatic disorders. However, no stress-related behaviors were observed with the PSQ. Rhinasthma highlighted a certain degree of the perceived quality of life. Additionally, the quality of life correlated with age, all psychological distress scales, a few personality traits, vigor, and stress disorders., Conclusions: Allergic asthma patients present a higher-than-average level of psychological distress and impaired perceived quality of life at the time of diagnosis. Therefore, it is important to assess the psychological status in addition to the respiratory function., Competing Interests: The authors declare no conflict of interest., (Copyright © Institute of Psychology, University of Gdansk.)

Background: Within the current literature concerning the gynecological surgery, there are only a few studies that focus on the psychological aspects that characterize the peri-operative period. In this research, the psychopathological symptoms and the illness behavior were assessed in order to confirm previous results about clinical variables such as the type and method of intervention, as well as psychological aspects regarding the positive anamnesis for mental disorders. Moreover, other factors including the desire for maternity and previous surgical interventions and pregnancies were also investigated., Methods: In this observational research, 58 women (age = 41.5 ± 8.8), that undergone gynecological surgery (conservative and non-conservative) for benign pathologies, were consecutively recruited. Information on psychopathological symptoms was collected 15 days (T0) and one day before surgery (T1), and at the time of discharge (T2) through the Symptom Questionnaire (SQ). At T2, the Illness Behavior Questionnaire (IBQ) was also administered., Results: The descriptive analyzes conducted on the total sample demonstrated that while anxious activation and irritable mood decrease from T0 to T1, somatizations and depression mood increase between T1 and T2. Moreover, the comparisons between groups, dividing the sample according to the clinical-medical and psychological variables, highlighted that the type and modality of the intervention, as well as a positive history for the presence of psychological disorders, the desire for maternity, and previous surgical interventions and pregnancies, can influence the course of psychopathological symptoms., Conclusion: This study highlights the need to include a clinical-psychological evaluation and to pay attention to specific clinical variables regarding women that are undergoing a conservative or non-conservative gynecological surgery. Considering the psychological impact of these type of interventions, the clinical history of these women, as well as their fears and desires, could facilitate a better management of the patients in terms of well-being, adherence to treatment, and recovery., Competing Interests: Conflict of interests: The authors have declared that there is no conflict of interest.

(1) Background : Depression is a serious health problem with a high cost for public administration. Epidemiological studies report that one in five children have a mental disorder and about 50% of mental health problems exacerbate in childhood and adolescence. Moreover, the antidepressant efficacy in children and adolescents is poorly demonstrated and can cause severe behavioral adverse events such as suicidal ideation. (2) Methods : This systematic literature review examined oral supplementations (Omega-3, fish oil, Vitamin D 3 ) to treat depressed children, preadolescents, and adolescents. MEDLINE, Scopus, Embase, and PsycInfo were searched for articles published in the last five years. Six studies met the eligibility criteria. The inclusion criteria encompassed children, preadolescents, and adolescents, a diagnosis of depression, and an intervention of oral supplementations such as Omega-3, fish oil, and Vitamin D 3 . (3) Results : Most of the studies demonstrated that dietary intervention provides positive outcomes in terms of depression symptoms. (4) Conclusions : Overall, the results demonstrate a positive effect for oral supplementation suggesting an increase intake of Omega-3, fish oil, and Vitamin D 3 . However, only a few studies assess the effectiveness of diet recommendations, as a monotherapy or combined treatment, for the management of depression at developmental ages. Thus, there is still a need to further investigate these aspects and to look more specifically at adolescents and preadolescents.

(1) Background: A new mental illness is attracting the attention of researchers and mental health professionals. Orthorexia nervosa (ON) is a possible new mental disorder, the main symptom of which is an obsessive and insecure focus on healthy foods and consequent compulsive behaviors. There is a common consensus among researchers that ON is considered partly overlapping with obsessive-compulsive disorders (OCDs). (2) Methods: MEDLINE and Scopus were searched for articles published in the last 10 years regarding the psychophysiological aspects of OCD and ON. Eight studies met the eligibility criteria. The inclusion criteria encompassed adults diagnosed with OCD and/or ON. However, only studies involving OCD patients were found. (3) Results: Some research groups have shown that OCD disorders can be considered among anxiety disorders because they are characterized by anxious hyper activation. Other research, however, has shown profiles characterized by low psychophysiological reactivity to stressful stimuli. Despite this, there seems to be a consensus on the poor inhibition abilities, even when activation is low, and the dissociation between cognitive and psychophysiological activation emerged. (4) Conclusions: However discordant, some points seem to bring the researchers to agreement. In fact, there is consensus on conducting a multidimensional assessment that can measure all of the aspects of suffering (cognition, emotion, and behavior) and highlight the poor body-mind integration. This clinical approach would make it possible to propose interventions aimed at treating some mental illnesses such as food obsession that can paradoxically impair the psychophysical balance. Nevertheless, the applied systematizing approach to existing studies on ON is very much needed for better understanding of the psychophysical nature of this new mental illness and its implications for prevention and treatment.

Background: The health-related quality of life (HRQoL) of people with hemophilia (PWH) is an important issue, especially considering people suffering from chronic diseases beyond hemophilia. The principal aim of this study was to investigate the presence and relevance of psychological symptoms, both internalizing and externalizing, lifestyle, and HRQoL in a group of Italian PWH with chronic bloodborne co-infections and comorbidities. Furthermore, the research describes the association between psychological aspects and the impact of disease-related characteristics (type of hemophilia, presence of co-infections, and comorbidities) on them., Methods: Seventy patients (mean age 46.77±11.3), 64 with severe hemophilia A (Factor VIII: C < 1 IU/dL) and 6 with severe hemophilia B (Factor IX <1 IU/dL), were consecutively recruited from seven Hemophilia Centers in Italy of Italian Association of Hemophilia Centers (AICE). In order to assess psychological symptoms, HRQoL, and lifestyle, three psychological questionnaires were administered (the SCL-90-R, SF-36, and PSQ, respectively)., Results: A general decline in the quality of life and an increase in the tendency to adopt a lifestyle characterized by hyperactivity emerged. Inverse correlations were found between HRQoL and psychological distress. Although the SCL-90-R did not reveal symptoms above the clinical cut-off, co-infections significantly increased anxiety, depression, somatizations, paranoia, and social withdrawal. Lastly, HRQoL is impaired by co-infections as well as comorbidities., Conclusion: Our preliminary results must be confirmed to deepen the findings between mental health and hemophilia., Competing Interests: Competing interests: The authors declare no conflict of Interest.

(1) Background: Functional Hypothalamic Amenorrhea (FHA) can be caused by the hyper activation of neuro-endocrine responses to stress. Among other endocrine factors and hypothalamic dysfunctions, the psychophysiological stress response can very frequently lead to an inhibition of the gonadal-pituitary axis. The aim of this study was to investigate the level of neurovegetative activation in a group of young women affected by this condition. (2) Methods: Twenty-five women (mean age = 21.1 ± 4.34) with FHA were consecutively recruited. Information on psycho-physiological distress was collected through a Psychopathological assessment (with the administration of three psychometric tests) and the Psychophysiological Stress Profile (PSP). Their data were compared with a control group. (3) Results: In the PSP, the patients displayed significantly higher values compared to controls in terms of the parameters of muscle tension (sEMG), skin conductance (SCL/SCR), heart rate (HR), and peripheral temperature (PT). Furthermore, autonomic hyper-activation at rest, marked reactivity to stress, and reduced recovery were seen. Moreover, a condition characterized by psychological distress (anxiety and somatic complaints, depressed and irritable mood, obsessive-compulsive traits) emerged. (4) Conclusions: The results highlight autonomic hyper-activation in FHA, which is also associated with psychological distress. Considering that FHA is a condition that affects multiple systems between mind and body, a multimodal, multidimensional, and multidisciplinary assessment of stress is becoming an emerging need., Competing Interests: The authors declare no conflict of interest.

Free- radicals (Oxygen and Nitrogen species) are formed in mitochondria during the oxidative phosphorylation. Their high reactivity, due to not-engaged electrons, leads to an increase of the oxidative stress. This condition affects above all the brain, that usually needs a large oxygen amount and in which there is the major possibility to accumulate "Reacting Species." Antioxidant molecules are fundamental in limiting free-radical damage, in particular in the central nervous system: the oxidative stress, in fact, seems to worsen the course of neurodegenerative diseases. The aim of this review is to sum up natural antioxidant molecules with the greatest neuroprotective properties against free radical genesis, understanding their relationship with the Central Nervous System., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Franzoni, Scarfò, Guidotti, Fusi, Asomov and Pruneti.)

Alzheimer's disease (AD) manifests with progressive memory loss and spatial disorientation. Neuropathological studies suggest early AD pathology in the entorhinal cortex (EC) of young adults at genetic risk for AD ( APOE ε4-carriers). Because the EC harbors grid cells, a likely neural substrate of path integration (PI), we examined PI performance in APOE ε4-carriers during a virtual navigation task. We report a selective impairment in APOE ε4-carriers specifically when recruitment of compensatory navigational strategies via supportive spatial cues was disabled. A separate fMRI study revealed that PI performance was associated with the strength of entorhinal grid-like representations when no compensatory strategies were available, suggesting grid cell dysfunction as a mechanistic explanation for PI deficits in APOE ε4-carriers. Furthermore, posterior cingulate/retrosplenial cortex was involved in the recruitment of compensatory navigational strategies via supportive spatial cues. Our results provide evidence for selective PI deficits in AD risk carriers, decades before potential disease onset., (Copyright © 2020 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works. Distributed under a Creative Commons Attribution License 4.0 (CC BY).)

Mild cognitive impairment (MCI) is a common feature in Parkinson's Disease (PD), even at the time of diagnosis. Some levels of heterogeneity in nature and severity of cognitive impairment and risk of conversion to Parkinson's Disease Dementia (PDD) exist. This brief overview summarized the current understanding of MCI in PD, by considering the following major points: historical development of the clinical entity, evaluation, epidemiology, predictors and outcomes, neuroimaging findings, pathophysiology, treatment, and pharmacological and non-pharmacological intervention. MCI in PD represents a concept in evolution and plays a pivotal role in advancing our understanding of the disease mechanisms, with the ultimate goal of building effective strategies to prevent conversion into PDD. Challenges for future research are also discussed., (Copyright © 2019 Cammisuli, Cammisuli, Fusi, Franzoni and Pruneti.)

The influences of physical and mental activity on cognitive functioning were examined in a sample of Italian healthy elderly males. The aim of the present study was to suggest aerobic training as well as cognitively stimulating activity and provide recommendations for an overall healthy lifestyle. Seventy-five healthy adult males, aged 65-81, were assigned to four groups, two groups of active subjects practicing different levels of regular aerobic exercise, and two groups of sedentary subjects, one without any relevant mental stimulating activity and the other one regularly carrying out substantial mental activity. Each group was further divided into three subgroups based on their level of education. Cognitive functioning was assessed by the Italian version of MoCA. Data was analysed in a non-parametric two-factor model by Aligned Rank Transformation, and then compared with the normative data for the Italian population. Physically active subjects showed better cognitive performance than the other groups in all the cognitive domains, except for memory and orientation. Among the sedentary subjects, the mentally active ones showed better performance in some cognitive domains, specifically in attention and memory. The influence of education was highlighted in some scores, but significant interactions with activity levels were never highlighted. Moreover, the influence of life habits (i.e. physical and mental activity) on the MoCa scores always showed a higher effect size than education. Our findings showed that both physical and mental activity improve cognitive functions in the elderly, and that they affect specific cognitive domains.

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.

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.

Background: Previous reviews and meta-analysis have shown that physical activity has positive effects on cognition in healthy elderly as well as in patients with Mild Cognitive Impairment, even if with a minor effect whereas less is known about the effectiveness of aerobic exercise in patients with Alzheimer's Disease (AD)., Objectives: The aim of the present study was to systematically review the evidence from randomized controlled trials (RCTs) designed to evaluate aerobic exercise effects upon cognition in AD patients., Methods: PubMed, Cochrane, Web of Science and DARE databases were analytically searched for RCTs including aerobic exercise interventions for AD patients., Results: There is scarce evidence that aerobic exercise improves cognition in AD patients. Overall, the included studies reported only positive effects for patients'global cognition after intervention, mainly due to a lack of accurate neuropsychological assessment of each cognitive domain. Whether the bene ts of exercise are evident in all stages of AD pathology remain also uncertain., Conclusions: Standardized protocols, larger and more rigorous RCTs with long-term follow-ups may provide better insight into the effects of aerobic exercise on cognitive deterioration characterizing people with AD.

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.

This study aimed to evaluate the psychological and physiological adjustment in a sample of Ovarian Cancer survivors. For all we know, this is the first time that such analysis has been performed in Italy. We assessed psychological adjustment along with physiological adjustment, measured through the basal Heart Rate Variability at rest. We assessed 38 women overall, aged 29-80 years, in follow up for ovarian cancer. Each participant filled a psycho-oncological record, Multidimensional Scale of Perceived Social Support, Derridford Appearance Scale-59, Mental Adjustment to Cancer and EORTC Quality of Life Questionnaire LQ-30 Version 3.0. For each participant, we recorded Heart Rate Variability (5 min). These women have shown a high rate of perceived general social support (Me = 5.93) but they seem to have some general concern about their appearance (Me = 85.97, SD = 24.4). They have also shown a rather good total Quality of Life (QL2 Me = 66.32) with specific difficulties in emotional functioning (EF; Me = 69.19). Heart Rate Variability values, however, were lower of nearly 50% when compared to normative values. These women, then, seem to drag concerns and difficulties, in particular linked to the acceptance of their condition. Surprisingly enough, the best adjustment in these women seems to be related to the worst starting conditions. It is possible to suggest that the extremely negative conditions force these women to face cancer openly, as well as their condition of cancer survivors, pushing them "moving on" more than "trying to get back".

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.

Background and Aim: Improving quality of life of patients with early Alzheimer's Disease (AD) is a primary concern of health professionals involved in dementia treatment. The aim of this study is to reveal associations among psychiatric symptoms and wellbeing aspects, dysfunctional lifestyles and stress-related behaviors, illness perception, personality traits, and life quality satisfaction, in order to offer a comprehensive evaluation of psychological and behavioral aspects characterizing patients with early AD., Methods: This is a cross-sectional study in which all the outpatients included were evaluated at the Dementia Clinic in Parma (Italy). 21 patients with probable AD were assessed by an overall cognitive screening (Milan Overall Dementia Assessment), the evaluation of personal and instrumental autonomy (Activities of Daily Living and Instrumental Activities of Daily Living), and of dementia severity (Clinical Dementia Rating Scale). After the neurocognitive assessment, a wide battery of clinical and psychological measures (Symptom Questionnaire, Pisa Stress Questionnaire, Illness Behavior Questionnaire, Sixteen Personality Factor Questionnaire and Satisfaction Profile) was administered to the patients. Spearman's rho correlations between clinical and psychological measures were performed., Results: A tendency to deny anxiety, depressive and somatic symptoms might be present in patients with early AD. They also present with hypochondriasis, resulting in higher level of anxiety and depression. Reduced liveliness and self-reliance as personality traits may influence the intensity of such symptoms., Conclusions: A comprehensive assessment including psychological and clinical measures should be routinely integrated in clinical practice for the evaluation of patients with early AD.

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., Competing Interests: The authors declare no conflict of interest.

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., Competing Interests: The authors declare no conflict of interest.