Study protocol of a clinical randomized controlled trial on the efficacy of an innovative Digital thErapy to proMote wEighT loss in patients with obesity by incReasing their Adherence to treatment: the DEMETRA study.

Despite the increasing importance of innovative medications and bariatric surgery for the treatment of obesity, lifestyle interventions (diet and physical activity) remain the first-line therapy for this disease. The use of digital devices in healthcare aims to respond to the patient's needs, in order to make obesity treatment more accessible, so our study aims to assess the safety and efficacy of a Digital Therapy for Obesity App (DTxO) for achieving weight loss and its maintenance in patients affected with obesity undergoing an experimental non-pharmacological treatment. Here we present the study protocol of a prospective, multicenter, pragmatic, randomized, double-arm, placebo-controlled, parallel, single-blind study on obese patients who will be treated with a new digital therapy to obtain an improvement in their disease condition through the application of different simultaneous strategies (a dietary regimen and personalized advice program, a tailored physical exercise program, a cognitive-behavioural assessment and program, alerts and reminders, dedicated section on prescribed drugs intake, and chat and online visits with clinical professionals). We believe that DTxO will offer a promising intervention channel and self-regulation tool holding the potentiality to decrease treatment burden and treat more patients thanks to the partial replacement of traditional medical consultation with digital or telephone management, improving self- engagement and reducing the high demands the "obesity pandemic" for both patients and national health services in terms of time, cost, and effort. Clinical trial registration: clinicaltrials.gov, identifier, NCT05394779.

Sex Differences in the Relationship between Chronotype and Eating Behaviour: A Focus on Binge Eating and Food Addiction.

BACKGROUND: Men are more likely than women to have subthreshold overeating disorders. Lifestyle plays a role as a determinant, while chronotype is an emerging factor. Chronotype explains the natural preferences of wakefulness and activity throughout the day: evening chronotypes (E-Types), those most productive in the evening, have been linked with unhealthy dietary patterns and a higher propensity to substance addiction than morning types (M-Types). METHODS: We carried out a cross-sectional study on 750 overweight or obese adults (70% females, 48 ± 10 years, BMI 31.7 ± 5.8 kg/m2). The Binge-Eating Scale, the Yale Food Addiction Scale 2.0 (YFAS 2.0), the reduced Morningness-Eveningness Questionnaire (rMEQ), and the MEDAS questionnaire were used to assess binge eating, food addiction, chronotype, and adherence to the Mediterranean diet, respectively. RESULTS: No differences in BES binge-eating and FA food-addiction scores occurred between chronotypes, but we found significant interactions between sex × rMEQ score. While women showed the same prevalence for binge eating and food addiction across all chronotypes, binge eating and food addiction risk increased with reducing rMEQ score in men, indicating that being male and E-Type increases the risk association of binge eating and/or food addiction prevalence. CONCLUSIONS: chronotype is associated with binge eating and food addiction in men, emphasizing the link between chronobiology and sex differences as determinants in appetite and eating behaviour dysregulation and in overweight and obesity.

Impact of 4-week of a restricted Mediterranean diet on taste perception, anthropometric, and blood parameters in subjects with severe obesity.

Introduction: The study of taste functionality and its relation to human health is receiving growing attention. Obesity has been reported to cause alterations in sensory perception regarding system functionality and preferences. However, a small body of research addresses tastes perception and its modification with the achievement of body mass reduction through surgical intervention. Much fewer efforts have been made to evaluate the impact of mild restrictive nutritional intervention on gustatory functions. Thus, the objectives of this study were to determine if a dietary intervention of 4 weeks following a restricted balanced Mediterranean diet would affect the sweet and salty taste thresholds of subjects with severe obesity and could influence their anthropometric and blood parameters. Methods: Fifty-one patients with severe obesity (F: 31; age: 43.7 ± 12.5; BMI = 47.6 ± 1.0) were enrolled in the study. The recognition threshold for sweet and salty taste and anthropometric and blood parameters were assessed before and after the 4-week weight loss program. Results and Discussion: The Mediterranean diet has proven to be an effective treatment, significantly improving all anthropometric and blood parameters (p < 0.05) after 4 weeks of intervention. Moreover, the hypo-sodium treatment associated with the diet significantly improved the salty threshold (p < 0.001). No changes were detected for the sweet threshold. Collectively, these data highlight that dietary treatment might impact taste perception differently. Therefore, a taste-oriented nutritional intervention could represent a novel approach to developing more individualized, taste-oriented follow-up interventions to maintain sustainable and long-term weight loss.

Development of a questionnaire on nutritional knowledge for the obese hospitalized patient: the NUTRIKOB questionnaire.

Introduction: Different approaches, involving different areas and figures, are useful for the rehabilitation of obese subjects through a multidisciplinary hospital path. A focal point of rehabilitation is represented by education on healthy eating by increasing the dietary knowledge patients. Few tools investigating food knowledge are available in Italy: therefore, the need has emerged to develop easy-to-use tools for clinical practice that allow to detect food knowledge to set up a more targeted food re-education. The following work aimed at building and validating a questionnaire capable of investigating the dietary knowledge of the population affected by obesity. Methods: A pool of experts carried out a review of the literature, gathering all the information necessary to select and construct the best set of questions and the format of the final project of the questionnaire. During statistical analysis the validity, reproducibility and stability of the questionnaire were investigate in a sample of 450 subjects with obesity. Results: Early analysis disclosed that 5 questions of the original questionnaire had no discriminating power. The successive validation phases were successful, confirming good content validity, stability and reproducibility over time. Discussion: The questionnaire has all the characteristics to be considered a valid tool for investigating dietary knowledge in the obese population. The psychometric tests confirmed a good internal consistency of the structure, a validity of the content, a good reproducibility and stability over time.

Ultra-Processed Food Consumption and Incidence of Obesity and Cardiometabolic Risk Factors in Adults: A Systematic Review of Prospective Studies.

Ultra-processed foods (UPF) are energy-dense, nutritionally unbalanced products, low in fiber but high in saturated fat, salt, and sugar. Recently, UPF consumption has increased likewise the incidence of obesity and cardiometabolic diseases. To highlight a possible relationship, we conducted a systematic review of prospective studies from PubMed and Web of Science investigating the association between UPF consumption and the incidence of obesity and cardiometabolic risk factors. Seventeen studies were selected. Eight evaluated the incidence of general and abdominal obesity, one the incidence of impaired fasting blood glucose, four the incidence of diabetes, two the incidence of dyslipidemia, and only one the incidence of metabolic syndrome. Studies' quality was assessed according to the Critical Appraisal Checklist for cohort studies proposed by the Joanna Briggs Institute. Substantial agreement emerged among the studies in defining UPF consumption as being associated with the incident risk of general and abdominal obesity. More limited was the evidence on cardiometabolic risk. Nevertheless, most studies reported that UPF consumption as being associated with an increased risk of hypertension, diabetes, and dyslipidemia. In conclusion, evidence supports the existence of a relationship between UPF consumption and the incidence of obesity and cardiometabolic risk. However, further longitudinal studies considering diet quality and changes over time are needed.

Systematic Review on the Potential Effect of Berry Intake in the Cognitive Functions of Healthy People.

The increase in life expectancy poses health challenges, such as increasing the impairment of cognitive functions. Berries show a neuroprotective effect thanks to flavonoids, able to reduce neuroinflammatory and to increase neuronal connections. The aim of this systematic review is to explore the impact of berries supplementation on cognitive function in healthy adults and the elderly. Twelve studies were included for a total of 399 participants, aged 18-81 years (mean age: 41.8 ± 4.7 years). Six studies involved young adults (23.9 ± 3.7 years), and four studies involved the elderly (60.6 ± 6.4 years). Most studies investigated effects of a single berry product, but one used a mixture of 4 berries. Non-significant differences were detected across cognition domains and methodologies, but significant and positive effects were found for all cognitive domains (attention and concentration, executive functioning, memory, motor skills and construction, and processing speed), and in most cases they were present in more than one study and detected using different methodologies. Although some limitations should be taken into account to explain these results, the positive findings across studies and methodologies elicit further studies on this topic, to endorse the consumption of berries in healthy populations to prevent cognitive decline.

Changes in smell and taste perception related to COVID-19 infection: a case-control study.

The main aim of the present study was to psychophysically evaluate smell and taste functions in hospitalized COVID-19 patients and to compare those results with a group of healthy subjects. Another aim of the study was to assess the relationship of changes in patients' smell and taste functions with a number of clinical parameters, symptoms, and other physiological signs as well as with severity of disease. Olfactory and gustatory functions were tested in 61 hospitalized patients positive for SARS-CoV-2 infection and in a control group of 54 healthy individuals. Overall, we found a significant impairment of olfactory and gustatory functions in COVID-19 patients compared with the control group. Indeed, about 45% of patients self-reported complaints about or loss of either olfactory or gustatory functions. These results were confirmed by psychophysical testing, which showed a significantly reduced performance in terms of intensity perception and identification ability for both taste and smell functions in COVID-19 patients. Furthermore, gustatory and olfactory impairments tended to be more evident in male patients suffering from more severe respiratory failure (i.e., pneumonia with need of respiratory support need during hospitalization).

Ultra-processed foods and obesity and adiposity parameters among children and adolescents: a systematic review.

PURPOSE: According to the NOVA classification, ultra-processed foods are products made through physical, biological and chemical processes and typically with multiple ingredients and additives, in which whole foods are mostly or entirely absent. From a nutritional point of view, they are typically energy-dense foods high in fat, sugar, and salt and low in fiber. The association between the consumption of ultra-processed food and obesity and adiposity measurements has been established in adults. However, the situation remains unclear in children and adolescents. METHODS: We carried out a systematic review, in which we summarize observational studies investigating the association between the consumption of ultra-processed food, as defined by NOVA classification, and obesity and adiposity parameters among children and adolescents. A literature search was performed using PUBMED and Web of Science databases for relevant articles published prior to May 2021. RESULTS: Ten studies, five longitudinal and five cross-sectional, mainly conducted in Brazil, were included in this review. Four longitudinal studies in children with a follow-up longer than 4 years found a positive association between the consumption of ultra-processed food and obesity and adiposity parameters, whereas cross-sectional studies failed to find an association. CONCLUSION: These data suggest that a consistent intake of ultra-processed foods over time is needed to impact nutritional status and body composition of children and adolescents. Further well-designed prospective studies worldwide are needed to confirm these findings considering country-related differences in dietary habits and food production technologies.

Patients with Severe Obesity during the COVID-19 Pandemic: How to Maintain an Adequate Multidisciplinary Nutritional Rehabilitation Program?

BACKGROUND: The COVID-19 pandemic is spreading all over the world, particularly in developed countries where obesity is also widespread. There is a high frequency of increased BMI in patients admitted to intensive care for SARS-CoV-2 infection with a major severity in patients with an excess of visceral adiposity. Patients at risk of severe SARS-CoV-2 acute respiratory syndrome are characterised by the high prevalence of pre-existing diseases (high blood pressure and cardiovascular disease, diabetes, chronic respiratory disease, or cancer), most of them typically present in severely obese patients. Indeed, the biological role of adipose tissue in sustaining SARS-CoV-2 infection is not completely elucidated. SUMMARY: The forced isolation due to pandemic containment measures abruptly interrupted the rehabilitation programs to which many patients with severe obesity were enrolled. People affected by obesity, and especially those with severe obesity, should continue clinical rehabilitation programs, taking extra measures to avoid COVID-19 infection and reinforcing the adoption of preventive procedures. In this review, the available data on obesity and COVID-19 are discussed along with evidence-based strategies for maintaining the necessary continuous rehabilitation programs. Key Messages: Greater attention is needed for obese and severely obese patients in the face of the current COVID-19 pandemic, which represents a huge challenge for both patients and healthcare professionals. The adoption of new strategies to guarantee adequate and continuous multidisciplinary nutritional rehabilitation programs will be crucial to control the severity of SARS-CoV-2 infection in high-risk populations as well as the worsening of obesity-linked complications. Health authorities should be urged to equip hospitals with tools for the diffusion of telemedicine to maintain physician-patient communication, which is fundamental in chronic and complicated obese patients.