Funded under the National Recovery and Resilience Plan (NRRP), Mission 4 Component 2 Investment 1.3, Theme 10.
Funded under the National Recovery and Resilience Plan (NRRP), Mission 4 Component 2 Investment 1.3, Theme 10.
New therapeutic approach against obesity and metabolic diseases
Highlights
Coordinator
Profiling of vulnerable targets (in connection with SPOKE 5) through: a) analyses of existing data in children affected by obesity and ageing population at risk of malnutrition and non-communicable diseases (NCDs) b) screening of socioeconomic factors, lifestyle and dietary habits, environmental factors, food knowledge, nutritional status, body composition, functional status and disability, quality of life, genetic, metagenetic, phenotypic profiles, exposure to endocrine disruptors chemicals (EDCs), immune system functions in children and aging population with malnutrition c) human-derived biological samples analysis (including samples for the gut microbiome structure analysis and function).
Identification and application of biomarkers of malnutrition (including inflammatory, metabolic, microbiological, genetic and epigenetic ones) and biochemical pathways associated with diet and age-related diseases/ syndromes for early malnutrition detection and quality of life restoration in target specific categories.
Development and application of in vitro, in vivo and in silico experimental models for the understanding of the mechanism of action in counteracting malnutrition of new sustainable bioactive molecules from different matrices (in connection with Spoke 2, 3 and 4).
Investigation of the preventive and therapeutic action of sustainable personalised nutrition and microbial-derived products on malnutrition-associated gut microbiome alteration and effect on specific targets with malnutrition.
Implementation of sustainable dietary patterns as nutritional treatment for target specific groups with malnutrition. The task includes the prototyping of foods, supplements, ingredients and nutraceuticals aimed at restoring resilience in specific targets with malnutrition (in connection with Spoke 4). In addition, it is implemented a friendly end user personalised web responsive application for remote promoting and monitoring of sustainable dietary patterns target specific.
Preclinical and clinical evaluation of new prototypes of functional foods, food supplements, ingredients and nutraceuticals for preventing and treating malnutrition (in connection with Spoke 4).
Identification and mapping of specific target groups with malnutrition (M24)
Creation of a biobank for biological samples in connection with Spoke 5 (M36)
New biomarkers of malnutrition specific for diseases and age and related to diet (M24)
Identification of at least 7 sustainable bioactive molecules: a) 3 proven to directly impact nutritional status b) 2 proven to impact gut satiety hormones release c) 2 proven to reduce skeletal muscle mass decline in elderly populations with specific pathologies and/or nutritional impairments (M24)
Profiling of gut bacterial constituents with potential applications as postbiotics aimed at restoring immune system and metabolic functions in vulnerable subjects with malnutrition (M36)
Development and validation of new sustainable nutritional protocols for specific target groups with malnutrition (M36)
New prototypes of functional foods, food supplements, ingredients and nutraceuticals for malnutrition and malnutrition related diseases (n=5) (M36)
Proof of concept (M12)
Scaling up of innovative functional foods, food supplements, ingredients and nutraceuticals useful coadjuvant for malnutrition treatment (M30)
The main form of malnutrition of industrialized countries is obesity, the main risk factor for metabolic complications and comorbidities, including metabolic syndrome and type 2 diabetes.
Effective therapeutic strategies are needed to limit the disease burden.
This project will be developed in pediatric patients (1) and adult patients (2 and 3) affected by obesity.
1) The “Butyrate Against Pediatric Obesity II trial” (BAPO II trial) has been designed to evaluate whether supplementation with a new butyrate releaser can be effective in pediatric obesity treatment.
2) The “Exploring individual determinants of postpranDIAl glycemic response in type 2 diaBEteS to opTimize therapeutic strategies with a personalized approach (DIABEST)” to individuate intra and interindividual determinants of postprandial glucose response.
3) A nutritional intervention has been designed to evaluate whether a drink containing 1.5 g of polyphenols from red grape pomace can be effective in the modulation of metabolic parameters, inflammation, liver fat, in individuals with type 2 diabetes.
1) It will be enrolled at least n=54 patients with obesity, of both sexes, aged 5-17 years. Patients will be randomly allocated to receive the standard care for pediatric obesity plus butyrate releaser or placebo for 6 months.
The following variables will be collected:
2) It will be enrolled at least n=100 patients affected by type 2 diabetes of both sexes, aged between 18-65 years observed at the Department of Clinical and Surgery Medicine at the University Federico II.
3) Forty patients with type 2 diabetes will be randomly allocated to receive a daily serving of an experimental drink containing 1.5 g of polyphenols from red grape pomace or a placebo drink. The following variables will be evaluated at the end of each intervention: liver steatosis, glycemic parameters.
The results of these studies will allow the development of a new functional food deriving from eco-sustainable sources useful in the management of obesity and metabolic diseases. These studies will provide data of high clinical relevance, paving the way to innovative strategies for counteracting obesity and metabolic alterations with huge beneficial impact for the patients, their families and the Italian Healthcare System. These new therapeutic approach could be innovative and sustainable strategies for their feasibility and cost-saving nature.
