Beneficial Effects of Dietary and Lifestyle Change in Overweight and Obese Subjects

Study Overview
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Brief Summary
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Obesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults. In 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (WHO). In the EU-27 (Eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese. The growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes). A transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.

Detailed Description
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The study is aimed to measure the beneficial effects of specific dietary models (i.e., Mediterranean Diet) and healthy lifestyle (i.e., controlled physical activity) in reducing body/organ fat accumulation and in the improvement of metabolic health. A comprehensive and combined analysis of these effects (mainly following personalized strategies and close follow-up) on pathogenic mechanisms affecting cardiovascular and metabolic risk, pro-inflammatory status and intestinal permeability in the medium-long term is still lacking. During the study, overweight/obese subjects (i.e. Body Mass Index equal or higher to 25Kg/m2) will be assessed at basal and monitored during a 24 months follow-up

Official Title
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Effects of Personalized Dietary and Lifestyle Treatments on the Reduction of Cardiovascular and Metabolic Risk in Overweight and Obese Patients

Conditions
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Overweight and Obesity, Cardiovascular Diseases, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or obese patients patients who able to sign informed consent Exclusion Criteria: failure to sign informed consent; inclusion in other research protocols Normal weight patients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated<br>Counselling, personalized dietary strategy aimed at increasing the adherence to Mediterranean diet, personalized physical activity program with a personal trainer, use of digital tools (i.e., games, apps) aimed at improving the adherence to dietary/lifestyle indications. | |
| Control<br>generic dietary indications oriented to weight reduction; generic invitations to increase physical activity, routine monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of treatments on Body Mass Index and waist circumference | waist circumference will be measured and expressed in cm. weight and height will be combined to report BMI in kg/m^2. Measurements will be taken at enrollment and during follow-up. | 24 months | 
| Effects of treatments on visceral fat | Measurement of visceral fat by ultrasonography (expressed in mm) will be performed at baseline and during follow-up | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic indices and in hormones involved in the regulation of glucose metabolism | gluco-lipid profile, adipokines, insulinemia, HOMA index will be measured at baseline and during the follow-up | 24 months | 
| Change in hormones involved in nutrient sensing | GLP-1, GIP, total and acylated ghrelin, PYY will be measured at baseline and during the follow-up | 24 months | 
| Effects of microbiota and metabolome | profiling of gut microbiota and assessment of metabolome will be assessed in enrolled subjects at baseline and during follow-up | 24 months | 
| Effects on intestinal permeability | markers of intestinal permeability (blood / urine dosage of LPS, zonulin) urinary dosage of sugars with selective gastrointestinal absorption, aimed at evaluating intestinal permeability at the gastric, ileal and colic level. Assessments will be performed at baseline and during the follow-up | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic disorders, Overweight and Obesity, Cardiovascular diseases, Mediterranean Diet, Lifestyle, Physical activity