Cardiovascular Diseases, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease, Overweight and Obesity
Conditions
Keywords
Overweight and Obesity, Cardiovascular diseases, Mediterranean Diet, Lifestyle, Physical activity, Metabolic disorders
Brief summary
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
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
Interventions
None listed
Sponsors
University of Bari
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of treatments on Body Mass Index and waist circumference | 24 months | 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. |
| Effects of treatments on visceral fat | 24 months | Measurement of visceral fat by ultrasonography (expressed in mm) will be performed at baseline and during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of microbiota and metabolome | 24 months | profiling of gut microbiota and assessment of metabolome will be assessed in enrolled subjects at baseline and during follow-up |
| Effects on intestinal permeability | 24 months | 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 |
| Change in hormones involved in nutrient sensing | 24 months | GLP-1, GIP, total and acylated ghrelin, PYY will be measured at baseline and during the follow-up |
| Change in metabolic indices and in hormones involved in the regulation of glucose metabolism | 24 months | gluco-lipid profile, adipokines, insulinemia, HOMA index will be measured at baseline and during the follow-up |
Countries
Italy
Contacts
Primary ContactPiero Portincasa
Outcome results
None listed