Effects of Personalized Dietary and Lifestyle Treatments on the Reduction of Cardiovascular and Metabolic Risk in Overweight and Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effects of treatments on Body Mass Index and waist circumference
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight or obese patients
- •patients who able to sign informed consent
排除标准
- •failure to sign informed consent;
- •inclusion in other research protocols
- •Normal weight patients
结局指标
主要结局
Effects of treatments on Body Mass Index and waist circumference
时间窗: 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
时间窗: 24 months
Measurement of visceral fat by ultrasonography (expressed in mm) will be performed at baseline and during follow-up
次要结局
- Change in metabolic indices and in hormones involved in the regulation of glucose metabolism(24 months)
- Change in hormones involved in nutrient sensing(24 months)
- Effects of microbiota and metabolome(24 months)
- Effects on intestinal permeability(24 months)
研究者
piero portincasa
Professor, MD
University of Bari