Outcome Clinical Trial
Official title:
Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health
The present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). The study was approved by the relevant institutional Ethical Committee of Salerno University.
In occasion of the World Hypertension Day in may , boots are organized in the major squares
of the southern italy villages, and volunteers of the Medical School of Salerno collect
through means of questionnaires, anamnestic data and dietary habits, and measure blood
pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using
validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the
ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events
(coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug
treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn
from the antecubital vein and blood is stored for biochemical analysis at the University
Hospital Centralized Service. Data are digitally stored for analysis.
Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol,
systolic BP and cigarette smoking pre-existing conditions and way of life are used for the
calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score.
Familiarity for cardiovascular disease is defined as cardiovascular events in parents and
siblings less than 50 years old.
The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to
assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous
blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the
last meal was recorded during the data collection. Blood glucose, insulin, blood urea
nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL
cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed.
Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) .
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