Clinical trial NCT03305276: Observatory on Impact of Life Styles on Health Outcomes
Official title: Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Outcome
Keywords: diet;
exercise;
hypertension;
vitamin d
Lead sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.

Brief summary: 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.

Detailed description: 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) .

Eligibility criteria: Inclusion Criteria:

- General population

Exclusion Criteria:

* Subjects who do not sign informed consent and do not give authorization will be excluded from the study
* Subjects fed through parenteral feeding

Primary outcomes:
measure: cardiovascular events
timeFrame: 10 year
Secondary outcomes:
measure: cardiovascular risk
timeFrame: 10 years
Other outcomes:
measure: vitamin D profile
timeFrame: 10 years
measure: vitamin B12 profile
timeFrame: 10 years
measure: Folic Acid profile
timeFrame: 10 years
Locations:
city: Salerno
country: Italy
facility: San Giovanni e Ruggi Hospital
Study officials:
References: