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Observatory on Impact of Life Styles on Health Outcomes

Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03305276
Acronym
OIVITA
Enrollment
1500
Registered
2017-10-09
Start date
2014-05-16
Completion date
2024-05-16
Last updated
2017-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Outcome

Keywords

diet;, exercise;, hypertension;, vitamin d

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) .

Interventions

None listed

Sponsors

Guido Iaccarino
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
cardiovascular events10 yearPresence of events in the anamnesis of subjects enrolled

Secondary

MeasureTime frameDescription
cardiovascular risk10 yearsFramingham Risk Score

Other

MeasureTime frameDescription
vitamin D profile10 yearsvitamin d serum levels will be assessed and compared to the life style
vitamin B12 profile10 yearsvitamin b12 serum levels will be assessed and compared to the life style
Folic Acid profile10 yearsfolic acid serum levels will be assessed and compared to the life style

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026