Observatory on Impact of Life Styles on Health Outcomes (OIVITA)

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.

Study Overview

• Status: Recruiting
• Conditions: Outcome

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) .

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

Study Locations

• Italy
  • Salerno, Italy, 84100
    • Recruiting
    • San Giovanni e Ruggi Hospital
    • Contact: Guido Iaccarino, MD; Phone Number: 39089672335; Email: guido.iaccarino@sangiovannieruggi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteers from Southern Italy will be recruited in occasion of health promoting events in villages.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
general population; the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular events	Presence of events in the anamnesis of subjects enrolled	10 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiovascular risk	Framingham Risk Score	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
vitamin D profile	vitamin d serum levels will be assessed and compared to the life style	10 years
vitamin B12 profile	vitamin b12 serum levels will be assessed and compared to the life style	10 years
Folic Acid profile	folic acid serum levels will be assessed and compared to the life style	10 years

Collaborators and Investigators

• Sponsor: Guido Iaccarino

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2014
• Primary Completion (Anticipated): July 16, 2020
• Study Completion (Anticipated): May 16, 2024

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: vitamin d; diet;; exercise;; hypertension
• Other Study ID Numbers: 1234 (Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No