Early Vascular Ageing Among Cypriots (LifeEVA)

Lifestyle Randomised Intervention for Healthy Vascular Ageing - a Multifactorial Assessment of Vascular Ageing Among Cypriots in Early Adulthood Through Biobank.cy

The LifeEVA project aims to tackle the significant public health challenge of cardiovascular disease (CVD) by addressing early vascular ageing (EVA), characterized by increased arterial stiffness and reduced vascular compliance, particularly in young adults. The project seeks to develop and implement innovative, personalized lifestyle interventions targeting Cypriots aged 18-40 who are overweight or obese. Utilizing genetic data from biobank.cy, LifeEVA aims to understand the progression of EVA and reduce CVD risk through tailored dietary and physical activity counseling.

The methodology involves a prospective, randomized, open-label, blinded endpoint trial over one year. Participants will be recruited from biobank.cy's database, ensuring a robust sample. They will receive personalized interventions based on their genetic profile, including a hypocaloric diet, physical activity plan and taking into account other factors (i.e. sleep, anxiety etc). The project's work is divided into five work packages: project management, dissemination and exploitation activities, baseline assessment and recruitment, intervention implementation and data collection, and data analysis and manuscript preparation.

Anticipated results include significant reductions in vascular stiffness, improved cardiovascular health markers, and enhanced understanding of the interplay between genetics and lifestyle in EVA. The project's impact extends to the establishment of a vascular health assessment clinic, contributions to public health by reducing CVD prevalence, and advancing the field of personalized preventive healthcare. LifeEVA is positioned to make significant contributions to cardiovascular research, promote innovation, and enhance the scientific and public health landscape in Cyprus.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity; Vascular Stiffness
• Intervention / Treatment: Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Estimated): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Nicosia, Cyprus, 2109
    • biobank.cy Center of Excellence in Biobanking and Biomedical Research, University of Cyprus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 - 40 years old.
• BMI≥25 kg/m².
• WC≥0.9 m for men and ≥0.8 m for women

Exclusion Criteria:

• Individuals with a history of eating disorders.
• Those with significant chronic diseases like advanced cardiovascular diseases
• Pregnant or breastfeeding women or women to intend/are in the process of trying to get pregnant within 1-year after intervention onset.
• Individuals currently on medication or diets that significantly affect metabolism or body weight.
• Those who have participated in another weight loss program or study within the last six months.
• Taking any vasoactive medications.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Lifestyle Intervention; Participants in the intervention group receive structured, pesonalised lifestyle, dietary and physical activity consultations. They undergo various assessments such as aortic stiffness measurement, blood pressure measurement, and complete several questionnaires (e.g., whole exome sequencing, IPAQ, handgrip strength, socio-demographic, clinical history, quality of life, smoking, alcohol consumption, sleep patterns, stress assessment).
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Vascular Stiffness as Measured Through Pulse Wave Velocity at 12 Months	Vascular stiffness will be assessed by measuring pulse wave velocity. Pulse wave velocity is the speed at which the arterial pulse travels through the circulatory system, a key indicator of arterial stiffness.	Every three months, duration: 1 year

Collaborators and Investigators

• Sponsor: University of Cyprus
• Collaborators: Aristotle University Of Thessaloniki; Harokopio University
• Investigators: Principal Investigator: Panagiota Veloudi, PhD, University of Cyprus; Principal Investigator: Eleni M Loizidou, PhD, Cyprus Institute of Neurology and Genetics; Principal Investigator: Constantinos Deltas, PhD, University of Cyprus

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EEBK/2024/21

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
• product manufactured in and exported from the U.S.: No