Early Vascular Ageing Among Cypriots

Not Applicable

Active, not recruiting

• Conditions: Vascular Stiffness; Obesity
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT06601491
• Lead Sponsor: University of Cyprus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Study First Submitted: 2024-08-08
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-13
• Last Update Submitted: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2029-01
• Study Completion: 2029-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 352

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Lifestyle Intervention	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Vascular Stiffness as Measured Through Pulse Wave Velocity at 12 Months	Every three months, duration: 1 year	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.

Trial Locations

Locations (1)

biobank.cy Center of Excellence in Biobanking and Biomedical Research, University of Cyprus; 🇨🇾 Nicosia, Cyprus