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Active, Not Recruiting

NCT Number: NCT06601491

Early Vascular Ageing Among Cypriots

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nicosia, 2109, Cyprus

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

Behavioral

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).

Primary outcomes

  1. Change from Baseline in the Vascular Stiffness as Measured Through Pulse Wave Velocity at 12 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Cyprus

Other

Collaborators

  • Aristotle University Of Thessaloniki
  • Harokopio University

Registry information

Official study title

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

Acronym: LifeEVA

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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