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Active, not recruitingNCT06601491LifeEVAUpdated Sep 19, 2024

Early Vascular Ageing Among Cypriots

An interventional study of Lifestyle Intervention in Vascular Stiffness and Obesity, sponsored by University of Cyprus. Active, not recruiting at 1 site in Cyprus. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University of Cyprus · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
352
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vascular Stiffness
  • Obesity
03

In context

Lead sponsor

University of Cyprus is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
352 participants (estimated)

Study arms

  • Experimental
    Intervention

    Behavioral: Lifestyle Intervention

  • No intervention
    Control

Interventions

  • BehavioralLifestyle 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Every three months, duration: 1 year

07

Study locations

1 site
  • biobank.cy Center of Excellence in Biobanking and Biomedical Research, University of Cyprus
    Nicosia, 2109, Cyprus
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06601491
Lead sponsor
University of Cyprus
Collaborators
Aristotle University Of Thessaloniki, Harokopio University
Responsible party
Panagiota Veloudi (Researcher, University of Cyprus) — Principal investigator
First posted
Sep 19, 2024
Start date
Aug 8, 2024
Primary completion
Jan 2029 (estimated)
Completion
Jan 2029 (estimated)
Last update
Sep 19, 2024

Study contacts

Panagiota Veloudi, PhD
principal investigator · University of Cyprus
Eleni M Loizidou, PhD
principal investigator · Cyprus Institute of Neurology and Genetics
Constantinos Deltas, PhD
principal investigator · University of Cyprus

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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