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Early Vascular Ageing Among Cypriots (LifeEVA)

U

University of Cyprus

Status

Active, not recruiting

Conditions

Vascular Stiffness
Obesity

Treatments

Behavioral: Lifestyle Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06601491
EEBK/2024/21

Details and patient eligibility

About

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.

Enrollment

352 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

352 participants in 2 patient groups

Intervention
Experimental group
Treatment:
Behavioral: Lifestyle Intervention
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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