Clinical trial NCT06601491: Early Vascular Ageing Among Cypriots
Official title: Lifestyle Randomised Intervention for Healthy Vascular Ageing - a Multifactorial Assessment of Vascular Ageing Among Cypriots in Early Adulthood Through Biobank.cy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vascular Stiffness
Obesity
Lead sponsor: University of Cyprus
Sponsor class: OTHER
Collaborators: name: Aristotle University Of Thessaloniki
name: Harokopio University
First posted: 2024-09-19
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in the Vascular Stiffness as Measured Through Pulse Wave Velocity at 12 Months
timeFrame: Every three months, duration: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: biobank.cy Center of Excellence in Biobanking and Biomedical Research, University of Cyprus
Study officials:
affiliation: University of Cyprus
name: Panagiota Veloudi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cyprus Institute of Neurology and Genetics
name: Eleni M Loizidou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cyprus
name: Constantinos Deltas, PhD
role: PRINCIPAL_INVESTIGATOR
References: