Early Vascular Ageing Among Cypriots

NCT ID: NCT06601491

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2029-01-31

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.

Conditions

Vascular Stiffness; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Lifestyle Intervention

Intervention Type: 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).

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle 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).

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: collaborator

Harokopio University

OTHER

Sponsor Role: collaborator

University of Cyprus

OTHER

Sponsor Role: lead

Responsible Party

Panagiota Veloudi

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Panagiota Veloudi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cyprus

Eleni M Loizidou, PhD

Role: PRINCIPAL_INVESTIGATOR

Cyprus Institute of Neurology and Genetics

Constantinos Deltas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cyprus

Locations

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

Nicosia, Nicosia, Cyprus

Countries

Cyprus

Other Identifiers

EEBK/2024/21

Identifier Type: -

Identifier Source: org_study_id