Early Vascular Ageing Among Cypriots

NCT06601491 | Active Not Recruiting DMC

• 1 other identifier: EEBK/2024/21
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  Every three months, duration: 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Lifestyle Intervention

Control

NO INTERVENTION

Interventions

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).

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cyprus: lead
• Aristotle University Of Thessaloniki: collaborator
• Harokopio University: collaborator

Study Sites (1)

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

Nicosia, Nicosia, 2109, Cyprus

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Panagiota Veloudi, PhD

  University of Cyprus

  PRINCIPAL INVESTIGATOR

• Eleni M Loizidou, PhD

  Cyprus Institute of Neurology and Genetics

  PRINCIPAL INVESTIGATOR

• Constantinos Deltas, PhD

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: September 19, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)