跳至主要内容
临床试验/NCT06601491
NCT06601491进行中(未招募)不适用

Lifestyle Randomised Intervention for Healthy Vascular Ageing - a Multifactorial Assessment of Vascular Ageing Among Cypriots in Early Adulthood Through Biobank.cy

University of Cyprus2 个研究点 分布在 1 个国家目标入组 352 人开始时间: 2024年8月8日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
352
试验地点
2
主要终点
Change from Baseline in the Vascular Stiffness as Measured Through Pulse Wave Velocity at 12 Months

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Change from Baseline in the Vascular Stiffness as Measured Through Pulse Wave Velocity at 12 Months

时间窗: Every three months, duration: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Panagiota Veloudi

Researcher

University of Cyprus

研究点 (2)

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