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The Trinity, Ulster and Department of Agriculture Cohort Study (TUDA)

2016年1月26日 更新者:University of Ulster

Background:

Cardiovascular disease (CVD), osteoporosis and dementia are chronic diseases of ageing that impact adversely on the lives of those affected and have major health, social and economic consequences. A number of factors are considered to be implicated in these diseases, ranging from the more established factors to those that are less well recognised. Lifestyle factors such as diet, body weight, smoking, physical activity and years of education are acknowledged as risk factors for the development of these chronic diseases of aging. Emerging research suggests that elevated homocysteine and/or sub-optimal status of the metabolically related B-vitamins (folate, vitamin B12, B6 and riboflavin) may be associated with a higher risk of age-related disease. The interplay between relevant genetic and nutrient factors (gene-nutrient interactions) is considered to be highly relevant in the development (and prevention) of chronic diseases of ageing, however this relatively new area of research is as yet poorly understood. The collection of clinical, lifestyle, nutritional and genetic data on large numbers of patients would permit the investigation of those nutrients which interact with specific genes to increase the likelihood of a person developing chronic diseases of ageing.

Aim:

The aim of the TUDA study is to collect detailed clinical, lifestyle, dietary, genetic and biochemical data to investigate gene-nutrient interactions (particularly from the perspective of the B-vitamins and vitamin D/calcium) in the development of CVD, osteoporosis and dementia by studying older adults exhibiting the early stages of these common diseases, namely hypertension, low bone mineral density, and early memory loss, respectively.

Secondary aim (follow up TUDA investigation):

The aim of this longitudinal investigation is to re-assess clinical, nutritional, genetic and biochemical factors in relation to the progression of disease outcomes in TUDA study participants, in subsequent years after initial investigation.

Study design:

A total of 6000 non-institutionalised older Irish people aged over 60 years with early predictors of either dementia, stroke and osteoporosis (namely early memory loss, high blood pressure and low bone mineral density, respectively) recruited from three centres (St James's Hospital Dublin, Ulster University Coleraine and The Clinical Translational Research and Innovation Centre (C-TRIC), Londonderry) across Ireland. Non-fasting blood samples were collected from all subjects and routine blood biochemistry profiles and biomarkers of relevance to B vitamin and vitamin D status were measured. Supplement use was recorded and a targeted food frequency questionnaire was used to record dietary intakes of specific vitamins of interest (folate, B12, B6, riboflavin and D) from major food sources, particularly fortified foods. Physiological function tests including blood pressure, bone health (DXA scans) and cognitive function tests and anthropometric measures were also taken.

研究概览

研究类型

观察性的

注册 (实际的)

5186

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Dublin8
      • Dublin、Dublin8、爱尔兰
        • St James's Hospital
      • Londonderry、英国、BT47 6SB
        • Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
    • Londonderry
      • Coleraine、Londonderry、英国、BT52 1SA
        • Human Intervention Studies Unit, Ulster University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients aged 60 and above

描述

Inclusion Criteria:

  • >60 years of age

Exclusion Criteria:

  • <60 years of age
  • Born outside the island of Ireland
  • Severe dementia

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Cross-sectional cohort
Cohort who took part in the cross-sectional study (n=5186)
Cross-sectional cohort + follow-up
Cohort who took part in both the cross-sectional and follow-up study (planned n=500 (on-going))

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Blood pressure
大体时间:10 years
10 years
Bone health (DXA)
大体时间:10 years
Dual energy x ray absorptiometry (DXA) scan
10 years
Cognitive function 1 (MMSE)
大体时间:10 years
Mini-Mental State Examination (MMSE)
10 years
Cognitive function 2 (FAB)
大体时间:10 years
Frontal Assessment Battery (FAB)
10 years
Cognitive function 3 (RBANS)
大体时间:10 years
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
10 years
Anxiety (HADS)
大体时间:10 years
Hospital Anxiety and Depression Scale (HADS)
10 years
Depression (CES-D)
大体时间:10 years
Center for Epidemiologic Studies Depression Scale (CES-D)
10 years

次要结果测量

结果测量
措施说明
大体时间
Weight
大体时间:10 years
10 years
Routine biochemical markers
大体时间:10 years
Measured in blood
10 years
Vitamin biomarkers
大体时间:10 years
Measured in blood
10 years
Single nucleotide polymorphisms
大体时间:10 years
Measured in DNA sample
10 years
Measures of mobility (TUG)
大体时间:10 years
Timed Up and Go (TUG)
10 years
Measures of muscle strength
大体时间:10 years
Hand grip strength (dynamometer)
10 years
Bone turnover markers
大体时间:10 years
Measured in blood
10 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年12月1日

初级完成 (预期的)

2018年12月1日

研究完成 (预期的)

2018年12月1日

研究注册日期

首次提交

2016年1月14日

首先提交符合 QC 标准的

2016年1月26日

首次发布 (估计)

2016年1月27日

研究记录更新

最后更新发布 (估计)

2016年1月27日

上次提交的符合 QC 标准的更新

2016年1月26日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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