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临床试验/NCT02664584
NCT02664584Unknown不适用

The Trinity, Ulster and Department of Agriculture Cohort Study

University of Ulster3 个研究点 分布在 2 个国家目标入组 5,186 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
5,186
试验地点
3
主要终点
Cognitive function 3 (RBANS)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >60 years of age

排除标准

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

结局指标

主要结局

Cognitive function 3 (RBANS)

时间窗: 10 years

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Cognitive function 1 (MMSE)

时间窗: 10 years

Mini-Mental State Examination (MMSE)

Bone health (DXA)

时间窗: 10 years

Dual energy x ray absorptiometry (DXA) scan

Blood pressure

时间窗: 10 years

Cognitive function 2 (FAB)

时间窗: 10 years

Frontal Assessment Battery (FAB)

Anxiety (HADS)

时间窗: 10 years

Hospital Anxiety and Depression Scale (HADS)

Depression (CES-D)

时间窗: 10 years

Center for Epidemiologic Studies Depression Scale (CES-D)

次要结局

  • Routine biochemical markers(10 years)
  • Vitamin biomarkers(10 years)
  • Single nucleotide polymorphisms(10 years)
  • Measures of muscle strength(10 years)
  • Weight(10 years)
  • Measures of mobility (TUG)(10 years)
  • Bone turnover markers(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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