The Trinity, Ulster and Department of Agriculture Cohort Study (TUDA)
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|ClinicalTrials.gov Identifier: NCT02664584|
Recruitment Status : Unknown
Verified January 2016 by University of Ulster.
Recruitment status was: Active, not recruiting
First Posted : January 27, 2016
Last Update Posted : January 27, 2016
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.
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.
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.
|Condition or disease|
|Cardiovascular Disease Osteoporosis Alzheimer's Disease Hypertension|
|Study Type :||Observational|
|Actual Enrollment :||5186 participants|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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))
- Blood pressure [ Time Frame: 10 years ]
- Bone health (DXA) [ Time Frame: 10 years ]Dual energy x ray absorptiometry (DXA) scan
- Cognitive function 1 (MMSE) [ Time Frame: 10 years ]Mini-Mental State Examination (MMSE)
- Cognitive function 2 (FAB) [ Time Frame: 10 years ]Frontal Assessment Battery (FAB)
- Cognitive function 3 (RBANS) [ Time Frame: 10 years ]Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
- Anxiety (HADS) [ Time Frame: 10 years ]Hospital Anxiety and Depression Scale (HADS)
- Depression (CES-D) [ Time Frame: 10 years ]Center for Epidemiologic Studies Depression Scale (CES-D)
- Weight [ Time Frame: 10 years ]
- Routine biochemical markers [ Time Frame: 10 years ]Measured in blood
- Vitamin biomarkers [ Time Frame: 10 years ]Measured in blood
- Single nucleotide polymorphisms [ Time Frame: 10 years ]Measured in DNA sample
- Measures of mobility (TUG) [ Time Frame: 10 years ]Timed Up and Go (TUG)
- Measures of muscle strength [ Time Frame: 10 years ]Hand grip strength (dynamometer)
- Bone turnover markers [ Time Frame: 10 years ]Measured in blood
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664584
|St James's Hospital|
|Dublin, Dublin8, Ireland|
|Human Intervention Studies Unit, Ulster University|
|Coleraine, Londonderry, United Kingdom, BT52 1SA|
|Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital|
|Londonderry, United Kingdom, BT47 6SB|