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The Trinity, Ulster and Department of Agriculture Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02664584
Acronym
TUDA
Enrollment
5186
Registered
2016-01-27
Start date
2008-12-31
Completion date
2018-12-31
Last updated
2016-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Cardiovascular Disease, Hypertension, Osteoporosis

Brief summary

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.

Interventions

None listed

Sponsors

University of Dublin, Trinity College
CollaboratorOTHER
University College Cork
CollaboratorOTHER
University College Dublin
CollaboratorOTHER
University of Ulster
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>60 years of age

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Depression (CES-D)10 yearsCenter for Epidemiologic Studies Depression Scale (CES-D)
Blood pressure10 years
Bone health (DXA)10 yearsDual energy x ray absorptiometry (DXA) scan
Cognitive function 1 (MMSE)10 yearsMini-Mental State Examination (MMSE)
Cognitive function 2 (FAB)10 yearsFrontal Assessment Battery (FAB)
Cognitive function 3 (RBANS)10 yearsRepeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Anxiety (HADS)10 yearsHospital Anxiety and Depression Scale (HADS)

Secondary

MeasureTime frameDescription
Single nucleotide polymorphisms10 yearsMeasured in DNA sample
Measures of mobility (TUG)10 yearsTimed Up and Go (TUG)
Measures of muscle strength10 yearsHand grip strength (dynamometer)
Bone turnover markers10 yearsMeasured in blood
Routine biochemical markers10 yearsMeasured in blood
Vitamin biomarkers10 yearsMeasured in blood
Weight10 years

Countries

Ireland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026