Cardiovascular DiseaseTUDANCT02664584
The Trinity, Ulster and Department of Agriculture Cohort Study
An observational study of Cardiovascular Disease and Osteoporosis, run by University of Ulster at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Disease, Osteoporosis, Alzheimer's Disease
- How many people
- 5,186 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Dec 2008to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 60 and above
Who may be able to join
- >60 years of age
Who cannot join
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Human Intervention Studies Unit, Ulster University
Coleraine, Londonderry, BT52 1SA
Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
Londonderry, Londonderry, BT47 6SB
About this study
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.
Read more
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.
- Medical subject headings
- Cardiovascular Diseases, Osteoporosis, Alzheimer Disease, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 10 years
Bone health (DXA)
Dual energy x ray absorptiometry (DXA) scan
Measured: 10 years
Cognitive function 1 (MMSE)
Mini-Mental State Examination (MMSE)
Measured: 10 years
Cognitive function 2 (FAB)
Frontal Assessment Battery (FAB)
Measured: 10 years
Cognitive function 3 (RBANS)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: 10 years
Anxiety (HADS)
Hospital Anxiety and Depression Scale (HADS)
Measured: 10 years
Depression (CES-D)
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: 10 years
Secondary outcomes (7)
Weight
Measured: 10 years
Routine biochemical markers
Measured in blood
Measured: 10 years
Vitamin biomarkers
Measured in blood
Measured: 10 years
Single nucleotide polymorphisms
Measured in DNA sample
Measured: 10 years
Measures of mobility (TUG)
Timed Up and Go (TUG)
Measured: 10 years
Measures of muscle strength
Hand grip strength (dynamometer)
Measured: 10 years
Bone turnover markers
Measured in blood
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startDec 2008
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College, University College Cork, University College Dublin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664584
- Sponsor's protocol ID
- 08NIR03/113
- Acronym
- TUDA
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gordon S, Hoey L, McNulty H, Keenan J, Pangilinan F, Brody LC, Ward M, Strain JJ, McAnena L, McCann A, Molloy AM, Cunningham C, McCarroll K, Hughes CF. Associations of one-carbon metabolism, related B-vitamins and ApoE genotype with cognitive function in older adults: identification of a novel gene-nutrient interaction. BMC Med. 2025 Jul 28;23(1):440. doi: 10.1186/s12916-025-04276-8.
PubMed 40717068Fitzpatrick D, Laird E, Ward M, Hoey L, Hughes CF, Strain JJ, Cunningham C, Healy M, Molloy AM, McNulty H, Lannon R, McCarroll K. Secondary hyperparathyroidism: Predictors and relationship with vitamin D status, bone turnover markers and bone mineral density. Bone. 2024 Jul;184:117108. doi: 10.1016/j.bone.2024.117108. Epub 2024 Apr 18.
PubMed 38642819Jarrett H, McNulty H, Hughes CF, Pentieva K, Strain JJ, McCann A, McAnena L, Cunningham C, Molloy AM, Flynn A, Hopkins SM, Horigan G, O'Connor C, Walton J, McNulty BA, Gibney MJ, Lamers Y, Ward M. Vitamin B-6 and riboflavin, their metabolic interaction, and relationship with MTHFR genotype in adults aged 18-102 years. Am J Clin Nutr. 2022 Dec 19;116(6):1767-1778. doi: 10.1093/ajcn/nqac240.
PubMed 36264281
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Trinity, Ulster and Department of Agriculture Cohort Study
- ClinicalTrials.gov ID
- NCT02664584
- Acronym / sponsor ID
- TUDA / 08NIR03/113
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,186 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College, University College Cork, University College Dublin
- Study start
- Dec 2008
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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)) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 60 and above
Key inclusion criteria (1 listed)
- >60 years of age
Key exclusion criteria (3 listed)
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
7 secondary outcomes
Weight
Time frame: 10 years
Routine biochemical markers
Time frame: 10 years
Vitamin biomarkers
Time frame: 10 years
Single nucleotide polymorphisms
Time frame: 10 years
Measures of mobility (TUG)
Time frame: 10 years
Measures of muscle strength
Time frame: 10 years
Bone turnover markers
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 40717068Gordon S, Hoey L, McNulty H, Keenan J, Pangilinan F, Brody LC, Ward M, Strain JJ, McAnena L, McCann A, Molloy AM, Cunningham C, McCarroll K, Hughes CF. Associations of one-carbon metabolism, related B-vitamins and ApoE genotype with cognitive function in older adults: identification of a novel gene-nutrient interaction. BMC Med. 2025 Jul 28;23(1):440. doi: 10.1186/s12916-025-04276-8.
- Derived from this study: PubMed 38642819Fitzpatrick D, Laird E, Ward M, Hoey L, Hughes CF, Strain JJ, Cunningham C, Healy M, Molloy AM, McNulty H, Lannon R, McCarroll K. Secondary hyperparathyroidism: Predictors and relationship with vitamin D status, bone turnover markers and bone mineral density. Bone. 2024 Jul;184:117108. doi: 10.1016/j.bone.2024.117108. Epub 2024 Apr 18.
- Derived from this study: PubMed 36264281Jarrett H, McNulty H, Hughes CF, Pentieva K, Strain JJ, McCann A, McAnena L, Cunningham C, Molloy AM, Flynn A, Hopkins SM, Horigan G, O'Connor C, Walton J, McNulty BA, Gibney MJ, Lamers Y, Ward M. Vitamin B-6 and riboflavin, their metabolic interaction, and relationship with MTHFR genotype in adults aged 18-102 years. Am J Clin Nutr. 2022 Dec 19;116(6):1767-1778. doi: 10.1093/ajcn/nqac240.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Osteoporosis, run by University of Ulster at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 10 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02664584, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.