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

January 26, 2016 updated by: 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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

5186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 60 and above

Description

Inclusion Criteria:

  • >60 years of age

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 10 years
10 years
Bone health (DXA)
Time Frame: 10 years
Dual energy x ray absorptiometry (DXA) scan
10 years
Cognitive function 1 (MMSE)
Time Frame: 10 years
Mini-Mental State Examination (MMSE)
10 years
Cognitive function 2 (FAB)
Time Frame: 10 years
Frontal Assessment Battery (FAB)
10 years
Cognitive function 3 (RBANS)
Time Frame: 10 years
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
10 years
Anxiety (HADS)
Time Frame: 10 years
Hospital Anxiety and Depression Scale (HADS)
10 years
Depression (CES-D)
Time Frame: 10 years
Center for Epidemiologic Studies Depression Scale (CES-D)
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 10 years
10 years
Routine biochemical markers
Time Frame: 10 years
Measured in blood
10 years
Vitamin biomarkers
Time Frame: 10 years
Measured in blood
10 years
Single nucleotide polymorphisms
Time Frame: 10 years
Measured in DNA sample
10 years
Measures of mobility (TUG)
Time Frame: 10 years
Timed Up and Go (TUG)
10 years
Measures of muscle strength
Time Frame: 10 years
Hand grip strength (dynamometer)
10 years
Bone turnover markers
Time Frame: 10 years
Measured in blood
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulster

Collaborators

University College Dublin
University College Cork
University of Dublin, Trinity College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 14, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08NIR03/113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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