- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT02664584
The Trinity, Ulster and Department of Agriculture Cohort Study (TUDA)
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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Dublin8
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Dublin, Dublin8, Ierland
- St James's Hospital
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Londonderry, Verenigd Koninkrijk, BT47 6SB
- Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
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Londonderry
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Coleraine, Londonderry, Verenigd Koninkrijk, BT52 1SA
- Human Intervention Studies Unit, Ulster University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- >60 years of age
Exclusion Criteria:
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Cross-sectional cohort
Cohort who took part in the cross-sectional study (n=5186)
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Cross-sectional cohort + follow-up
Cohort who took part in both the cross-sectional and follow-up study (planned n=500 (on-going))
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Blood pressure
Tijdsspanne: 10 years
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10 years
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Bone health (DXA)
Tijdsspanne: 10 years
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Dual energy x ray absorptiometry (DXA) scan
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10 years
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Cognitive function 1 (MMSE)
Tijdsspanne: 10 years
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Mini-Mental State Examination (MMSE)
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10 years
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Cognitive function 2 (FAB)
Tijdsspanne: 10 years
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Frontal Assessment Battery (FAB)
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10 years
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Cognitive function 3 (RBANS)
Tijdsspanne: 10 years
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Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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10 years
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Anxiety (HADS)
Tijdsspanne: 10 years
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Hospital Anxiety and Depression Scale (HADS)
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10 years
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Depression (CES-D)
Tijdsspanne: 10 years
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Center for Epidemiologic Studies Depression Scale (CES-D)
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10 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Weight
Tijdsspanne: 10 years
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10 years
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Routine biochemical markers
Tijdsspanne: 10 years
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Measured in blood
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10 years
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Vitamin biomarkers
Tijdsspanne: 10 years
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Measured in blood
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10 years
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Single nucleotide polymorphisms
Tijdsspanne: 10 years
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Measured in DNA sample
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10 years
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Measures of mobility (TUG)
Tijdsspanne: 10 years
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Timed Up and Go (TUG)
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10 years
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Measures of muscle strength
Tijdsspanne: 10 years
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Hand grip strength (dynamometer)
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10 years
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Bone turnover markers
Tijdsspanne: 10 years
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Measured in blood
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10 years
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Metabole ziekten
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Neurocognitieve stoornissen
- Musculoskeletale aandoeningen
- Neurodegeneratieve ziekten
- Botziekten
- Dementie
- Tauopathieën
- Botziekten, Metabool
- Hart-en vaatziekten
- Ziekte van Alzheimer
- Osteoporose
Andere studie-ID-nummers
- 08NIR03/113
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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