- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Dublin8
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Dublin, Dublin8, Irlanda
- St James's Hospital
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Londonderry, Regno Unito, BT47 6SB
- Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
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Londonderry
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Coleraine, Londonderry, Regno Unito, BT52 1SA
- Human Intervention Studies Unit, Ulster University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- >60 years of age
Exclusion Criteria:
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Blood pressure
Lasso di tempo: 10 years
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10 years
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Bone health (DXA)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 10 years
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Frontal Assessment Battery (FAB)
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10 years
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Cognitive function 3 (RBANS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 10 years
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Center for Epidemiologic Studies Depression Scale (CES-D)
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10 years
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Weight
Lasso di tempo: 10 years
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10 years
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Routine biochemical markers
Lasso di tempo: 10 years
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Measured in blood
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10 years
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Vitamin biomarkers
Lasso di tempo: 10 years
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Measured in blood
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10 years
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Single nucleotide polymorphisms
Lasso di tempo: 10 years
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Measured in DNA sample
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10 years
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Measures of mobility (TUG)
Lasso di tempo: 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
Lasso di tempo: 10 years
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Hand grip strength (dynamometer)
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10 years
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Bone turnover markers
Lasso di tempo: 10 years
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Measured in blood
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10 years
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Malattie metaboliche
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Disturbi neurocognitivi
- Malattie muscoloscheletriche
- Malattie Neurodegenerative
- Malattie ossee
- Demenza
- Tauopatie
- Malattie ossee, metaboliche
- Malattia cardiovascolare
- Malattia di Alzheimer
- Osteoporosi
Altri numeri di identificazione dello studio
- 08NIR03/113
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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