- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Dublin8
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Dublin, Dublin8, Irlande
- St James's Hospital
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Londonderry, Royaume-Uni, BT47 6SB
- Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
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Londonderry
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Coleraine, Londonderry, Royaume-Uni, BT52 1SA
- Human Intervention Studies Unit, Ulster University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- >60 years of age
Exclusion Criteria:
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Blood pressure
Délai: 10 years
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10 years
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Bone health (DXA)
Délai: 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)
Délai: 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)
Délai: 10 years
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Frontal Assessment Battery (FAB)
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10 years
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Cognitive function 3 (RBANS)
Délai: 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)
Délai: 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)
Délai: 10 years
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Center for Epidemiologic Studies Depression Scale (CES-D)
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10 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Weight
Délai: 10 years
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10 years
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Routine biochemical markers
Délai: 10 years
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Measured in blood
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10 years
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Vitamin biomarkers
Délai: 10 years
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Measured in blood
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10 years
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Single nucleotide polymorphisms
Délai: 10 years
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Measured in DNA sample
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10 years
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Measures of mobility (TUG)
Délai: 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
Délai: 10 years
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Hand grip strength (dynamometer)
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10 years
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Bone turnover markers
Délai: 10 years
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Measured in blood
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10 years
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Maladies métaboliques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Troubles neurocognitifs
- Maladies musculo-squelettiques
- Maladies neurodégénératives
- Maladies osseuses
- Démence
- Tauopathies
- Maladies osseuses métaboliques
- Maladies cardiovasculaires
- Maladie d'Alzheimer
- Ostéoporose
Autres numéros d'identification d'étude
- 08NIR03/113
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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