- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Dublin8
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Dublin, Dublin8, Irlanda
- St James's Hospital
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Londonderry, Reino Unido, BT47 6SB
- Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
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Londonderry
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Coleraine, Londonderry, Reino Unido, BT52 1SA
- Human Intervention Studies Unit, Ulster University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- >60 years of age
Exclusion Criteria:
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Blood pressure
Periodo de tiempo: 10 years
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10 years
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Bone health (DXA)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 10 years
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Frontal Assessment Battery (FAB)
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10 years
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Cognitive function 3 (RBANS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 10 years
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Center for Epidemiologic Studies Depression Scale (CES-D)
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10 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Weight
Periodo de tiempo: 10 years
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10 years
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Routine biochemical markers
Periodo de tiempo: 10 years
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Measured in blood
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10 years
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Vitamin biomarkers
Periodo de tiempo: 10 years
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Measured in blood
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10 years
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Single nucleotide polymorphisms
Periodo de tiempo: 10 years
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Measured in DNA sample
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10 years
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Measures of mobility (TUG)
Periodo de tiempo: 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
Periodo de tiempo: 10 years
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Hand grip strength (dynamometer)
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10 years
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Bone turnover markers
Periodo de tiempo: 10 years
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Measured in blood
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10 years
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Desordenes mentales
- Enfermedades metabólicas
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos neurocognitivos
- Enfermedades musculoesqueléticas
- Enfermedades neurodegenerativas
- Enfermedades óseas
- Demencia
- Tauopatías
- Enfermedades Óseas Metabólicas
- Enfermedades cardiovasculares
- Enfermedad de Alzheimer
- Osteoporosis
Otros números de identificación del estudio
- 08NIR03/113
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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