- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Dublin8
-
Dublin, Dublin8, Irlanda
- St James's Hospital
-
-
-
-
-
Londonderry, Reino Unido, BT47 6SB
- Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
-
-
Londonderry
-
Coleraine, Londonderry, Reino Unido, BT52 1SA
- Human Intervention Studies Unit, Ulster University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- >60 years of age
Exclusion Criteria:
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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))
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Blood pressure
Prazo: 10 years
|
10 years
|
|
|
Bone health (DXA)
Prazo: 10 years
|
Dual energy x ray absorptiometry (DXA) scan
|
10 years
|
|
Cognitive function 1 (MMSE)
Prazo: 10 years
|
Mini-Mental State Examination (MMSE)
|
10 years
|
|
Cognitive function 2 (FAB)
Prazo: 10 years
|
Frontal Assessment Battery (FAB)
|
10 years
|
|
Cognitive function 3 (RBANS)
Prazo: 10 years
|
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
|
10 years
|
|
Anxiety (HADS)
Prazo: 10 years
|
Hospital Anxiety and Depression Scale (HADS)
|
10 years
|
|
Depression (CES-D)
Prazo: 10 years
|
Center for Epidemiologic Studies Depression Scale (CES-D)
|
10 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Weight
Prazo: 10 years
|
10 years
|
|
|
Routine biochemical markers
Prazo: 10 years
|
Measured in blood
|
10 years
|
|
Vitamin biomarkers
Prazo: 10 years
|
Measured in blood
|
10 years
|
|
Single nucleotide polymorphisms
Prazo: 10 years
|
Measured in DNA sample
|
10 years
|
|
Measures of mobility (TUG)
Prazo: 10 years
|
Timed Up and Go (TUG)
|
10 years
|
|
Measures of muscle strength
Prazo: 10 years
|
Hand grip strength (dynamometer)
|
10 years
|
|
Bone turnover markers
Prazo: 10 years
|
Measured in blood
|
10 years
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Doenças Metabólicas
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Distúrbios Neurocognitivos
- Doenças musculoesqueléticas
- Doenças Neurodegenerativas
- Doenças ósseas
- Demência
- Tauopatias
- Doenças Ósseas Metabólicas
- Doenças cardiovasculares
- Doença de Alzheimer
- Osteoporose
Outros números de identificação do estudo
- 08NIR03/113
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .