- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Dublin8
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Dublin, Dublin8, Irland
- St James's Hospital
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Londonderry, Storbritannia, BT47 6SB
- Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
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Londonderry
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Coleraine, Londonderry, Storbritannia, BT52 1SA
- Human Intervention Studies Unit, Ulster University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- >60 years of age
Exclusion Criteria:
- <60 years of age
- Born outside the island of Ireland
- Severe dementia
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Blood pressure
Tidsramme: 10 years
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10 years
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Bone health (DXA)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 10 years
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Frontal Assessment Battery (FAB)
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10 years
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Cognitive function 3 (RBANS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 10 years
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Center for Epidemiologic Studies Depression Scale (CES-D)
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10 years
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Weight
Tidsramme: 10 years
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10 years
|
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Routine biochemical markers
Tidsramme: 10 years
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Measured in blood
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10 years
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Vitamin biomarkers
Tidsramme: 10 years
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Measured in blood
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10 years
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Single nucleotide polymorphisms
Tidsramme: 10 years
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Measured in DNA sample
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10 years
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Measures of mobility (TUG)
Tidsramme: 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
Tidsramme: 10 years
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Hand grip strength (dynamometer)
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10 years
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Bone turnover markers
Tidsramme: 10 years
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Measured in blood
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10 years
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Metabolske sykdommer
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Nevrokognitive lidelser
- Muskel- og skjelettsykdommer
- Nevrodegenerative sykdommer
- Beinsykdommer
- Demens
- Tauopatier
- Bensykdommer, metabolske
- Kardiovaskulære sykdommer
- Alzheimers sykdom
- Osteoporose
Andre studie-ID-numre
- 08NIR03/113
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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