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The Trinity, Ulster and Department of Agriculture Cohort Study (TUDA)

26. januar 2016 opdateret af: University of Ulster

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

5186

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Londonderry, Det Forenede Kongerige, BT47 6SB
        • Clinical Translational Research and Innovation Centre (C-TRIC), Altnagelvin Hospital
    • Londonderry
      • Coleraine, Londonderry, Det Forenede Kongerige, BT52 1SA
        • Human Intervention Studies Unit, Ulster University
    • Dublin8
      • Dublin, Dublin8, Irland
        • St James's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients aged 60 and above

Beskrivelse

Inclusion Criteria:

  • >60 years of age

Exclusion Criteria:

  • <60 years of age
  • Born outside the island of Ireland
  • Severe dementia

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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))

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure
Tidsramme: 10 years
10 years
Bone health (DXA)
Tidsramme: 10 years
Dual energy x ray absorptiometry (DXA) scan
10 years
Cognitive function 1 (MMSE)
Tidsramme: 10 years
Mini-Mental State Examination (MMSE)
10 years
Cognitive function 2 (FAB)
Tidsramme: 10 years
Frontal Assessment Battery (FAB)
10 years
Cognitive function 3 (RBANS)
Tidsramme: 10 years
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
10 years
Anxiety (HADS)
Tidsramme: 10 years
Hospital Anxiety and Depression Scale (HADS)
10 years
Depression (CES-D)
Tidsramme: 10 years
Center for Epidemiologic Studies Depression Scale (CES-D)
10 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Weight
Tidsramme: 10 years
10 years
Routine biochemical markers
Tidsramme: 10 years
Measured in blood
10 years
Vitamin biomarkers
Tidsramme: 10 years
Measured in blood
10 years
Single nucleotide polymorphisms
Tidsramme: 10 years
Measured in DNA sample
10 years
Measures of mobility (TUG)
Tidsramme: 10 years
Timed Up and Go (TUG)
10 years
Measures of muscle strength
Tidsramme: 10 years
Hand grip strength (dynamometer)
10 years
Bone turnover markers
Tidsramme: 10 years
Measured in blood
10 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2008

Primær færdiggørelse (Forventet)

1. december 2018

Studieafslutning (Forventet)

1. december 2018

Datoer for studieregistrering

Først indsendt

14. januar 2016

Først indsendt, der opfyldte QC-kriterier

26. januar 2016

Først opslået (Skøn)

27. januar 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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