Condition category
Cancer
Date applied
06/10/2017
Date assigned
30/11/2017
Last edited
06/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
While there are many ideas about the effects of diet on the risk of developing cancer and other diseases, understanding of the health effects of diet is far from complete. The aim of this study is to examine the effects of diet on the risk of developing cancer and other diseases, including but not limited to cardiovascular (heart) diseases, metabolic disorders, bone health, and gastrointestinal (digestive system) diseases.

Who can participate?
Men and women who live within reasonable travelling distance (about 25 km) of one of the 22 assessment centres

What does the study involve?
Participants attend a clinical visit during which lifestyle and physical measurements are taken. Their health data records are used to assess the links between various dietary factors (e.g. nutrients and food intakes or habitual diet groups) and incidence or mortality (death) from cancer or other diseases, with follow-up until December 2014 in the first instance, and with additional follow-up as this information is collected.

What are the possible benefits and risks of participating?
There are no expected benefits or risks of participation except for the time required for the clinical visit (about 90 minutes).

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
September 2004 to December 2014

Who is funding the study?
1. Medical Research Council (UK)
2. Wellcome Trust (UK)

Who is the main contact?
Dr Kathryn Bradbury

Trial website

http://www.ukbiobank.ac.uk/2013/06/ms-kathryn-bradbury-university-of-oxford-cancer-epidemiology-unit-oxford/

Contact information

Type

Scientific

Primary contact

Dr Kathryn Bradbury

ORCID ID

Contact details

Cancer Epidemiology Unit
Richard Doll Building
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UK Biobank project number 3037

Study information

Scientific title

Diet and risk of cancer and other diseases in the UK Biobank: a longitudinal cohort study

Acronym

Study hypothesis

To develop a research programme on diet in UK Biobank, to study the effects of diet on the risk of cancer and other diseases.

Ethics approval

Permission for access to patient records for recruitment was approved by the Patient Information Advisory Group (subsequently replaced by the National Information Governance Board for Health and Social Care) in England and Wales, and the Community Health Index Advisory Group in Scotland, 17/06/2011, ref: 11/NW/0382

Study design

Longitudinal cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Cancer and other diseases or conditions, including but not limited to cardiovascular diseases, metabolic disorders, bone health, anaemia, gastrointestinal disease, and intermediate markers of health related to the above diseases, such as anthropometry, physical characteristics and biomarkers

Intervention

The trialists will be assessing the association between various dietary factors (e.g. nutrients and food intakes or habitual diet groups) and incidence or mortality from cancer or other diseases, including but not limited to cardiovascular diseases, metabolic disorders, bone health, and gastrointestinal diseases, and characterisation of intermediate markers, either as cross-sectional analyses or longitudinal analyses with follow-up until December 2014 in the first instance, and subsequently with additional follow-up as this information is accrued.

Intervention type

Phase

Drug names

Primary outcome measure

Incidence or mortality from cancer, measured via record linkage to hospital records or death registries longitudinally for indefinite periods at whichever time point the event occurs

Secondary outcome measures

1. Incidence or mortality from other diseases, including but not limited to cardiovascular diseases, metabolic disorders, bone health, and gastrointestinal diseases, measured via record linkage to hospital records or death registries longitudinally for indefinite periods at whichever time point the event occurs
2. Intermediate markers: anthropometric measures (bio-impedance and DEXA scans), bone mineral density (heel bone ultrasound), blood pressure and pulse rate (blood pressure monitor), grip strength (dynamometer), and blood counts (various assays), measured at baseline

Overall trial start date

14/09/2004

Overall trial end date

31/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Men and women who lived within reasonable travelling distance (~25 km) of one of the 22 assessment centres

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

500000

Participant exclusion criteria

No pre-specified exclusion criteria

Recruitment start date

13/03/2006

Recruitment end date

01/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Epidemiology Unit, University of Oxford
OX3 7LF

Sponsor information

Organisation

Cancer Epidemiology Unit, University of Oxford

Sponsor details

Richard Doll Building
University of Oxford
Old Road Campus
Oxford
OX3 7LF
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Wellcome Trust

Alternative name(s)

Wellcome

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Funder name

Girdlers New Zealand Health Research Council

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

For further details of the UK Biobank study protocol and recruitment methods, please visit http://www.ukbiobank.ac.uk/resources/. Other resources will not be publicly available but researchers are welcome to send in enquiries to the corresponding author. Multiple publications planned in peer-reviewed journals from October 2017 onwards.

IPD sharing statement
UK Biobank is an open access resource. Bona fide researchers can obtain further information or apply to use the UK Biobank dataset by registering and applying at http://www.ukbiobank.ac.uk/register-apply/.

Intention to publish date

31/10/2017

Participant level data

Available on request

Basic results (scientific)

Publication list

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29868910

Publication citations

Additional files

Editorial Notes

06/06/2018: Publication reference added.