Cardiovascular DiseasesNCT03243578
Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes
An observational study of Cardiovascular Diseases and Cancer, run by University of Glasgow.
Trial summary
The aim of the current study was to clarify the relationship between protein intake and health by using a very large, general population cohort study, UK Biobank, to study the associations between reported protein intake (expressed in g/day, g/kg/day and % of total energy intake) and three health outcomes (all-cause… Read more about this study
- Who is it for?
- Ages 40 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cancer, All-cause Mortality
- What is being tested?
- None as this is an observational study
- How many people
- 502,628 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recruitment from the general population
Who may be able to join
- None
Who cannot join
- None
About this study
Official title: Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes in 180,031 UK Biobank Participants
The aim of the current study was to clarify the relationship between protein intake and health by using a very large, general population cohort study, UK Biobank, to study the associations between reported protein intake (expressed in g/day, g/kg/day and % of total energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).
- Conditions
- Cardiovascular Diseases, Cancer, All-cause Mortality
- Being tested
- None as this is an observational study
- Medical subject headings
- Cardiovascular Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None as this is an observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Date and cause of death were obtained from death certificates
Measured: Mean of 7 years
CVD incidence
Date and cause of hospital admissions were identified via record linkage to Health Episode Statistics (HES) records for England and Wales and to the Scottish Morbidity Records (SMR01) for Scotland
Measured: Mean of 6.1 years
cancer incidence
Data on cancer diagnoses for participants resident in England and Wales is provided to UK Biobank by the Medical Research Information Service, based at the National Health Service Information Centre (http://www.ic.nhs.uk/services/medical-research-informationservice). The Information Services Division (http://www.isdscotland.org/HealthTopics/Cancer/), which is a part of NHS Scotland, provides UK Biobank with the cancer data records for participants resident in Scotland.
Measured: Mean of 6.1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study startApr 2007
- Primary completionDec 2010
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 502,628 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Gray, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243578
- Sponsor's protocol ID
- UKBProHealth
- Status last verified
- Aug 2017
- First submitted
- 1 Aug 2017
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Whilst we will not make this data available it is available to all bona fide researchers via the UK Biobank
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes in 180,031 UK Biobank Participants
- ClinicalTrials.gov ID
- NCT03243578
- Acronym / sponsor ID
- UKBProHealth
- Conditions
- Cardiovascular Diseases, Cancer, All-cause Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502,628 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- Apr 2007 (actual)
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study was to clarify the relationship between protein intake and health by using a very large, general population cohort study, UK Biobank, to study the associations between reported protein intake (expressed in g/day, g/kg/day and % of total energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment from the general population
Key inclusion criteria (1 listed)
- None
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None as this is an observational study | Other | – |
Primary outcome
All-cause mortality
Time frame: Mean of 7 years
Date and cause of death were obtained from death certificates
CVD incidence
Time frame: Mean of 6.1 years
Date and cause of hospital admissions were identified via record linkage to Health Episode Statistics (HES) records for England and Wales and to the Scottish Morbidity Records (SMR01) for Scotland
cancer incidence
Time frame: Mean of 6.1 years
Data on cancer diagnoses for participants resident in England and Wales is provided to UK Biobank by the Medical Research Information Service, based at the National Health Service Information Centre (http://www.ic.nhs.uk/services/medical-research-informationservice). The Information Services Division (http://www.isdscotland.org/HealthTopics/Cancer/), which is a part of NHS Scotland, provides UK Biobank with the cancer data records for participants resident in Scotland.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No. Whilst we will not make this data available it is available to all bona fide researchers via the UK Biobank
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cancer, run by University of Glasgow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Mean of 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.