<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243578</url>
  </required_header>
  <id_info>
    <org_study_id>UKBProHealth</org_study_id>
    <nct_id>NCT03243578</nct_id>
  </id_info>
  <brief_title>Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes</brief_title>
  <official_title>Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes in 180,031 UK Biobank Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Glasgow</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Glasgow</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current study was to clarify the relationship between protein intake and&#xD;
      health by using a very large, general population cohort study, UK Biobank, to study the&#xD;
      associations between reported protein intake (expressed in g/day, g/kg/day and % of total&#xD;
      energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2007</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Mean of 7 years</time_frame>
    <description>Date and cause of death were obtained from death certificates</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CVD incidence</measure>
    <time_frame>Mean of 6.1 years</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cancer incidence</measure>
    <time_frame>Mean of 6.1 years</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Actual">502628</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Cancer</condition>
  <condition>All-cause Mortality</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None as this is an observational study</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment from the general population&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Glasgow</investigator_affiliation>
    <investigator_full_name>Stuart Gray</investigator_full_name>
    <investigator_title>Dr Stuart Gray</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Whilst we will not make this data available it is available to all bona fide researchers via the UK Biobank</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243578
org study id: UKBProHealth
nct id: NCT03243578
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
observational model: Cohort
time perspective: Prospective
measure: All-cause mortality
time frame: Mean of 7 years
description: Date and cause of death were obtained from death certificates
measure: CVD incidence
time frame: Mean of 6.1 years
description: 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
measure: cancer incidence
time frame: Mean of 6.1 years
description: 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.
intervention type: Other
intervention name: None as this is an observational study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Glasgow
investigator full name: Stuart Gray
investigator title: Dr Stuart Gray
mesh term: Cardiovascular Diseases
sharing ipd: No
ipd description: Whilst we will not make this data available it is available to all bona fide researchers via the UK Biobank