<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/NCT03817944</url>
  </required_header>
  <id_info>
    <org_study_id>CHNS-Cohort-Potato-Mortality</org_study_id>
    <nct_id>NCT03817944</nct_id>
  </id_info>
  <brief_title>Potato Consumption and Risk of Mortality</brief_title>
  <official_title>Potato Consumption and Mortality in Oriental Population: A 22-Year Longitudinal Nationwide Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Although previous studies have linked fried potato consumption with the incidence of&#xD;
      mortality in the US population, the association between potato consumption and mortality in&#xD;
      the Chinese population remains unknown.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study investigated the association of potato, fried potato, unfried potato, and sweet&#xD;
      potato consumption with the incidence of mortality in the China Health and Nutrition Survey&#xD;
      (CHNS).We analyzed the CHNS data and the participants (n = 14,116) over 20 years old were&#xD;
      followed for up to 22 years. The participants were initially free of cancer, myocardial&#xD;
      infarction, apoplexy, and pregnancy. Potato consumption was assessed using validated&#xD;
      semi-quantitative food questionnaires (FFQ) in interviews. In each wave of interviews, the&#xD;
      participants' situations such as alive, dead, or dying was listed and the death months were&#xD;
      recorded. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated using Cox&#xD;
      proportional hazard models with adjustment of potential confounders.In the CHNS cohort, total&#xD;
      potato, fried potato, unfried potato, and sweet potato consumption were all strongly&#xD;
      associated with a reduction in all-cause mortality in both Chinese women and men.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1989</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2011</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>mortality</measure>
    <time_frame>From entry into the study (baseline: 1989-2009) until 2011</time_frame>
    <description>All-cause mortality was the primary outcome of interest in this study. In the CHNS, mortality status was confirmed by reported information in each round of the survey. For each participant, the household register updated the information if they were alive and still present, dying, or dead, and the month of death was recorded. Years of follow-up were calculated from baseline until death or censoring on December 31, 2011, depending on which came first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Potato consumption</measure>
    <time_frame>From entry into the study (baseline: 1989-2009) until 2011</time_frame>
    <description>The frequency and the quantity of daily average consumption of total potatoes, sweet potatoes, fried potatoes, and unfried potatoes (g/day) based on 3-day 24-hr recall</description>
  </secondary_outcome>
  <enrollment type="Actual">14116</enrollment>
  <condition>Morality</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Of the 14,116 participants, 6,493 male and 7,623 female were enrolled, ranging from 20 to&#xD;
        93 years old. People who consumed the potatoes, sweet potatoes, stir-fried potatoes, and&#xD;
        non stir-fried potatoes accounted for 57.52%, 14.6%,51.53%, and 54.82%, respectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 20-93 with complete data on diet and follow-up time&#xD;
&#xD;
          -  Adults with no chronic disease history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 20 years old&#xD;
&#xD;
          -  been reported to be pregnant , to have with myocardial infraction , apoplexy, and&#xD;
             cancers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>93 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jingjing Jiao, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Zhejiang University</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 23, 2019</last_update_submitted>
  <last_update_submitted_qc>January 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Yu Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>potato consumption</keyword>
  <keyword>CHNS</keyword>
  <keyword>mortality</keyword>
  <keyword>fried potato</keyword>
  <keyword>sweet potato</keyword>
  <!-- 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/NCT03817944
org study id: CHNS-Cohort-Potato-Mortality
nct id: NCT03817944
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Although previous studies have linked fried potato consumption with the incidence of
      mortality in the US population, the association between potato consumption and mortality in
      the Chinese population remains unknown.
This study investigated the association of potato, fried potato, unfried potato, and sweet
      potato consumption with the incidence of mortality in the China Health and Nutrition Survey
      (CHNS).We analyzed the CHNS data and the participants (n = 14,116) over 20 years old were
      followed for up to 22 years. The participants were initially free of cancer, myocardial
      infarction, apoplexy, and pregnancy. Potato consumption was assessed using validated
      semi-quantitative food questionnaires (FFQ) in interviews. In each wave of interviews, the
      participants' situations such as alive, dead, or dying was listed and the death months were
      recorded. Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated using Cox
      proportional hazard models with adjustment of potential confounders.In the CHNS cohort, total
      potato, fried potato, unfried potato, and sweet potato consumption were all strongly
      associated with a reduction in all-cause mortality in both Chinese women and men.
observational model: Cohort
time perspective: Prospective
measure: mortality
time frame: From entry into the study (baseline: 1989-2009) until 2011
description: All-cause mortality was the primary outcome of interest in this study. In the CHNS, mortality status was confirmed by reported information in each round of the survey. For each participant, the household register updated the information if they were alive and still present, dying, or dead, and the month of death was recorded. Years of follow-up were calculated from baseline until death or censoring on December 31, 2011, depending on which came first.
measure: Potato consumption
time frame: From entry into the study (baseline: 1989-2009) until 2011
description: The frequency and the quantity of daily average consumption of total potatoes, sweet potatoes, fried potatoes, and unfried potatoes (g/day) based on 3-day 24-hr recall
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 93 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jingjing Jiao, PhD
role: Study Director
affiliation: Zhejiang University
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Yu Zhang
investigator title: Professor