<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/NCT03281512</url>
  </required_header>
  <id_info>
    <org_study_id>Cohort_SFA</org_study_id>
    <nct_id>NCT03281512</nct_id>
  </id_info>
  <brief_title>Saturated Fatty Acids Intake and Mortality, Diabetes, Hypertension and Overweight</brief_title>
  <official_title>Saturated Fatty Acids Intake and Mortality, Diabetes, Hypertension and Overweight in the China Health and Nutrition Survey (CHNS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Health and Nutrition</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      The role of saturated fatty acids (SFAs) intake in the development of total death,&#xD;
      cardiovascular diseases, diabetes, hypertension and overweight are in great controversy but&#xD;
      evidence from large population in China is scant.The investigators aim to use the data from&#xD;
      the China Health and Nutrition Survey to assess the long-term association of SFAs intake with&#xD;
      total mortality, diabetes, hypertension and overweight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The role of saturated fatty acids (SFAs) intake in the development of total death, diabetes,&#xD;
      hypertension and overweight are in great controversy but evidence from large population in&#xD;
      China is lacking.The investigators aim to utilize the data from the China Health and&#xD;
      Nutrition Survey. The investigators will calculate the cumulative average intake of SFAs&#xD;
      based on 3 consecutive 24-h dietary recalls in each round.Sex-specific Cox regression models&#xD;
      will be used to estimate the relative risk.Results from our work will be used to provide&#xD;
      epidemiological evidence for improving recommendation on SFAs intake for Chinese in dietary&#xD;
      guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1989</start_date>
  <completion_date type="Actual">December 31, 2012</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 baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years</time_frame>
    <description>Incidence of all-cause death, on basis of household members' report</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diabetes</measure>
    <time_frame>From entry into the study (baseline: 1997-2009) until 2011</time_frame>
    <description>Incidence of diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Saturated fatty acids intake</measure>
    <time_frame>From entry into the study (baseline: 1997-2009) until 2011</time_frame>
    <description>Cumulative average intake of saturated fatty acids on basis of 3 consecutive 24-h dietary recalls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypertension</measure>
    <time_frame>From entry into the study (baseline: 1997-2009) until 2011</time_frame>
    <description>Incidence of hypertension, on basis of self-reported physician diagnosis, systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overweight</measure>
    <time_frame>From entry into the study (baseline: 1997-2009) until 2011</time_frame>
    <description>Incidence of overweight, on basis of body mass index (BMI), BMI ≥ 24 kg/㎡</description>
  </secondary_outcome>
  <enrollment type="Actual">14383</enrollment>
  <condition>Morality</condition>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <condition>Overweight</condition>
  <eligibility>
    <study_pop>
      <textblock>
        CHNS is an ongoing, large-scale, household-based cohort starting in 1989. The survey used a&#xD;
        multi-stage, random cluster process to draw a sample of 9 provinces and municipal cities,&#xD;
        which take up about half of Chinese population.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged ≥20 with complete data on diet and follow-up time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiovascular diseases&#xD;
&#xD;
          -  Diabetes (for analyses of diabetes)&#xD;
&#xD;
          -  Body mass index ≥ 24 kg/㎡ (for analyses of overweight)&#xD;
&#xD;
          -  Hypertension (for analyses of hypertension)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang University</investigator_affiliation>
    <investigator_full_name>Jingjing Jiao</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Saturated fatty acids</keyword>
  <keyword>CHNS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- 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/NCT03281512
org study id: Cohort_SFA
nct id: NCT03281512
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The role of saturated fatty acids (SFAs) intake in the development of total death,
      cardiovascular diseases, diabetes, hypertension and overweight are in great controversy but
      evidence from large population in China is scant.The investigators aim to use the data from
      the China Health and Nutrition Survey to assess the long-term association of SFAs intake with
      total mortality, diabetes, hypertension and overweight.
The role of saturated fatty acids (SFAs) intake in the development of total death, diabetes,
      hypertension and overweight are in great controversy but evidence from large population in
      China is lacking.The investigators aim to utilize the data from the China Health and
      Nutrition Survey. The investigators will calculate the cumulative average intake of SFAs
      based on 3 consecutive 24-h dietary recalls in each round.Sex-specific Cox regression models
      will be used to estimate the relative risk.Results from our work will be used to provide
      epidemiological evidence for improving recommendation on SFAs intake for Chinese in dietary
      guidelines.
observational model: Cohort
time perspective: Prospective
measure: Mortality
time frame: From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years
description: Incidence of all-cause death, on basis of household members' report
measure: Diabetes
time frame: From entry into the study (baseline: 1997-2009) until 2011
description: Incidence of diabetes, on basis of self-reported physician diagnosis, fasting plasma glucose ≥ 7.0 mmol/l or HbA1c ≥ 6.5%
measure: Saturated fatty acids intake
time frame: From entry into the study (baseline: 1997-2009) until 2011
description: Cumulative average intake of saturated fatty acids on basis of 3 consecutive 24-h dietary recalls
measure: Hypertension
time frame: From entry into the study (baseline: 1997-2009) until 2011
description: Incidence of hypertension, on basis of self-reported physician diagnosis, systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg
measure: Overweight
time frame: From entry into the study (baseline: 1997-2009) until 2011
description: Incidence of overweight, on basis of body mass index (BMI), BMI ≥ 24 kg/㎡
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Zhejiang University
investigator full name: Jingjing Jiao
investigator title: Associate Professor
mesh term: Hypertension
mesh term: Diabetes Mellitus
mesh term: Overweight