<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/NCT04475822</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AF2020LSK-003</org_study_id>
    <nct_id>NCT04475822</nct_id>
  </id_info>
  <brief_title>Explore the Effect of Diet Intervention on Lipid Metabolism and Body Mass Index Among the Patients With Metabolic Syndrome</brief_title>
  <official_title>An Intervention Study of Intermittent Fasting and Low Carbon Diet in Patients With Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Leiden University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong University</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 prevalence of metabolic syndrome (MetS) is increasing all over the world, which is&#xD;
      largely related to the increasing obesity population and the current inactive lifestyle of&#xD;
      human beings. It is a common problem facing public health and clinical practice.Metabolic&#xD;
      syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular&#xD;
      disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and&#xD;
      obesity (especially central obesity).Researchers believe that the common pathological basis&#xD;
      of these manifestations is insulin resistance, which is generally considered to be a&#xD;
      reduction in the biological effects of insulin compared with the normal biological effects of&#xD;
      expected biological phenomena.Nowadays, there are more and more studies on insulin resistance&#xD;
      in the world. We have known that age, poor living and eating habits, high blood fat, high&#xD;
      blood sugar and stress all lead to insulin resistance.&#xD;
&#xD;
      The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution&#xD;
      and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the&#xD;
      incidence of chronic diseases in patients with metabolic syndrome through the intervention of&#xD;
      lifestyle and diet habits in the early stage of the disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weight</measure>
    <time_frame>Three months after the intervention</time_frame>
    <description>kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>body fat</measure>
    <time_frame>Three months after the intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>Three months after the intervention</time_frame>
    <description>mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood glucose</measure>
    <time_frame>Three months after the intervention</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood lipid</measure>
    <time_frame>Three months after the intervention</time_frame>
    <description>mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>uric acid</measure>
    <time_frame>Three months after the intervention</time_frame>
    <description>µmol/L</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">169</enrollment>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Intermittent fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low carb diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the definition of low carbon diet given by R. D. Feinman et al. (Nutrition, 2015), the daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low carbon diet and intermittent fasting group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intermittent fasting</intervention_name>
    <description>Intermittent fasting group:During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.</description>
    <arm_group_label>Intermittent fasting</arm_group_label>
    <other_name>Low carb diet</other_name>
    <other_name>Low carbon diet and intermittent fasting group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low carb diet</intervention_name>
    <description>Low carb diet:The daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.</description>
    <arm_group_label>Low carb diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Low carbon diet and intermittent fasting group</intervention_name>
    <description>Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.</description>
    <arm_group_label>Low carbon diet and intermittent fasting group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Diagnosed with metabolic syndrome (i.e., more than 3 abnormal findings out of 5):&#xD;
&#xD;
               1. Waist circumference ≥ 90 cm (men) or ≥ 80 cm (women).&#xD;
&#xD;
               2. Elevated TG (use of medications for elevated TG is an alternate indicator) ≥ 150&#xD;
                  mg/dL (1.7 mmol/L).&#xD;
&#xD;
               3. Reduced HDL-c (use of medications for reduced HDL-c is an alternate indicator) &lt;&#xD;
                  40 mg/dL (1.0 mmol/L) in males &lt; 50 mg/dL (1.3 mmol/L) in females.&#xD;
&#xD;
               4. Elevated blood pressure (use of hypoglycemic medications is an alternate&#xD;
                  indicator). SBP ≥ 130 and/or DBP ≥ 85 mmHg.&#xD;
&#xD;
               5. Elevated FBG (used of hypoglycemic medications is an alternate indicator) ≥ 100&#xD;
                  mg/dL (5.6 mmol/L).&#xD;
&#xD;
          2. Age from 18 to 65 years.&#xD;
&#xD;
          3. Stable weight (change ≤ 10% current body weight) for 3 months prior to the study.&#xD;
&#xD;
          4. If participates were on hypoglycemic medications, hypotensive medications,&#xD;
             lipid-lowering medications and cardiovascular medications, dose adjustment was not&#xD;
             permitted during the 3-month intervention.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Pregnant or breast-feeding.&#xD;
&#xD;
          2. Night shift workers.&#xD;
&#xD;
          3. History of major diseases or related diseases, such as inflammatory disease,&#xD;
             rheumatologic disease, adrenal disease, malignancy, type 1 diabetes, cirrhosis,&#xD;
             chronic kidney disease, acquired immunodeficiency syndrome, eating disorder,&#xD;
             uncontrolled psychiatric disorder and major adverse cardiovascular event.&#xD;
&#xD;
          4. Current participate in other weight-management program, current on a prescribed diet&#xD;
             for special disease or current on any drugs that effect appetite.&#xD;
&#xD;
          5. History of weight-loss surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bingyin Shi</last_name>
    <role>Study Chair</role>
    <affiliation>First Affilicated Hospital of Xian Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Affiliated Hospital of Xi an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Syndrome</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/NCT04475822
org study id: XJTU1AF2020LSK-003
nct id: NCT04475822
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The prevalence of metabolic syndrome (MetS) is increasing all over the world, which is
      largely related to the increasing obesity population and the current inactive lifestyle of
      human beings. It is a common problem facing public health and clinical practice.Metabolic
      syndrome is an accumulation of biologically metabolic risk factors related to cardiovascular
      disease and diabetes, including glucose metabolism disorders, hypertension, dyslipidemia, and
      obesity (especially central obesity).Researchers believe that the common pathological basis
      of these manifestations is insulin resistance, which is generally considered to be a
      reduction in the biological effects of insulin compared with the normal biological effects of
      expected biological phenomena.Nowadays, there are more and more studies on insulin resistance
      in the world. We have known that age, poor living and eating habits, high blood fat, high
      blood sugar and stress all lead to insulin resistance.

      The researchers hope to reduce weight, reduce body fat rate, improve body fat distribution
      and insulin resistance, reverse abnormal metabolic indicators, and ultimately reduce the
      incidence of chronic diseases in patients with metabolic syndrome through the intervention of
      lifestyle and diet habits in the early stage of the disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: weight
time frame: Three months after the intervention
description: kg
measure: body fat
time frame: Three months after the intervention
measure: blood pressure
time frame: Three months after the intervention
description: mmHg
measure: blood glucose
time frame: Three months after the intervention
description: mmol/L
measure: blood lipid
time frame: Three months after the intervention
description: mmol/L
measure: uric acid
time frame: Three months after the intervention
description: µmol/L
arm group label: Intermittent fasting
arm group type: Experimental
description: During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.
arm group label: Low carb diet
arm group type: Experimental
description: According to the definition of low carbon diet given by R. D. Feinman et al. (Nutrition, 2015), the daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.
arm group label: Low carbon diet and intermittent fasting group
arm group type: Experimental
description: Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.
intervention type: Behavioral
intervention name: Intermittent fasting
description: Intermittent fasting group:During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.
arm group label: Intermittent fasting
other name: Low carb diet
other name: Low carbon diet and intermittent fasting group
intervention type: Behavioral
intervention name: Low carb diet
description: Low carb diet:The daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.
arm group label: Low carb diet
intervention type: Behavioral
intervention name: Low carbon diet and intermittent fasting group
description: Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.
arm group label: Low carbon diet and intermittent fasting group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Bingyin Shi
role: Study Chair
affiliation: First Affilicated Hospital of Xian Jiaotong University
facility: 
country: China
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Syndrome