<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/NCT03231618</url>
  </required_header>
  <id_info>
    <org_study_id>ChineseAS-201709</org_study_id>
    <nct_id>NCT03231618</nct_id>
  </id_info>
  <brief_title>The Intervention Study of Dietary Intake on Energy Expenditure</brief_title>
  <official_title>The Intervention Study of Dietary Intake on Energy Expenditure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a randomized crossover (2 × 3) dietary intervention. 40 male volunteers(20&#xD;
      normal weight, 20 overweight / obesity, no other serious disease or metabolic abnormalities)&#xD;
      aged 18-45 years are required to take 3 kinds of isocaloric diets with different amounts of&#xD;
      macronutrients: low-fat high-carbohydrate diets, low-carbohydrate high-fat diets and&#xD;
      high-protein low-fat diets. The comparison is made within subject before and after the test&#xD;
      meal. Each subject takes 6 meals of 3 kinds of diets on 6 separate days with a washout period&#xD;
      between different diets. The study protocol was approved by the Ethics Committee of Shanghai&#xD;
      Institutes for Biological Sciences and all participants provided written informed consents.&#xD;
      The study is the first to investigate among overweight / obesity and normal weight in China&#xD;
      to clarify:&#xD;
&#xD;
        1. the relationship between the proportion of macronutrients in diets and the energy&#xD;
           metabolism efficiency.&#xD;
&#xD;
        2. the main genetic and non-genetic factors that impact individual energy metabolism, the&#xD;
           characteristics of metabolic profiling and relative regulatory pathways.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the largest population of obesity and diabetes, China is suffering from heavy burden of&#xD;
      obesity and major complications such as cardiovascular disease, type 2 diabetes and other&#xD;
      major metabolic diseases ,which have become the major cause of disease death and continued to&#xD;
      endanger the public health. In order to curb the incidence of obesity and its complications,&#xD;
      more effective strategies are required to &quot;prevent the move forward.&quot; With the arrival of&#xD;
      &quot;precise nutrition&quot; era, precise weight management strategy for different sub-groups has&#xD;
      become a hotspot of international research in this field.&#xD;
&#xD;
      Healthy diet and lifestyle are worldwide recognized as the most important and effective ways&#xD;
      of preventing chronic metabolic diseases such as obesity. Recently, different combinations of&#xD;
      macronutrients including &quot;low-fat + high carbon&quot;, &quot;low carbon + high fat&quot;, and &quot;high protein&#xD;
      + low fat&quot; draw much more attention instead of restriction on the total energy intake in the&#xD;
      study of diet weight reduction strategy. However, it is noteworthy that most studies are&#xD;
      focused on groups and conducted on the Western population. Studies of different dietary&#xD;
      structure, genetic background and metabolic phenotypes of energy metabolism are still scarce,&#xD;
      and data of Chinese population are lacking in this field.&#xD;
&#xD;
      This study intends to provide 40 male volunteers aged 20-45 (20 normal weight, 20 overweight&#xD;
      / obesity, no other serious illness or metabolic abnormalities) with three diets with&#xD;
      different levels of macronutrients (low-fat + high-carbon foods, low-carbon + high-fat foods,&#xD;
      and high-protein + low-fat foods) to 1) clarify the relationship between the ratio of&#xD;
      macronutrients in diets and the energy metabolism efficiency; 2) investigate the effect of&#xD;
      major genetic and non-genetic factors (age, obesity, adipose distribution and thyroid&#xD;
      hormone) and metabolomics profiles on individual energy metabolism; 3) explore novel&#xD;
      metabolic regulation networks. Ultimately, this study will provide basic data for discovering&#xD;
      the energy metabolism efficiency of different dietary intervention and major genetic and&#xD;
      non-genetic determinants, metabolic profile characteristics and regulatory pathways.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Quotient</measure>
    <time_frame>1 hour after meal</time_frame>
    <description>Respiratory quotient was measured in a metabolic chamber</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>1 hour after meal</time_frame>
    <description>Heart rate (bpm) was measured by automatic heart rate meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose</measure>
    <time_frame>2 hour after meal</time_frame>
    <description>Blood glucose (mg/dl) was measured using a automatic biochemical analyzer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>2 hour after meal</time_frame>
    <description>Blood triglyceride (mg/dl) was measured using a automatic biochemical analyzer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy and Overweight/ Obesity Males</condition>
  <arm_group>
    <arm_group_label>Normal weight group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 normal-weight males taking 3 types of assigned diets in random orders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Overweight/ obesity group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 overweight/ obesity males taking 3 types of assigned diets in random orders</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet</intervention_name>
    <description>Every participate was provided with 3 types of diets in random order</description>
    <arm_group_label>Normal weight group</arm_group_label>
    <arm_group_label>Overweight/ obesity group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects, aged 18-45 years&#xD;
&#xD;
          -  20 normal weight (18.5≤ BMI&lt;24) and 20 overweight / obesity (BMI ≥24)&#xD;
&#xD;
          -  No participating in other clinical studies within previous 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcoholic (100 grams of alcohol per drink, or 250 grams of rice wine, or 5 bottles of&#xD;
             beer, ≥ 5 times a week)&#xD;
&#xD;
          -  Diabetic patients or the use of insulin, hypoglycemic agents&#xD;
&#xD;
          -  Taking antihypertensive drugs (diuretics, β blockers drugs, etc.) or lipid lowering&#xD;
             drugs (class &quot;bite&quot;, bile acids, statins, etc.) at present or once (within 6 months&#xD;
             before the experiment)&#xD;
&#xD;
          -  Having serious cardiovascular and cerebrovascular diseases at present or before, may&#xD;
             interfere with the normal operation of the experiment (such as heart failure,&#xD;
             myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia,&#xD;
             receiving interventional therapy, etc.)&#xD;
&#xD;
          -  Having severe gastrointestinal diseases that affect food digestion and absorption,&#xD;
             such as severe diarrhea in the past 3 months (3 or more times per day and lasting for&#xD;
             3 days or more); severe constipation in the past 3 months (2 times a week or less,&#xD;
             accompanied by difficulties in defecation)&#xD;
&#xD;
          -  Having received drug treatment over the past 3 months due to the following diseases:&#xD;
             cholecystitis, gastrointestinal ulcers; urinary tract infection, acute pyelonephritis,&#xD;
             cystitis; having undergone any surgery, in addition to appendicitis, hernia surgery;&#xD;
             having taken or taking drugs that will affect the digestion and absorption system&#xD;
&#xD;
          -  Attempting to change weight recently(weight loss, being on a diet, or weight gain)&#xD;
&#xD;
          -  Subjects with severe liver and kidney disease (alanine aminotransferase, serum&#xD;
             creatinine exceeded 1.5 times of the normal range set by the hospital)&#xD;
&#xD;
          -  Subjects with severe thyroid disease (hyperthyroidism or hypothyroidism) or pituitary&#xD;
             disease&#xD;
&#xD;
          -  Subjects with anemia (hemoglobin &lt;120 g per liter)&#xD;
&#xD;
          -  Subjects with cancer or who have received radiotherapy or chemotherapy within five&#xD;
             years&#xD;
&#xD;
          -  Having any mental illness; epilepsy patients or receiving antiepileptic treatment;&#xD;
             using antidepressants&#xD;
&#xD;
          -  Suffering from AIDS, hepatitis A, hepatitis B or other infectious diseases&#xD;
&#xD;
          -  Physical disability&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xu Lin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Nutritional Sciences, Chinese Academy of Sciences</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>January 24, 2018</last_update_submitted>
  <last_update_submitted_qc>January 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Sciences</investigator_affiliation>
    <investigator_full_name>Xu Lin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>dietary intake</keyword>
  <keyword>cross-over intervention</keyword>
  <keyword>energy expenditure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03231618
org study id: ChineseAS-201709
nct id: NCT03231618
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a randomized crossover (2 × 3) dietary intervention. 40 male volunteers(20
      normal weight, 20 overweight / obesity, no other serious disease or metabolic abnormalities)
      aged 18-45 years are required to take 3 kinds of isocaloric diets with different amounts of
      macronutrients: low-fat high-carbohydrate diets, low-carbohydrate high-fat diets and
      high-protein low-fat diets. The comparison is made within subject before and after the test
      meal. Each subject takes 6 meals of 3 kinds of diets on 6 separate days with a washout period
      between different diets. The study protocol was approved by the Ethics Committee of Shanghai
      Institutes for Biological Sciences and all participants provided written informed consents.
      The study is the first to investigate among overweight / obesity and normal weight in China
      to clarify:

        1. the relationship between the proportion of macronutrients in diets and the energy
           metabolism efficiency.

        2. the main genetic and non-genetic factors that impact individual energy metabolism, the
           characteristics of metabolic profiling and relative regulatory pathways.
With the largest population of obesity and diabetes, China is suffering from heavy burden of
      obesity and major complications such as cardiovascular disease, type 2 diabetes and other
      major metabolic diseases ,which have become the major cause of disease death and continued to
      endanger the public health. In order to curb the incidence of obesity and its complications,
      more effective strategies are required to "prevent the move forward." With the arrival of
      "precise nutrition" era, precise weight management strategy for different sub-groups has
      become a hotspot of international research in this field.

      Healthy diet and lifestyle are worldwide recognized as the most important and effective ways
      of preventing chronic metabolic diseases such as obesity. Recently, different combinations of
      macronutrients including "low-fat + high carbon", "low carbon + high fat", and "high protein
      + low fat" draw much more attention instead of restriction on the total energy intake in the
      study of diet weight reduction strategy. However, it is noteworthy that most studies are
      focused on groups and conducted on the Western population. Studies of different dietary
      structure, genetic background and metabolic phenotypes of energy metabolism are still scarce,
      and data of Chinese population are lacking in this field.

      This study intends to provide 40 male volunteers aged 20-45 (20 normal weight, 20 overweight
      / obesity, no other serious illness or metabolic abnormalities) with three diets with
      different levels of macronutrients (low-fat + high-carbon foods, low-carbon + high-fat foods,
      and high-protein + low-fat foods) to 1) clarify the relationship between the ratio of
      macronutrients in diets and the energy metabolism efficiency; 2) investigate the effect of
      major genetic and non-genetic factors (age, obesity, adipose distribution and thyroid
      hormone) and metabolomics profiles on individual energy metabolism; 3) explore novel
      metabolic regulation networks. Ultimately, this study will provide basic data for discovering
      the energy metabolism efficiency of different dietary intervention and major genetic and
      non-genetic determinants, metabolic profile characteristics and regulatory pathways.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Respiratory Quotient
time frame: 1 hour after meal
description: Respiratory quotient was measured in a metabolic chamber
measure: Heart Rate
time frame: 1 hour after meal
description: Heart rate (bpm) was measured by automatic heart rate meter
measure: Glucose
time frame: 2 hour after meal
description: Blood glucose (mg/dl) was measured using a automatic biochemical analyzer
measure: Triglyceride
time frame: 2 hour after meal
description: Blood triglyceride (mg/dl) was measured using a automatic biochemical analyzer
arm group label: Normal weight group
arm group type: Experimental
description: 20 normal-weight males taking 3 types of assigned diets in random orders
arm group label: Overweight/ obesity group
arm group type: Experimental
description: 20 overweight/ obesity males taking 3 types of assigned diets in random orders
intervention type: Dietary Supplement
intervention name: 1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet
description: Every participate was provided with 3 types of diets in random order
arm group label: Normal weight group
arm group label: Overweight/ obesity group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xu Lin
role: Principal Investigator
affiliation: Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Sciences
investigator full name: Xu Lin
investigator title: Principal Investigator
mesh term: Overweight
sharing ipd: Undecided