xml: <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/NCT05977244</url>
    </required_header>
    <id_info>
      <org_study_id>PD233/18</org_study_id>
      <nct_id>NCT05977244</nct_id>
    </id_info>
    <brief_title>Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model</brief_title>
    <official_title>Exploring the Effects of Varying Fat:Carbohydrate Diet Permutations on Gastric Emptying and Metabolic Status Using Human Postprandial Model</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Malaysia Palm Oil Board</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Taylor's University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National University of Malaysia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Malaysia Palm Oil Board</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>
        The aim of this clinical trial is to investigate the effects of the meals moderated by fat&#xD;
        and carbohydrate (CHO) quality along with varying macronutrient distribution (CHO: fat) on&#xD;
        gut physiology and metabolic outcomes using the human postprandial model with healthy&#xD;
        subjects.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          1. How does meal composition with different polyunsaturated/saturated (P/S) ratio, glycemic&#xD;
             index and macronutrient quantity affect lipemia and glycemia?&#xD;
  &#xD;
          2. How does meal composition with different P/S ratio, Glycemic index and macronutrient&#xD;
             quantity affect gastric emptying?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study's objectives will be tested via a randomized, crossover study with 16 diet&#xD;
        rotations separated by minimum one week washout period. All recruited subjects will be&#xD;
        randomly assigned into 2 groups of 7 each namely HGI and LGI with 9 diet rotations within&#xD;
        each group. The study design will be a cross-over trial with the same subjects undergoing all&#xD;
        arms of the diet rotations. The subjects will be blinded to the test fats used for each&#xD;
        rotation. Body weight measurements will be recorded before each postprandial challenge to&#xD;
        minimise weight fluctuations between the test rotations.&#xD;
  &#xD;
        Study procedures&#xD;
  &#xD;
          1. Oral glucose tolerance test (OGTT) Sessions&#xD;
  &#xD;
             Prior and end of the test meal rotations, subjects will undergo oral glucose tolerance&#xD;
             test (OGTT) with a glucose reference drink at 2 random sessions without MRI&#xD;
             investigation at Taylor's University or Hospital Cancelor Tuanku Muhriz (HCTM), to get&#xD;
             an average value for the plasma glucose and insulin standards for each subject. The&#xD;
             glucose reference drink composition will be 50g of anhydrous glucose mixed with 250mL of&#xD;
             room temperature water. Blood samples will be collected sequentially at 0, 15, 30, 60,&#xD;
             90,120 and 180 minutes.&#xD;
  &#xD;
          2. Test meal sessions&#xD;
  &#xD;
        During each postprandial test meal rotations, subjects will consume test meals followed by&#xD;
        MRI scans at the MRI center at Hospital Cancelor Tuanku Muhriz(HCTM). For scheduled session,&#xD;
        Subjects will be advised to refrain from strenuous physical activity, high calorie or&#xD;
        fast-food, supplements and coffee intake for 24 hours preceding each postprandial event.&#xD;
        Subjects will be at the clinical center at 7:30 and 8:30a.m, following a 12-hour overnight&#xD;
        fast. Upon arrival at the centre,subjects will rest for 10min, followed by body weight, blood&#xD;
        pressure and self-monitoring of blood glucose (SBMG) measurements. Subsequently, blood&#xD;
        samples will be drawn for metabolic investigations as per study objectives. Sequential&#xD;
        postprandial MRI scans before and after test meal intake at 0(fasting), 15, 30, 60, 90, 120,&#xD;
        180, 240 and 300 minutes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 21, 2022</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Lipemia</measure>
      <time_frame>0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals</time_frame>
      <description>To determine the postprandial changes in triacylglyceride (TAG)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glycemia</measure>
      <time_frame>0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals</time_frame>
      <description>To determine the postprandial changes of glucose</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Gastric emptying</measure>
      <time_frame>0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals</time_frame>
      <description>To determine the postprandial changes in half emptying time</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gut hormone</measure>
      <time_frame>0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals</time_frame>
      <description>To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP)</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">14</enrollment>
    <condition>Postprandial Lipemia</condition>
    <condition>Postprandial Glycemia</condition>
    <condition>Gastric Emptying</condition>
    <arm_group>
      <arm_group_label>HGI+palm olein</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 portion of HGI(high glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HGI+soy bean oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 portion of HGI (high glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LGI+palm olein</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 portion of LGI (low glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LGI+soy bean oil</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1 portion of LGI (low glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>HGI+palm olein</intervention_name>
      <description>A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.</description>
      <arm_group_label>HGI+palm olein</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>LGI+palm olein</intervention_name>
      <description>A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.</description>
      <arm_group_label>LGI+palm olein</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>HGI+soy bean oil</intervention_name>
      <description>A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.</description>
      <arm_group_label>HGI+soy bean oil</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>LGI+soy bean oil</intervention_name>
      <description>A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.</description>
      <arm_group_label>LGI+soy bean oil</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Healthy subjects, (n=12-14) without history of chronic disease(s) with body mass index&#xD;
          (BMI) between 18.5-25.0 kg/m2 and normal fasting blood glucose status [&lt;5.4 mmol/L] will be&#xD;
          enrolled into the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Using pharmacotherapy that interferes with lipid and glucose metabolism or&#xD;
               gastrointestinal transit (constipating drugs) or on oral contraceptives (women).&#xD;
  &#xD;
            2. Underweight body mass index (BMI): &lt; 18.5 kg/m2&#xD;
  &#xD;
            3. With medical history of cardiovascular disease (CVD), Diabetes Mellitus, dyslipidemia&#xD;
               and other chronic diseases,&#xD;
  &#xD;
            4. acute or chronic gastrointestinal illness&#xD;
  &#xD;
            5. If vulnerable to claustrophobia or anxiety&#xD;
  &#xD;
            6. Regular alcohol usage&#xD;
  &#xD;
            7. On low-calorie diets&#xD;
  &#xD;
            8. Smoking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gowri Nagapan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Malaysia Palm Oil Board</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gowri Ms Nagapan, MSc</last_name>
      <phone>0126673592</phone>
      <email>gowri@mpob.gov.my</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Teng Dr Kim Tiu, PhD</last_name>
      <email>kimtiu@mpob.gov.my</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Malaysian Palm Oil Board</name>
        <address>
          <city>Kajang</city>
          <state>Selangor</state>
          <zip>43000</zip>
          <country>Malaysia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gowri Nagapan, MSc</last_name>
        <phone>0126673592</phone>
        <email>gowri@mpob.gov.my</email>
      </contact>
    </location>
    <location_countries>
      <country>Malaysia</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>meal composition</keyword>
    <keyword>P/S ratio</keyword>
    <keyword>macronutrient distribution</keyword>
    <keyword>glycemic index</keyword>
    <keyword>glycemia</keyword>
    <keyword>lipemia</keyword>
    <keyword>gut hormones</keyword>
    <keyword>gastric emptying</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperlipidemias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977244
  org study id: PD233/18
  nct id: NCT05977244
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this clinical trial is to investigate the effects of the meals moderated by fat
        and carbohydrate (CHO) quality along with varying macronutrient distribution (CHO: fat) on
        gut physiology and metabolic outcomes using the human postprandial model with healthy
        subjects.
  
        The main question[s] it aims to answer are:
  
          1. How does meal composition with different polyunsaturated/saturated (P/S) ratio, glycemic
             index and macronutrient quantity affect lipemia and glycemia?
  
          2. How does meal composition with different P/S ratio, Glycemic index and macronutrient
             quantity affect gastric emptying?
  The study's objectives will be tested via a randomized, crossover study with 16 diet
        rotations separated by minimum one week washout period. All recruited subjects will be
        randomly assigned into 2 groups of 7 each namely HGI and LGI with 9 diet rotations within
        each group. The study design will be a cross-over trial with the same subjects undergoing all
        arms of the diet rotations. The subjects will be blinded to the test fats used for each
        rotation. Body weight measurements will be recorded before each postprandial challenge to
        minimise weight fluctuations between the test rotations.
  
        Study procedures
  
          1. Oral glucose tolerance test (OGTT) Sessions
  
             Prior and end of the test meal rotations, subjects will undergo oral glucose tolerance
             test (OGTT) with a glucose reference drink at 2 random sessions without MRI
             investigation at Taylor's University or Hospital Cancelor Tuanku Muhriz (HCTM), to get
             an average value for the plasma glucose and insulin standards for each subject. The
             glucose reference drink composition will be 50g of anhydrous glucose mixed with 250mL of
             room temperature water. Blood samples will be collected sequentially at 0, 15, 30, 60,
             90,120 and 180 minutes.
  
          2. Test meal sessions
  
        During each postprandial test meal rotations, subjects will consume test meals followed by
        MRI scans at the MRI center at Hospital Cancelor Tuanku Muhriz(HCTM). For scheduled session,
        Subjects will be advised to refrain from strenuous physical activity, high calorie or
        fast-food, supplements and coffee intake for 24 hours preceding each postprandial event.
        Subjects will be at the clinical center at 7:30 and 8:30a.m, following a 12-hour overnight
        fast. Upon arrival at the centre,subjects will rest for 10min, followed by body weight, blood
        pressure and self-monitoring of blood glucose (SBMG) measurements. Subsequently, blood
        samples will be drawn for metabolic investigations as per study objectives. Sequential
        postprandial MRI scans before and after test meal intake at 0(fasting), 15, 30, 60, 90, 120,
        180, 240 and 300 minutes.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Lipemia
  time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
  description: To determine the postprandial changes in triacylglyceride (TAG)
  measure: Glycemia
  time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
  description: To determine the postprandial changes of glucose
  measure: Gastric emptying
  time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
  description: To determine the postprandial changes in half emptying time
  measure: Gut hormone
  time frame: 0, 15, 30, 60, 90, 120, 180, 240, 300minutes after ingestion of test meals
  description: To determine the postprandial changes of glucose-dependent insulinotropic polypeptide (GIP)
  arm group label: HGI+palm olein
  arm group type: Experimental
  description: 1 portion of HGI(high glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.
  arm group label: HGI+soy bean oil
  arm group type: Experimental
  description: 1 portion of HGI (high glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.
  arm group label: LGI+palm olein
  arm group type: Experimental
  description: 1 portion of LGI (low glycemic index) fried rice, fried with palm olein will be served together with 250 milliliter of plain water.
  arm group label: LGI+soy bean oil
  arm group type: Experimental
  description: 1 portion of LGI (low glycemic index) fried rice, fried with soybean oil will be served together with 250 milliliter of plain water.
  intervention type: Other
  intervention name: HGI+palm olein
  description: A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
  arm group label: HGI+palm olein
  intervention type: Other
  intervention name: LGI+palm olein
  description: A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
  arm group label: LGI+palm olein
  intervention type: Other
  intervention name: HGI+soy bean oil
  description: A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
  arm group label: HGI+soy bean oil
  intervention type: Other
  intervention name: LGI+soy bean oil
  description: A 5-hour postprandial feeding intervention with 1-weeks washout in between. Blood samples will be collected at 0 hour (baseline) and up to 5 hours after consumption of test meal.
  arm group label: LGI+soy bean oil
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gowri Nagapan
  role: Principal Investigator
  affiliation: Malaysia Palm Oil Board
  last name: Gowri Ms Nagapan, MSc
  phone: 0126673592
  email: gowri@mpob.gov.my
  last name: Teng Dr Kim Tiu, PhD
  email: kimtiu@mpob.gov.my
  facility: 
  status: Recruiting
  contact: 
  country: Malaysia
  responsible party type: Sponsor
  mesh term: Hyperlipidemias
  sharing ipd: No