<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/NCT03031886</url>
  </required_header>
  <id_info>
    <org_study_id>2015/01085</org_study_id>
    <nct_id>NCT03031886</nct_id>
  </id_info>
  <brief_title>Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods</brief_title>
  <official_title>Energy Flux and Fat Oxidation Using Low and High Glycaemic Index Foods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinical Nutrition Research Centre, Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinical Nutrition Research Centre, Singapore</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>
      Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose&#xD;
      profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The GI is a method of classifying foods based on the food's ability to raise the blood&#xD;
      glucose level. Low GI foods are recommended as they have a lower impact on blood glucose&#xD;
      concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose&#xD;
      profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese&#xD;
      males will be recruited. There will be two sessions (consisting of three days for each&#xD;
      session) where they will consume either a high or low glycaemic index dinner at home and a&#xD;
      high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter).&#xD;
      There will be at least five days in between the two sessions. Their glycaemic response will&#xD;
      be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while&#xD;
      substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch&#xD;
      and snack). This study specifically attempts to see whether the inclusion of a low GI&#xD;
      sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in&#xD;
      Asians. The study is important in that it will enable us to compute the rate of fat oxidation&#xD;
      and how it is influenced when subjects are fed a mixed meals modulated to be high GI&#xD;
      (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians.&#xD;
      Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is&#xD;
      no exception. Devising ways and means to staunch the escalation is therefore a priority. The&#xD;
      findings of the research will contribute towards the long-term objectives of developing&#xD;
      dietary guidelines for weight and glycaemic control. The study data will also be important&#xD;
      for the provision of practical food-based advocacy for better weight and glycaemic control in&#xD;
      Asians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2016</start_date>
  <completion_date type="Actual">July 21, 2017</completion_date>
  <primary_completion_date type="Actual">July 21, 2017</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>
    <intervention_model_description>A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double blinded, subjects was blinded from knowing if foods were low or high GI, researchers analyzing the data were blinded from food preparation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Glycaemic response</measure>
    <time_frame>3 hours post consumption</time_frame>
    <description>The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily blood glucose profile</measure>
    <time_frame>24 hours</time_frame>
    <description>The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>substrate oxidation</measure>
    <time_frame>3 hours post consumption</time_frame>
    <description>Carbohydrate, fat and protein oxidation and respiratory quotient after consumption of low and high GI test foods are calculated for the 3 hours postprandial after breakfast, lunch and snack. These are calculated from the oxygen consumption, carbon dioxide production and nitrogen production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production, nitrogen production.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>energy expenditure</measure>
    <time_frame>3 hours post consumption</time_frame>
    <description>Energy expenditure after consumption of low and high GI test foods is calculated for the 3 hours postprandial after breakfast, lunch and snack. This is calculated from the oxygen consumption and carbon dioxide production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Oxygen consumption</measure>
    <time_frame>3 hours post consumption</time_frame>
    <description>Oxygen consumption after consumption of low and high GI test foods measured 3 hours postprandial using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only.</description>
  </other_outcome>
  <other_outcome>
    <measure>carbon dioxide production</measure>
    <time_frame>3 hours post consumption</time_frame>
    <description>Carbon dioxide production after consumption of low and high GI test foods measured 3 hours postprandial using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nitrogen production</measure>
    <time_frame>10 hours</time_frame>
    <description>Nitrogen production during 10 hours in the whole body calorimeter is measured from all urine collected during the stay in the whole body calorimeter when consuming low and high GI test foods</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type 2 Diabetes</condition>
  <condition>Obesity</condition>
  <condition>PreDiabetes</condition>
  <arm_group>
    <arm_group_label>high GI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low GI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>low glycaemic index intervention</intervention_name>
    <description>Low GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack.</description>
    <arm_group_label>Low GI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>high glycaemic index intervention</intervention_name>
    <description>High GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack.</description>
    <arm_group_label>high GI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chinese, male&#xD;
&#xD;
          -  Age between 21-40 years&#xD;
&#xD;
          -  Body mass index between 17 to 28 kg/m2&#xD;
&#xD;
          -  Normal blood pressure (&lt;140/80 Hgmm)&#xD;
&#xD;
          -  Fasting blood glucose &lt; 6 mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having any metabolic diseases (such as diabetes, hypertension etc)&#xD;
&#xD;
          -  One prescription medication&#xD;
&#xD;
          -  Partaking in sports at the competitive and/or endurance levels&#xD;
&#xD;
          -  Allergic/intolerant to any of the test foods&#xD;
&#xD;
          -  Intentionally restricting food intake&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>men only</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Nutrition Research Centre</name>
      <address>
        <city>Singapore</city>
        <zip>117599</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Nutrition Research Centre, Singapore</investigator_affiliation>
    <investigator_full_name>JeyaKumar Henry</investigator_full_name>
    <investigator_title>Principal Investogator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03031886
org study id: 2015/01085
nct id: NCT03031886
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose: This study is carried out to determine the effect of GI on 24 hour blood glucose
      profiles and energy regulation in Asians when fed a normal diet modulated with sweeteners.
The GI is a method of classifying foods based on the food's ability to raise the blood
      glucose level. Low GI foods are recommended as they have a lower impact on blood glucose
      concentrations. The research sets out to determine the effect of GI on 24 hour blood glucose
      profiles and energy regulation in Asians. Healthy, normal-weight and overweight, Chinese
      males will be recruited. There will be two sessions (consisting of three days for each
      session) where they will consume either a high or low glycaemic index dinner at home and a
      high or low GI breakfast, lunch and snack on the next day (in the whole body calorimeter).
      There will be at least five days in between the two sessions. Their glycaemic response will
      be measured using a Continuous Glucose Monitoring System (CGMS) throughout the period, while
      substrate oxidation will be measured over 10 hours in the calorimeter (from breakfast, lunch
      and snack). This study specifically attempts to see whether the inclusion of a low GI
      sweetener in a mixed meal sequence can impact blood glucose levels and energy regulation in
      Asians. The study is important in that it will enable us to compute the rate of fat oxidation
      and how it is influenced when subjects are fed a mixed meals modulated to be high GI
      (increased glucose excursions) or low GI (moderated glucose) over 24 hours in healthy Asians.
      Obesity and diabetes rates are increasing exponentially in Asian populations and Singapore is
      no exception. Devising ways and means to staunch the escalation is therefore a priority. The
      findings of the research will contribute towards the long-term objectives of developing
      dietary guidelines for weight and glycaemic control. The study data will also be important
      for the provision of practical food-based advocacy for better weight and glycaemic control in
      Asians.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: A randomized,crossover design with either a low or high GI diet with a 5 day washout period in between the 2 interventions..
primary purpose: Other
masking: Double (Participant, Investigator)
masking description: Double blinded, subjects was blinded from knowing if foods were low or high GI, researchers analyzing the data were blinded from food preparation.
measure: Glycaemic response
time frame: 3 hours post consumption
description: The blood glucose response to low and high GI test foods measured 2 hours post consumption using the Continuous Glucose Monitoring System (CGMS)
measure: Daily blood glucose profile
time frame: 24 hours
description: The daily total blood glucose response is measured for each low and high GI treatment as the area under the curve over 24 hours using CGMS for breakfast, lunch, snack and dinner.
measure: substrate oxidation
time frame: 3 hours post consumption
description: Carbohydrate, fat and protein oxidation and respiratory quotient after consumption of low and high GI test foods are calculated for the 3 hours postprandial after breakfast, lunch and snack. These are calculated from the oxygen consumption, carbon dioxide production and nitrogen production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production, nitrogen production.
measure: energy expenditure
time frame: 3 hours post consumption
description: Energy expenditure after consumption of low and high GI test foods is calculated for the 3 hours postprandial after breakfast, lunch and snack. This is calculated from the oxygen consumption and carbon dioxide production. These sub-measurements are specified under: Other Pre-specified Outcomes: Oxygen consumption, carbon dioxide production.
measure: Oxygen consumption
time frame: 3 hours post consumption
description: Oxygen consumption after consumption of low and high GI test foods measured 3 hours postprandial using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only.
measure: carbon dioxide production
time frame: 3 hours post consumption
description: Carbon dioxide production after consumption of low and high GI test foods measured 3 hours postprandial using indirect calorimetry in a whole body calorimeter. This is done over 10 hours in the whole body calorimeter measured for breakfast, lunch and snack only.
measure: Nitrogen production
time frame: 10 hours
description: Nitrogen production during 10 hours in the whole body calorimeter is measured from all urine collected during the stay in the whole body calorimeter when consuming low and high GI test foods
arm group label: high GI
arm group type: Experimental
description: Cereal, milk, tea, cheese, steamed glutinous rice with chicken, carrots, bread, strawberry jam, margarine, high GI sweetener (sucrose).
arm group label: Low GI
arm group type: Experimental
description: Cereal, milk, tea, steamed basmati rice with chicken, spinach, bread, strawberry jam, low GI sweetener (isomaltulose).
intervention type: Other
intervention name: low glycaemic index intervention
description: Low GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack.
arm group label: Low GI
intervention type: Other
intervention name: high glycaemic index intervention
description: High GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack.
arm group label: high GI
criteria: 
gender: Male
gender based: Yes
gender description: men only
minimum age: 21 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Clinical Nutrition Research Centre, Singapore
investigator full name: JeyaKumar Henry
investigator title: Principal Investogator
mesh term: Prediabetic State
sharing ipd: No