<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/NCT03279107</url>
  </required_header>
  <id_info>
    <org_study_id>2017/00428</org_study_id>
    <nct_id>NCT03279107</nct_id>
  </id_info>
  <brief_title>Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.</brief_title>
  <official_title>Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JeyaKumar Henry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tate and Lyle Ingredients France</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      The aim of the study is to describe the glycemic, insulinemic and appetitive responses to&#xD;
      liquid and solid foods where either soluble fiber or maltodextrin are used as the&#xD;
      carbohydrate substrate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Asia has the unenviable reputation as being the epicenter for type 2 diabetes. The Asian&#xD;
      phenotype has been shown to be most susceptible to diabetes than Caucasians. More&#xD;
      importantly, the transition from prediabetes to diabetes is more drastic and severe in&#xD;
      Asians. The glycemic index (GI) was first introduced in 1981 as a classification of the blood&#xD;
      glucose raising potential of carbohydrate foods. There is substantial evidence suggesting&#xD;
      that consumption of low glycemic index (GI) foods minimize blood glucose fluctuations, and&#xD;
      help in the prevention and management of diabetes and prediabetes. Given the rising incidence&#xD;
      of prediabetes and diabetes in Asia, dietary interventions to complement pharmacological&#xD;
      management of diabetes are increasingly being encouraged. The majority of studies on GI and&#xD;
      Glycemic Response (GR) have been conducted on Caucasian populations. Asians have been shown&#xD;
      to have a greater GR to the same food compared to Caucasians. Simple dietary modification&#xD;
      such as increasing dietary fiber in a food has been shown to reduce GR. However, it is&#xD;
      unclear if a palatable, low-viscous, soluble fiber and maltodextrin have comparable effect.&#xD;
      Although viscous insoluble fiber has been shown to also suppress appetite, it was unclear if&#xD;
      similar effects could be obtained when it is replaced with soluble fiber. Using the&#xD;
      continuous glucose monitoring system (CGMS), Henry and his colleagues have demonstrated that&#xD;
      exchanging high-GI bread with a low-GI bread could improve the 24h glucose profile. More&#xD;
      recently investigators have shown, using the CGMS, that the consumption of a low GI breakfast&#xD;
      and afternoon snack was capable of attenuating 24-hour blood glucose profiles, minimizing&#xD;
      glycemic excursions and reducing food intake in healthy Asian males. These simple dietary&#xD;
      interventions appear to be an acceptable approach in improving overall glycemia and energy&#xD;
      balance in Asians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">July 21, 2020</completion_date>
  <primary_completion_date type="Actual">July 21, 2020</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>randomized</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Single Participant</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).</measure>
    <time_frame>up to 180 minutes</time_frame>
    <description>Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).</measure>
    <time_frame>up to 180 minutes</time_frame>
    <description>Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).</measure>
    <time_frame>up to 180 minutes</time_frame>
    <description>Appetite ratings measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Pre Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Control beverage with glucose powder</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard glucose beverage with 50 g of glucose powder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beverage with soluble corn fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beverage with soluble corn fiber (50 gram of total carbohydrate)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Beverage with maltodextrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Beverage with maltodextrin (50 gram of total carbohydrate)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Snack with soluble corn fiber</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>snack with soluble corn fiber (50 gram of total carbohydrate)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Snack with maltodextrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Snack with maltodextrin (50 gram of total carbohydrate)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Soluble corn fiber</intervention_name>
    <description>soluble corn fiber</description>
    <arm_group_label>Beverage with soluble corn fiber</arm_group_label>
    <arm_group_label>Snack with soluble corn fiber</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>maltodextrin</intervention_name>
    <description>maltodextrin</description>
    <arm_group_label>Beverage with maltodextrin</arm_group_label>
    <arm_group_label>Snack with maltodextrin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Chinese male subjects aged between 21 and 60 years&#xD;
&#xD;
          -  Either one of the three criteria:&#xD;
&#xD;
          -  Normal weight (body mass index 18.5-22.9 kg/m2) and Fasting Blood Glucose&#xD;
             5.0-6.0mmol/L&#xD;
&#xD;
          -  Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose 5.0-6.0mmol/L&#xD;
&#xD;
          -  Overweight (body mass index 23.0 - 30.0 kg/m2) and Fasting Blood Glucose &lt;5.0mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do smoke&#xD;
&#xD;
          -  Have any metabolic diseases (such as diabetes, hypertension etc)&#xD;
&#xD;
          -  Have known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency)&#xD;
&#xD;
          -  Have medical conditions and/or taking medications known to affect glycemia&#xD;
             (glucocorticoids, thyroid hormones, thiazide diuretics)&#xD;
&#xD;
          -  Have any major organ dysfunction (e.g. cardiovascular, respiratory, hepatic, renal,&#xD;
             gastrointestinal) that may influence taste, olfaction, appetite, digestion,&#xD;
             metabolism, absorption or elimination of test foods, nutraceutical or drug&#xD;
&#xD;
          -  Consume fiber supplements or other supplements that is likely to interfere with study&#xD;
             outcomes&#xD;
&#xD;
          -  Have any severe food allergy (e.g. anaphylaxis to peanuts)&#xD;
&#xD;
          -  Have any known allergies to any food components of the study protocol&#xD;
&#xD;
          -  Have active Tuberculosis (TB) or currently receiving treatment for TB&#xD;
&#xD;
          -  Have any known Chronic infection or known to suffer from or have previously suffered&#xD;
             from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human&#xD;
             Immunodeficiency Virus (HIV)&#xD;
&#xD;
          -  Is a study team member or an immediate family of any study team member. Immediate&#xD;
             family member is defined as a spouse, parent, child, or sibling, whether biological or&#xD;
             legally adopted.&#xD;
&#xD;
          -  Is enrolled in a concurrent research study judged not to be scientifically or&#xD;
             medically compatible with the study of the CNRC.&#xD;
&#xD;
          -  Partake in sports at the competitive and/or endurance levels&#xD;
&#xD;
          -  Intentionally restrict food intake&#xD;
&#xD;
          -  Have poor veins impeding venous access&#xD;
&#xD;
          -  Have any history of severe vasovagal syncope (blackouts or near faints) following&#xD;
             blood draws&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>healthy male</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 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>August 2021</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>August 19, 2021</last_update_submitted>
  <last_update_submitted_qc>August 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Clinical Nutrition Research Centre, Singapore</investigator_affiliation>
    <investigator_full_name>JeyaKumar Henry</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT03279107
org study id: 2017/00428
nct id: NCT03279107
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to describe the glycemic, insulinemic and appetitive responses to
      liquid and solid foods where either soluble fiber or maltodextrin are used as the
      carbohydrate substrate.
Asia has the unenviable reputation as being the epicenter for type 2 diabetes. The Asian
      phenotype has been shown to be most susceptible to diabetes than Caucasians. More
      importantly, the transition from prediabetes to diabetes is more drastic and severe in
      Asians. The glycemic index (GI) was first introduced in 1981 as a classification of the blood
      glucose raising potential of carbohydrate foods. There is substantial evidence suggesting
      that consumption of low glycemic index (GI) foods minimize blood glucose fluctuations, and
      help in the prevention and management of diabetes and prediabetes. Given the rising incidence
      of prediabetes and diabetes in Asia, dietary interventions to complement pharmacological
      management of diabetes are increasingly being encouraged. The majority of studies on GI and
      Glycemic Response (GR) have been conducted on Caucasian populations. Asians have been shown
      to have a greater GR to the same food compared to Caucasians. Simple dietary modification
      such as increasing dietary fiber in a food has been shown to reduce GR. However, it is
      unclear if a palatable, low-viscous, soluble fiber and maltodextrin have comparable effect.
      Although viscous insoluble fiber has been shown to also suppress appetite, it was unclear if
      similar effects could be obtained when it is replaced with soluble fiber. Using the
      continuous glucose monitoring system (CGMS), Henry and his colleagues have demonstrated that
      exchanging high-GI bread with a low-GI bread could improve the 24h glucose profile. More
      recently investigators have shown, using the CGMS, that the consumption of a low GI breakfast
      and afternoon snack was capable of attenuating 24-hour blood glucose profiles, minimizing
      glycemic excursions and reducing food intake in healthy Asian males. These simple dietary
      interventions appear to be an acceptable approach in improving overall glycemia and energy
      balance in Asians.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: randomized
primary purpose: Other
masking: Single (Participant)
masking description: Single Participant
measure: Change in plasma blood glucose from fasting baseline value (Time Frame: Up to 180 minutes).
time frame: up to 180 minutes
description: Blood plasma glucose measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
measure: Change in plasma blood insulin from fasting baseline value (Time Frame: Up to 180 minutes).
time frame: up to 180 minutes
description: Blood plasma insulin measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
measure: Change in subjective appetite ratings from fasting baseline value (Time Frame: Up to 180 minutes).
time frame: up to 180 minutes
description: Appetite ratings measured at 0, 15, 30, 45, 60, 90, 120, 150 and 180mins after meal ingestion.
arm group label: Control beverage with glucose powder
arm group type: No Intervention
description: Standard glucose beverage with 50 g of glucose powder
arm group label: Beverage with soluble corn fiber
arm group type: Experimental
description: Beverage with soluble corn fiber (50 gram of total carbohydrate)
arm group label: Beverage with maltodextrin
arm group type: Experimental
description: Beverage with maltodextrin (50 gram of total carbohydrate)
arm group label: Snack with soluble corn fiber
arm group type: Experimental
description: snack with soluble corn fiber (50 gram of total carbohydrate)
arm group label: Snack with maltodextrin
arm group type: Experimental
description: Snack with maltodextrin (50 gram of total carbohydrate)
intervention type: Other
intervention name: Soluble corn fiber
description: soluble corn fiber
arm group label: Beverage with soluble corn fiber
arm group label: Snack with soluble corn fiber
intervention type: Other
intervention name: maltodextrin
description: maltodextrin
arm group label: Beverage with maltodextrin
arm group label: Snack with maltodextrin
criteria: 
gender: Male
gender based: Yes
gender description: healthy male
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Singapore
responsible party type: Sponsor-Investigator
investigator affiliation: Clinical Nutrition Research Centre, Singapore
investigator full name: JeyaKumar Henry
investigator title: Principal Investigator
mesh term: Prediabetic State
sharing ipd: No