<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/NCT04462016</url>
  </required_header>
  <id_info>
    <org_study_id>MDP20505_2017/2018_MS0001</org_study_id>
    <nct_id>NCT04462016</nct_id>
  </id_info>
  <brief_title>Effects of Calamansi on Blood Glucose</brief_title>
  <official_title>Blood Glucose Response to a Calamansi Drink in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Malaysia Sarawak</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Malaysia Sarawak</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>
      It is important to bring the blood glucose levels of those with type 2 diabetes mellitus&#xD;
      (T2DM) back to normal levels as this can stop the condition from worsening and prevent other&#xD;
      conditions that are related to T2DM from developing. One way to maintain healthy blood&#xD;
      glucose level is the use of the glycaemic index (GI), which ranks food according to how the&#xD;
      body responds to its carbohydrate content. Low GI foods corresponds to low increase in blood&#xD;
      glucose levels. Calamansi is a citrus that is believed not to induce an increase in blood&#xD;
      glucose levels. Since beverages from calamansi are available and diabetes is a health concern&#xD;
      in the community, it is important to investigate the effect of consuming this drink. Finger&#xD;
      prick blood were tested in order to obtain the blood glucose levels for calculating the GI&#xD;
      for the calamansi drink.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2, 2018</start_date>
  <completion_date type="Actual">August 8, 2018</completion_date>
  <primary_completion_date type="Actual">May 6, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline blood glucose levels</measure>
    <time_frame>30, 60, 90, 120 min after drinking</time_frame>
    <description>Capillary blood glucose using glucometer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline urinary glucose levels</measure>
    <time_frame>30, 60, 90, 120 min after drinking</time_frame>
    <description>Dipstick test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Blood Glucose Response</condition>
  <arm_group>
    <arm_group_label>Reference drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy volunteers' blood glucose response to reference drink (glucose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test drink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy volunteers' blood glucose response to test drink (calamansi)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Calamansi</intervention_name>
    <description>250 ml of a commercially sourced calamansi drink</description>
    <arm_group_label>Test drink</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glucose</intervention_name>
    <description>75 g of glucose dissolved in 250 ml of drinking water</description>
    <arm_group_label>Reference drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  non-smoker&#xD;
&#xD;
          -  BMI between 18.5 and 24.99 kg/m2&#xD;
&#xD;
          -  waist circumference less than 102 cm&#xD;
&#xD;
          -  random blood glucose less than 7.8 mmol/L&#xD;
&#xD;
          -  negative urine dipstick result&#xD;
&#xD;
          -  not on any medications&#xD;
&#xD;
          -  no family history of inherited diseases&#xD;
&#xD;
          -  no heart conditions (angina, arrhythmia or heart failure)&#xD;
&#xD;
          -  no history of acute medical or surgical event within the past 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pre-existing conditions such as HIV, hepatitis, inflammatory bowel diseases, diabetes&#xD;
             mellitus, kidney disease, blood disorders (such as thalassaemia)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Siner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiti Malaysia Sarawak</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine and Health Sciences</name>
      <address>
        <city>Kuching</city>
        <state>Sarawak</state>
        <zip>94300</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>calamansi</keyword>
  <keyword>glycaemic index</keyword>
  <keyword>post-prandial blood glucose</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>This will be made available starting 6 months from the date of publication; for the next 5 years.</ipd_time_frame>
    <ipd_access_criteria>Through reasonable request to the corresponding author.</ipd_access_criteria>
  </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/NCT04462016
org study id: MDP20505_2017/2018_MS0001
nct id: NCT04462016
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is important to bring the blood glucose levels of those with type 2 diabetes mellitus
      (T2DM) back to normal levels as this can stop the condition from worsening and prevent other
      conditions that are related to T2DM from developing. One way to maintain healthy blood
      glucose level is the use of the glycaemic index (GI), which ranks food according to how the
      body responds to its carbohydrate content. Low GI foods corresponds to low increase in blood
      glucose levels. Calamansi is a citrus that is believed not to induce an increase in blood
      glucose levels. Since beverages from calamansi are available and diabetes is a health concern
      in the community, it is important to investigate the effect of consuming this drink. Finger
      prick blood were tested in order to obtain the blood glucose levels for calculating the GI
      for the calamansi drink.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Change from baseline blood glucose levels
time frame: 30, 60, 90, 120 min after drinking
description: Capillary blood glucose using glucometer
measure: Change from baseline urinary glucose levels
time frame: 30, 60, 90, 120 min after drinking
description: Dipstick test
arm group label: Reference drink
arm group type: Active Comparator
description: Healthy volunteers' blood glucose response to reference drink (glucose)
arm group label: Test drink
arm group type: Experimental
description: Healthy volunteers' blood glucose response to test drink (calamansi)
intervention type: Other
intervention name: Calamansi
description: 250 ml of a commercially sourced calamansi drink
arm group label: Test drink
intervention type: Other
intervention name: Glucose
description: 75 g of glucose dissolved in 250 ml of drinking water
arm group label: Reference drink
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Angela Siner, PhD
role: Principal Investigator
affiliation: Universiti Malaysia Sarawak
facility: 
country: Malaysia
responsible party type: Sponsor
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: This will be made available starting 6 months from the date of publication; for the next 5 years.
ipd access criteria: Through reasonable request to the corresponding author.