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/NCT05986253</url>
    </required_header>
    <id_info>
      <org_study_id>23_05_07_EHS</org_study_id>
      <nct_id>NCT05986253</nct_id>
    </id_info>
    <brief_title>BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes</brief_title>
    <official_title>BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Limerick</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Limerick</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>
        Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose&#xD;
        handling. The investigators have isolated and identified a bioactive protein extracted from&#xD;
        seaweed. The investigators aim to explore how varying doses of seaweed protein influence&#xD;
        postprandial glycaemia and insulinaemia in a population with type 2 diabetes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2031</completion_date>
    <primary_completion_date type="Anticipated">October 6, 2023</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 two arm, acute, randomised, double blind, placebo controlled, crossover design feeding study will be used to establish the impact of co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postprandial blood glucose area under the curve (AUC)</measure>
      <time_frame>120 minutes</time_frame>
      <description>Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Timecourse of blood glucose concentration</measure>
      <time_frame>0, 15, 30, 45, 60, 90, 120 minutes</time_frame>
      <description>Timecourse of blood glucose concentration (measured as mmol/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postprandial serum insulin area under the curve (AUC)</measure>
      <time_frame>120 minutes</time_frame>
      <description>Integrated area under curve of blood glucose concentration (measured as mU/L) over 120 minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postprandial serum insulin concentration</measure>
      <time_frame>0, 15, 30, 45, 60, 90, 120 minutes</time_frame>
      <description>Timecourse of serum insulin concentration (measured as mU/L)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>0.6g/kg body mass maltodextrin in solution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Protein</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Seaweed protein</intervention_name>
      <description>Novel protein extracted from seaweed</description>
      <arm_group_label>Protein</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Maltodextrin</intervention_name>
      <description>maltodextrin solution</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Protein</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Aged 18-67&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Terminal disease&#xD;
  &#xD;
            -  Exclusively receiving enteral or parenteral nutrition&#xD;
  &#xD;
            -  Any conditions/anomalies that are contraindications to bioelectrical impedance&#xD;
               analysis as per institutional risk assessment and standard operating procedures&#xD;
  &#xD;
            -  Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac&#xD;
               disease), thyroidal disease, cognitive impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>67 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brian Carson, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Limerick</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brian Carson, PhD</last_name>
      <phone>+353 061 234943</phone>
      <email>brian.carson@ul.ie</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Limerick</name>
        <address>
          <city>Limerick</city>
          <zip>V94 T9PX</zip>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brian Carson, PhD</last_name>
        <phone>+353 61 234943</phone>
      </contact>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No individual data will be shared with researchers outside of those named on the institutional ethics application form.</ipd_description>
    </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/NCT05986253
  org study id: 23_05_07_EHS
  nct id: NCT05986253
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose
        handling. The investigators have isolated and identified a bioactive protein extracted from
        seaweed. The investigators aim to explore how varying doses of seaweed protein influence
        postprandial glycaemia and insulinaemia in a population with type 2 diabetes.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: A two arm, acute, randomised, double blind, placebo controlled, crossover design feeding study will be used to establish the impact of co-ingestion of BioDulse (a protein hydrolysate from Irish seaweed) with maltodextrin on postprandial blood glucose and insulin concentrations.
  primary purpose: Basic Science
  masking: Single (Participant)
  measure: Postprandial blood glucose area under the curve (AUC)
  time frame: 120 minutes
  description: Integrated area under curve of blood glucose concentration (measured as mmol/L) over 120 minutes
  measure: Timecourse of blood glucose concentration
  time frame: 0, 15, 30, 45, 60, 90, 120 minutes
  description: Timecourse of blood glucose concentration (measured as mmol/L)
  measure: Postprandial serum insulin area under the curve (AUC)
  time frame: 120 minutes
  description: Integrated area under curve of blood glucose concentration (measured as mU/L) over 120 minutes
  measure: Postprandial serum insulin concentration
  time frame: 0, 15, 30, 45, 60, 90, 120 minutes
  description: Timecourse of serum insulin concentration (measured as mU/L)
  arm group label: Control
  arm group type: Placebo Comparator
  description: 0.6g/kg body mass maltodextrin in solution
  arm group label: Protein
  arm group type: Experimental
  description: 0.6g/kg body mass maltodextrin PLUS 0.15g/kg body mass protein from Biodulse, in solution
  intervention type: Dietary Supplement
  intervention name: Seaweed protein
  description: Novel protein extracted from seaweed
  arm group label: Protein
  intervention type: Dietary Supplement
  intervention name: Maltodextrin
  description: maltodextrin solution
  arm group label: Control
  arm group label: Protein
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 67 Years
  healthy volunteers: No
  last name: Brian Carson, PhD
  role: Principal Investigator
  affiliation: University of Limerick
  last name: Brian Carson, PhD
  phone: +353 061 234943
  email: brian.carson@ul.ie
  facility: 
  status: Recruiting
  contact: 
  country: Ireland
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No
  ipd description: No individual data will be shared with researchers outside of those named on the institutional ethics application form.