<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/NCT03763240</url>
  </required_header>
  <id_info>
    <org_study_id>BSE</org_study_id>
    <nct_id>NCT03763240</nct_id>
  </id_info>
  <brief_title>BSE on Blood Glucose</brief_title>
  <official_title>Effect of BSE on Blood Glucose</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Göteborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Skane</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>
      Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract&#xD;
      (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will&#xD;
      address whether BSE could be used to improve glucose control in drug-naïve pre-diabetic&#xD;
      individuals. The participants will receive BSE or placebo in a randomized double-blind&#xD;
      parallel arm study. The participants will take their study compound once daily over 12 weeks.&#xD;
      The primary study variable is fasting glucose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract&#xD;
      (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will&#xD;
      address whether BSE could be used to improve glucose control in drug-naïve pre-diabetic&#xD;
      individuals. The participants will receive BSE or placebo in a randomized double-blind&#xD;
      parallel arm study. The participants will take their study compound once daily over 12 weeks.&#xD;
      The primary study variable is fasting glucose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Parallel arm study with placebo and intervention substance</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Each participant receives the kit that corresponds to his/her study ID. The randomization is blind to both participants and the Investigator during the study.&#xD;
The randomization list is kept with the local pharmacy during the entire study. Sealed envelopes with randomization information for each participant are send to investigator and may be opened in case of emergency.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The primary effect variable is venous fasting blood glucose.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Participants will be analysed using intraindividual one-tailed comparisons before and after treatment and compared between the placebo and BSE arms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Blood Glucose, High</condition>
  <arm_group>
    <arm_group_label>BSE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sulforaphane-containing broccoli sprout extract (BSE). The study product is BSE with standardized amounts of sulforaphane. BSE contains a mixture of maltodextrin as a bulking agent and copper chlorophyllin (E 141) as a food additive. BSE is a dried powder of an aqueous extract of broccoli sprouts that provides a consistent and stable source of sulforaphane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A mixture of maltodextrin and copper chlorophyllin will be used as placebo. The active compound and the placebo are the same except BSE. The placebo will look similar to the BSE-containing mixture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BSE</intervention_name>
    <description>BSE powder will be provided as dry mixtures in sealed, non-transparent portion size bags. Each BSE bag contains 150 μmole, equal to 0.26 g, sulforaphane at a minimum. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning. BSE should be stored at room temperature in dry conditions.&#xD;
The doses of sulforaphane contained in the BSE is not possible to get by eating fresh broccoli, thus it has to be given as an extract.</description>
    <arm_group_label>BSE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo powder will be provided as dry mixtures in sealed, non-transparent portion size bags. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Impaired fasting glucose, defined as fasting blood glucose 6.1-6.9 mM.&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Age 35-75 years. Participating women of fertile age must have no current pregnancy,&#xD;
             which will be assessed by pregnancy test.&#xD;
&#xD;
          -  Body mass index 27-45 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with diabetes mellitus according to the WHO criteria&#xD;
&#xD;
          -  Anti-diabetic medication&#xD;
&#xD;
          -  Active liver disease&#xD;
&#xD;
          -  At screening or at any subsequent visit a level of aspartate aminotransferase (ASAT)&#xD;
             or alanine aminotransferase (ALAT) of more than three times the upper limit of the&#xD;
             normal range&#xD;
&#xD;
          -  Gastrointestinal ailments which may interfere with the ability to adequately absorb&#xD;
             sulforaphane&#xD;
&#xD;
          -  At screening visit creatinine &gt; 130 µmol/L&#xD;
&#xD;
          -  Coagulation disorder or current anti-coagulant therapy, which may be affected by the&#xD;
             BSE&#xD;
&#xD;
          -  Diagnosed with a cardiovascular disease or known cardiovascular event, transient&#xD;
             ischemic attack, coronary by-pass surgery or other coronary vessel intervention within&#xD;
             6 months prior to enrolment&#xD;
&#xD;
          -  Systemic glucocorticoid treatment&#xD;
&#xD;
          -  Herbal treatment, defined as food supplement (except multivitamin treatment) with&#xD;
             herbal or vegetable extracts that may affect blood glucose&#xD;
&#xD;
          -  Allergy to broccoli&#xD;
&#xD;
          -  Participant unable to understand the study information&#xD;
&#xD;
          -  Participation in other clinical trial which may affect the outcome of the present&#xD;
             study&#xD;
&#xD;
          -  Any other physical or psychiatric condition or treatment that in the judgment of the&#xD;
             investigator makes it difficult to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Gothia Forum</name>
      <address>
        <city>Gothenburg</city>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>January 16, 2022</last_update_submitted>
  <last_update_submitted_qc>January 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03763240
org study id: BSE
nct id: NCT03763240
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract
      (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will
      address whether BSE could be used to improve glucose control in drug-naïve pre-diabetic
      individuals. The participants will receive BSE or placebo in a randomized double-blind
      parallel arm study. The participants will take their study compound once daily over 12 weeks.
      The primary study variable is fasting glucose.
Here we will investigate the effect of sulforaphane, provided as a broccoli sprout extract
      (BSE) on blood glucose in pre-diabetic individuals without metformin treatment. This will
      address whether BSE could be used to improve glucose control in drug-naïve pre-diabetic
      individuals. The participants will receive BSE or placebo in a randomized double-blind
      parallel arm study. The participants will take their study compound once daily over 12 weeks.
      The primary study variable is fasting glucose.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel arm study with placebo and intervention substance
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Each participant receives the kit that corresponds to his/her study ID. The randomization is blind to both participants and the Investigator during the study.
The randomization list is kept with the local pharmacy during the entire study. Sealed envelopes with randomization information for each participant are send to investigator and may be opened in case of emergency.
measure: The primary effect variable is venous fasting blood glucose.
time frame: 12 weeks
description: Participants will be analysed using intraindividual one-tailed comparisons before and after treatment and compared between the placebo and BSE arms
arm group label: BSE
arm group type: Active Comparator
description: Sulforaphane-containing broccoli sprout extract (BSE). The study product is BSE with standardized amounts of sulforaphane. BSE contains a mixture of maltodextrin as a bulking agent and copper chlorophyllin (E 141) as a food additive. BSE is a dried powder of an aqueous extract of broccoli sprouts that provides a consistent and stable source of sulforaphane.
arm group label: Placebo
arm group type: Placebo Comparator
description: A mixture of maltodextrin and copper chlorophyllin will be used as placebo. The active compound and the placebo are the same except BSE. The placebo will look similar to the BSE-containing mixture.
intervention type: Dietary Supplement
intervention name: BSE
description: BSE powder will be provided as dry mixtures in sealed, non-transparent portion size bags. Each BSE bag contains 150 μmole, equal to 0.26 g, sulforaphane at a minimum. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning. BSE should be stored at room temperature in dry conditions.
The doses of sulforaphane contained in the BSE is not possible to get by eating fresh broccoli, thus it has to be given as an extract.
arm group label: BSE
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo powder will be provided as dry mixtures in sealed, non-transparent portion size bags. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning.
arm group label: Placebo
criteria: 
gender: All
minimum age: 35 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Sweden
responsible party type: Sponsor
sharing ipd: No