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/NCT05963594</url>
    </required_header>
    <id_info>
      <org_study_id>22.06.CLI</org_study_id>
      <nct_id>NCT05963594</nct_id>
    </id_info>
    <brief_title>To Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With T2D and in HAO</brief_title>
    <acronym>LORIS-02</acronym>
    <official_title>A Randomized, Double-Blind, Comparator-Controlled, Crossover Study to Evaluate the Post-Prandial Metabolic Effects of Oligomalt in Adults With Type 2 Diabetes (T2D) and in Otherwise Healthy Adults With Overweight or Obesity (HAO)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Société des Produits Nestlé (SPN)</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Société des Produits Nestlé (SPN)</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 goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt&#xD;
        to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy&#xD;
        adults with overweight or obesity (HAO).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main question it aims to answer is how consumption of Oligomalt, a slowly digestible&#xD;
        carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative&#xD;
        to Glucidex 40.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 23, 2023</start_date>
    <completion_date type="Actual">March 28, 2023</completion_date>
    <primary_completion_date type="Actual">March 28, 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>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
      <description>Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total blood glucose AUC</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood glucose (iCmax)</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
      <description>Maximum blood glucose level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood glucose (Cmin)</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
      <description>Minimum blood glucose level</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood glucose (Tmax)</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
      <description>Time point at which maximum blood glucose level is measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood glucose (Tmin)</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
      <description>Time point at which minimum blood glucose level is measured</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with glucose levels less than or equal to 3.9 mmol/L</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with glucose levels less than or equal to 3.1 mmol/L</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Serum insulin level</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulinogenic index (IGI)</measure>
      <time_frame>30 minutes</time_frame>
      <description>A measure of early β-cell capacity (first- phase insulin response)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin index</measure>
      <time_frame>Over the course of 2 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Matsuda Index (MI)</measure>
      <time_frame>Over the course of 2 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma glucagon-like peptide 1 (GLP-1)</measure>
      <time_frame>Over the course of up to 3 hours following study product intake</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma peptide tyrosine (PYY)</measure>
      <time_frame>Over the course of up to 3 hours following study product intake</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>Plasma glucose at individual timepoints</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Between-group comparison of changes in glucose slope</measure>
      <time_frame>From the time point at which maximum glucose level is measured to 3 hours</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Between group comparison of mean &quot;Interquartile range&quot;</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
      <description>IQR is defined as the difference between mean Q1 and mean Q3 glucose levels (mmol/L)</description>
    </other_outcome>
    <other_outcome>
      <measure>Serum insulin at individual timepoints</measure>
      <time_frame>Over the course of 3 hours following study product intake</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Plasma glucagon-like peptide 1 (GLP-1) at individual timepoints</measure>
      <time_frame>Over the course of 2 hours following study product intake</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Plasma peptide tyrosine (PYY) at individual timepoints</measure>
      <time_frame>Over the course of 2 hours following study product intake</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Plasma glucagon-like peptide 1 (GLP-1)</measure>
      <time_frame>Over the course of 1 hour following study product intake</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Plasma peptide tyrosine (PYY)</measure>
      <time_frame>Over the course of 1 hour following study product intake</time_frame>
    </other_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Actual">44</enrollment>
    <condition>Dietary Supplement</condition>
    <arm_group>
      <arm_group_label>T2D Sequence AB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Where A = 50 g Oligomalt and B = 50 g Glucidex 40.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>T2D Sequence BA</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Where A = 50 g Oligomalt and B = 50 g Glucidex 40.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HAO Sequence ABCD</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HAO Sequence BDAC</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HAO Sequence DCBA</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HAO Sequence CADB</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Oligomalt</intervention_name>
      <description>The investigational product (Oligomalt) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.</description>
      <arm_group_label>HAO Sequence ABCD</arm_group_label>
      <arm_group_label>HAO Sequence BDAC</arm_group_label>
      <arm_group_label>HAO Sequence CADB</arm_group_label>
      <arm_group_label>HAO Sequence DCBA</arm_group_label>
      <arm_group_label>T2D Sequence AB</arm_group_label>
      <arm_group_label>T2D Sequence BA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>maltodextrin</intervention_name>
      <description>The investigational product (maltodextrin) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.</description>
      <arm_group_label>HAO Sequence ABCD</arm_group_label>
      <arm_group_label>HAO Sequence BDAC</arm_group_label>
      <arm_group_label>HAO Sequence CADB</arm_group_label>
      <arm_group_label>HAO Sequence DCBA</arm_group_label>
      <arm_group_label>T2D Sequence AB</arm_group_label>
      <arm_group_label>T2D Sequence BA</arm_group_label>
      <other_name>Glucidex 40</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Type 2 Diabetes (T2D)&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Willing and able to sign written informed consent prior to study entry.&#xD;
  &#xD;
            2. Male or female, &gt;18 years of age.&#xD;
  &#xD;
            3. Established diagnosis of T2D (documented by either HbA1c 6.5 - 10.0% or a history of&#xD;
               T2D diagnosis).&#xD;
  &#xD;
            4. Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000 mg at&#xD;
               screening. Dose of metformin must have been stable for at least 3 months prior to&#xD;
               screening.&#xD;
  &#xD;
            5. Participants must have a hematocrit value greater than or equal to 34.0% for females&#xD;
               and 40% for males.&#xD;
  &#xD;
            6. Participants must have a hemoglobin value greater than or equal to 11.0 g/dL for&#xD;
               females and 13.5 g/dL for males.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Type 1 diabetes.&#xD;
  &#xD;
            2. Known food allergy or intolerance to study products.&#xD;
  &#xD;
            3. Major medical/surgical event in the last 3 months potentially interfering with study&#xD;
               procedures and assessments.&#xD;
  &#xD;
            4. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory&#xD;
               bowel disease, diverticular diseases, colon cancer), or history of chronic&#xD;
               constipation with passage of fewer than 3 spontaneous bowel movements per week on&#xD;
               average or chronic or recurrent diarrhea with spontaneous bowel movements more often&#xD;
               than 3 times daily.&#xD;
  &#xD;
            5. Any concomitant medication potentially interfering with study procedures and&#xD;
               assessment: such as antibiotics, antiacids, or other medications impacting transit&#xD;
               time, colonoscopy, irrigoscopy or other bowel cleansing procedures 4 weeks prior to&#xD;
               dosing.&#xD;
  &#xD;
            6. Current use of injectable insulin therapy, any other oral (other than metformin) or&#xD;
               injectable glucose-lowering drug. Current use of weight loss interventions or&#xD;
               treatment with anorectic drugs (e.g., GLP-1 receptor analogues).&#xD;
  &#xD;
            7. Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs,&#xD;
               heparin, platelet inhibitors).&#xD;
  &#xD;
            8. Current treatment with systemic steroids (application of inhaled or topical steroids&#xD;
               is permitted).&#xD;
  &#xD;
            9. Recent episode of an acute gastrointestinal illness.&#xD;
  &#xD;
           10. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of&#xD;
               strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.&#xD;
  &#xD;
           11. Current daily cigarette smoking.&#xD;
  &#xD;
           12. Are unable to comply with protocol procedures in the opinion of the investigator.&#xD;
  &#xD;
           13. Have a hierarchical link with the research team members.&#xD;
  &#xD;
           14. Positive pregnancy test or breast-feeding at screening.&#xD;
  &#xD;
           15. Participants who have been dosed in another clinical study with any investigational&#xD;
               drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to&#xD;
               screening.&#xD;
  &#xD;
           16. Donation of blood or significant amount of blood loss within 8 weeks prior to&#xD;
               screening. Participants must also agree to not donate blood within 8 weeks after their&#xD;
               last visit.&#xD;
  &#xD;
          HAO:&#xD;
  &#xD;
          Otherwise Healthy Adults (HAO) with overweight or obese but who DO NOT present with a&#xD;
          confirmed diagnosis of diabetes mellitus&#xD;
  &#xD;
          Inclusion criteria:&#xD;
  &#xD;
            1. Willing and able to sign written informed consent prior to study entry.&#xD;
  &#xD;
            2. Male or female, &gt;18 years of age.&#xD;
  &#xD;
            3. BMI ≥ 25 kg/m2.&#xD;
  &#xD;
            4. Fasting plasma glucose (FPG) ≤ 125 mg/dL.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            1. Type 1 or type 2 diabetes (including those potentially detected at screening).&#xD;
  &#xD;
            2. 2-h plasma glucose ≥ 200 mg/dL - if measured within 6 weeks prior to screening.&#xD;
  &#xD;
            3. Known food allergy or intolerance to study products.&#xD;
  &#xD;
            4. Major medical/surgical event in the last 3 months potentially interfering with study&#xD;
               procedures and assessments.&#xD;
  &#xD;
            5. Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory&#xD;
               bowel disease, diverticular diseases, colon cancer), or history of chronic&#xD;
               constipation with passage of fewer than 3 spontaneous bowel movements per week on&#xD;
               average or chronic or recurrent diarrhea with spontaneous bowel movements more often&#xD;
               than 3 times daily.&#xD;
  &#xD;
            6. Any concomitant medication potentially interfering with study procedures and&#xD;
               assessment: such as antibiotics, antiacids, or other medications impacting transit&#xD;
               time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior to&#xD;
               dosing.&#xD;
  &#xD;
            7. Current use of injectable insulin therapy, any oral or injectable glucose-lowering&#xD;
               drug.&#xD;
  &#xD;
            8. Current use of weight loss interventions or treatment with anorectic drugs (e.g.,&#xD;
               GLP-1 receptor analogues).&#xD;
  &#xD;
            9. Current treatment with anticoagulants or antithrombotic agents (warfarin, NOACs,&#xD;
               heparin, platelet inhibitors).&#xD;
  &#xD;
           10. Current treatment with systemic steroids (application of inhaled or topical steroids&#xD;
               is permitted).&#xD;
  &#xD;
           11. Recent episode of an acute gastrointestinal illness.&#xD;
  &#xD;
           12. Alcohol intake higher than 2 servings per day. A serving is 0.4 dl/1.41 ounces of&#xD;
               strong alcohols, 1 dl/3.5 ounces of red or white wine, or 3 dl/10.6 ounces of beer.&#xD;
  &#xD;
           13. Current daily cigarette smoking.&#xD;
  &#xD;
           14. Are unable to comply with protocol procedures in the opinion of the investigator.&#xD;
  &#xD;
           15. Positive pregnancy test or breast-feeding at screening.&#xD;
  &#xD;
           16. Participants who have been dosed in another clinical study with any investigational&#xD;
               drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to&#xD;
               screening.&#xD;
  &#xD;
           17. Donation of blood or significant amount of blood loss within 8 weeks prior to&#xD;
               screening. Participants must also agree to not donate blood within 8 weeks after their&#xD;
               last visit.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joel Neutel, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Orange County Research Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Orange County Research Center</name>
        <address>
          <city>Tustin</city>
          <state>California</state>
          <zip>92780</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</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>
  
  
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/NCT05963594
  org study id: 22.06.CLI
  nct id: NCT05963594
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this mechanistic, exploratory study is to compare the effectiveness of Oligomalt
        to Glucidex 40 after eating in adults with Type 2 Diabetes (T2D) and in otherwise healthy
        adults with overweight or obesity (HAO).
  The main question it aims to answer is how consumption of Oligomalt, a slowly digestible
        carbohydrate, will reduce glucose and insulin spikes in adults with T2D and in HAO relative
        to Glucidex 40.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: Incremental area under the curve (iAUC) of post-prandial glycemic excursion induced by Oligomalt relative to maltodextrin over the observation period: iAUC 0-1 hour, iAUC 0-2 hours, iAUC 0-3 hours.
  time frame: Over the course of 3 hours following study product intake
  description: Comparisons in the T2D group: 50 g Oligomalt vs 50 g Glucidex 40. Comparisons in the HAO group: 33 g Oligomalt vs 33 g Glucidex 40 and 50 g Oligomalt vs 50 g Glucidex 40.
  measure: Total blood glucose AUC
  time frame: Over the course of 3 hours following study product intake
  measure: Blood glucose (iCmax)
  time frame: Over the course of 3 hours following study product intake
  description: Maximum blood glucose level
  measure: Blood glucose (Cmin)
  time frame: Over the course of 3 hours following study product intake
  description: Minimum blood glucose level
  measure: Blood glucose (Tmax)
  time frame: Over the course of 3 hours following study product intake
  description: Time point at which maximum blood glucose level is measured
  measure: Blood glucose (Tmin)
  time frame: Over the course of 3 hours following study product intake
  description: Time point at which minimum blood glucose level is measured
  measure: Number of participants with glucose levels less than or equal to 3.9 mmol/L
  time frame: Over the course of 3 hours following study product intake
  measure: Number of participants with glucose levels less than or equal to 3.1 mmol/L
  time frame: Over the course of 3 hours following study product intake
  measure: Serum insulin level
  time frame: Over the course of 3 hours following study product intake
  measure: Insulinogenic index (IGI)
  time frame: 30 minutes
  description: A measure of early β-cell capacity (first- phase insulin response)
  measure: Insulin index
  time frame: Over the course of 2 hours following study product intake
  measure: Matsuda Index (MI)
  time frame: Over the course of 2 hours following study product intake
  measure: Plasma glucagon-like peptide 1 (GLP-1)
  time frame: Over the course of up to 3 hours following study product intake
  measure: Plasma peptide tyrosine (PYY)
  time frame: Over the course of up to 3 hours following study product intake
  measure: Plasma glucose at individual timepoints
  time frame: Over the course of 3 hours following study product intake
  measure: Between-group comparison of changes in glucose slope
  time frame: From the time point at which maximum glucose level is measured to 3 hours
  measure: Between group comparison of mean "Interquartile range"
  time frame: Over the course of 3 hours following study product intake
  description: IQR is defined as the difference between mean Q1 and mean Q3 glucose levels (mmol/L)
  measure: Serum insulin at individual timepoints
  time frame: Over the course of 3 hours following study product intake
  measure: Plasma glucagon-like peptide 1 (GLP-1) at individual timepoints
  time frame: Over the course of 2 hours following study product intake
  measure: Plasma peptide tyrosine (PYY) at individual timepoints
  time frame: Over the course of 2 hours following study product intake
  measure: Plasma glucagon-like peptide 1 (GLP-1)
  time frame: Over the course of 1 hour following study product intake
  measure: Plasma peptide tyrosine (PYY)
  time frame: Over the course of 1 hour following study product intake
  arm group label: T2D Sequence AB
  arm group type: Active Comparator
  description: Where A = 50 g Oligomalt and B = 50 g Glucidex 40.
  arm group label: T2D Sequence BA
  arm group type: Active Comparator
  description: Where A = 50 g Oligomalt and B = 50 g Glucidex 40.
  arm group label: HAO Sequence ABCD
  arm group type: Active Comparator
  description: Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
  arm group label: HAO Sequence BDAC
  arm group type: Active Comparator
  description: Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
  arm group label: HAO Sequence DCBA
  arm group type: Active Comparator
  description: Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
  arm group label: HAO Sequence CADB
  arm group type: Active Comparator
  description: Where A = 50 g Oligomalt, B = 50 g Glucidex 40, C = 33 g Oligomalt, and D = 33 g maltodextrin Glucidex 40.
  intervention type: Dietary Supplement
  intervention name: Oligomalt
  description: The investigational product (Oligomalt) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.
  arm group label: HAO Sequence ABCD
  arm group label: HAO Sequence BDAC
  arm group label: HAO Sequence CADB
  arm group label: HAO Sequence DCBA
  arm group label: T2D Sequence AB
  arm group label: T2D Sequence BA
  intervention type: Dietary Supplement
  intervention name: maltodextrin
  description: The investigational product (maltodextrin) dissolved in 300 ml water will be consumed over approximately 10 minutes in the morning of the study visit after a fasting period of at least 10 hours.
  arm group label: HAO Sequence ABCD
  arm group label: HAO Sequence BDAC
  arm group label: HAO Sequence CADB
  arm group label: HAO Sequence DCBA
  arm group label: T2D Sequence AB
  arm group label: T2D Sequence BA
  other name: Glucidex 40
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Joel Neutel, MD
  role: Principal Investigator
  affiliation: Orange County Research Center
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No