<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/NCT02968498</url>
  </required_header>
  <id_info>
    <org_study_id>Lact-001-CEN</org_study_id>
    <nct_id>NCT02968498</nct_id>
  </id_info>
  <brief_title>Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers</brief_title>
  <official_title>Blood Glucose Response After Oral Intake of Lactulose in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Kabi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in&#xD;
      each study part.&#xD;
&#xD;
      The objective of the study is to investigate blood glucose levels after oral intake of&#xD;
      defined amounts of lactulose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))</measure>
    <time_frame>0-180 min</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum blood glucose concentration (Cmax)</measure>
    <time_frame>0-180 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum increase of blood glucose concentration (Max_increase)</measure>
    <time_frame>0-180 min</time_frame>
    <description>Cmax minus baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative maximum increase of blood glucose concentration(Max_increase rel)</measure>
    <time_frame>0-180 min</time_frame>
    <description>Cmax / baseline value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to reach maximum blood glucose concentration (Tmax)</measure>
    <time_frame>0-180 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)</measure>
    <time_frame>0-180 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))</measure>
    <time_frame>0-180 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))</measure>
    <time_frame>0-180 min</time_frame>
    <description>Area under curve from 0 to 180 min minus baseline*180min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>After screening till study day 22 (+24 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal tolerability (assessed by subject's questionnaire)</measure>
    <time_frame>180 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal tolerability (assessed by subject's questionnaire)</measure>
    <time_frame>24 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Blood Glucose</condition>
  <arm_group>
    <arm_group_label>Study arm 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactulose crystals 10 g</intervention_name>
    <description>White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.</description>
    <arm_group_label>Study arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactulose crystals 20 g</intervention_name>
    <description>White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.</description>
    <arm_group_label>Study arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactulose liquid 10 g</intervention_name>
    <description>Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.</description>
    <arm_group_label>Study arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactulose liquid 20 g</intervention_name>
    <description>Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.</description>
    <arm_group_label>Study arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Oral glucose 20 g</intervention_name>
    <description>White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.</description>
    <arm_group_label>Study arm 1</arm_group_label>
    <arm_group_label>Study arm 2</arm_group_label>
    <other_name>glucose monohydrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Still water</intervention_name>
    <description>Still water will be used. Water from the same source will be also used to dissolve investigational and control products.</description>
    <arm_group_label>Study arm 1</arm_group_label>
    <arm_group_label>Study arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers&#xD;
&#xD;
          -  Age: 18-65 years&#xD;
&#xD;
          -  Approx. 3-5 bowel movements per week&#xD;
&#xD;
          -  Caucasian&#xD;
&#xD;
          -  Availability and presence in the trial unit for approx. 4 hours/ week for 4 times in a&#xD;
             row with approx. 1 week of washout in between&#xD;
&#xD;
          -  Signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known (family) history of diabetes mellitus or use of anti-hyperglycaemic drugs or&#xD;
             Insulin&#xD;
&#xD;
          -  Clinically relevant renal or hepatic disease, liver enzymes &gt; 10% above reference&#xD;
             range&#xD;
&#xD;
          -  Fasting blood glucose &gt; 100 mg/dL or HbA1c outside of reference range&#xD;
&#xD;
          -  Total cholesterol &gt; 250 mg/dL or triglycerides &gt; 150 mg/dL&#xD;
&#xD;
          -  Haemoglobin &lt; 11 g/dL (women); &lt; 12.5 g/dL (men)&#xD;
&#xD;
          -  BMI &lt; 19 kg/m² and ≥ 30 kg/m²&#xD;
&#xD;
          -  Intentional and unintentional weight loss &gt; 5% in the previous 6 months&#xD;
&#xD;
          -  Smoker&#xD;
&#xD;
          -  Major medical or surgical event requiring hospitalization within the previous 3 months&#xD;
&#xD;
          -  Presence of disease or drug(s) influencing digestion and absorption of nutrients or&#xD;
             bowel habits&#xD;
&#xD;
          -  Intake of medications known to affect glucose tolerance, e.g., steroids, protease&#xD;
             inhibitors or antipsychotics (stable doses of e.g., oral contraceptives, thyroxin,&#xD;
             vitamins and mineral supplements or drugs to treat hypertension or osteoporosis are&#xD;
             acceptable)&#xD;
&#xD;
          -  Chronic intake of substances affecting blood coagulation (e.g. acetylic acid,&#xD;
             anticoagulants, diuretics, thiazides), which in the investigator's opinion would&#xD;
             impact volunteer safety&#xD;
&#xD;
          -  Hereditary problems of galactose or fructose intolerance, lactase deficiency or&#xD;
             glucose-galactose malabsorption&#xD;
&#xD;
          -  Suspicion of drug abuse&#xD;
&#xD;
          -  Abuse of alcoholic drinks, defined as an average daily intake of more than one litre&#xD;
             of beer per day or equivalent amount of alcohol in other beverages&#xD;
&#xD;
          -  Pregnant or breast feeding women&#xD;
&#xD;
          -  Known or suspected allergy to any component of the investigational product(s)&#xD;
&#xD;
          -  Known HIV-infection&#xD;
&#xD;
          -  Known acute or chronic hepatitis B and C infection&#xD;
&#xD;
          -  Blood donation within 4 weeks prior to visit 1 or during the study&#xD;
&#xD;
          -  Volunteer unable to co-operate adequately&#xD;
&#xD;
          -  Participation in a clinical trial with an investigational product within one month&#xD;
             before start of study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Menzel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CRO BioTeSys GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CRO BioTeSys GmbH</name>
      <address>
        <city>Esslingen</city>
        <zip>73728</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Blood glucose level</keyword>
  <keyword>Oral intake</keyword>
  <keyword>Lactulose</keyword>
  <keyword>Healthy volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
    <mesh_term>Lactulose</mesh_term>
  </intervention_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/NCT02968498
org study id: Lact-001-CEN
nct id: NCT02968498
lead sponsor: 
has dmc: No
Prospective, open, mono-center, randomized, two part study with 4-way cross-over design in
      each study part.

      The objective of the study is to investigate blood glucose levels after oral intake of
      defined amounts of lactulose.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Capillary blood glucose levels as incremental area under the curve (iAUC) above baseline (iAUC(0-180min))
time frame: 0-180 min
measure: Maximum blood glucose concentration (Cmax)
time frame: 0-180 min
measure: Maximum increase of blood glucose concentration (Max_increase)
time frame: 0-180 min
description: Cmax minus baseline value
measure: Relative maximum increase of blood glucose concentration(Max_increase rel)
time frame: 0-180 min
description: Cmax / baseline value
measure: Time to reach maximum blood glucose concentration (Tmax)
time frame: 0-180 min
measure: First time to reach baseline again after increase or decrease in blood glucose (Tbaseline)
time frame: 0-180 min
measure: Total area under curve from 0 to 180 min for blood glucose concentration (AUC(0-180min))
time frame: 0-180 min
measure: Baseline corrected area under curve from 0 to 180 min for blood glucose concentration (AUCbase_c(0-180min))
time frame: 0-180 min
description: Area under curve from 0 to 180 min minus baseline*180min
measure: Adverse events (AEs)
time frame: After screening till study day 22 (+24 hours)
measure: Gastrointestinal tolerability (assessed by subject's questionnaire)
time frame: 180 min
measure: Gastrointestinal tolerability (assessed by subject's questionnaire)
time frame: 24 hours post-dose
arm group label: Study arm 1
arm group type: Active Comparator
description: Lactulose crystals 10 g vs lactulose crystals 20 g vs oral glucose 20 g vs still water
arm group label: Study arm 2
arm group type: Active Comparator
description: Lactulose liquid 10 g vs lactulose liquid 20 g vs oral glucose 20 g vs still water
intervention type: Dietary Supplement
intervention name: Lactulose crystals 10 g
description: White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
arm group label: Study arm 1
intervention type: Dietary Supplement
intervention name: Lactulose crystals 20 g
description: White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
arm group label: Study arm 1
intervention type: Dietary Supplement
intervention name: Lactulose liquid 10 g
description: Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
arm group label: Study arm 2
intervention type: Dietary Supplement
intervention name: Lactulose liquid 20 g
description: Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
arm group label: Study arm 2
intervention type: Dietary Supplement
intervention name: Oral glucose 20 g
description: White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
arm group label: Study arm 1
arm group label: Study arm 2
other name: glucose monohydrate
intervention type: Dietary Supplement
intervention name: Still water
description: Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
arm group label: Study arm 1
arm group label: Study arm 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Menzel, MD
role: Principal Investigator
affiliation: CRO BioTeSys GmbH
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Methamphetamine
mesh term: Lactulose
sharing ipd: No