<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/NCT03002168</url>
  </required_header>
  <id_info>
    <org_study_id>16-005006</org_study_id>
    <nct_id>NCT03002168</nct_id>
  </id_info>
  <brief_title>Determining Lipid Content in Stool After Alpha-cyclodextrin</brief_title>
  <acronym>FMAT</acronym>
  <official_title>A Single Center, Randomized, Double-blind, Placebo Controlled, Two-way Crossover Study to Determine the Fat Losses in Stool Associated With Alpha-CD Use as Compared to Placebo Using a Radiotracer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SFI Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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 Investigator hypothesizes that the currently used dose of dietary ingredient&#xD;
      alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared&#xD;
      with placebo. The proposed studies will address the degree to which α-CD increases dietary&#xD;
      fat loss.&#xD;
&#xD;
      The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester,&#xD;
      Minnesota.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single-center, randomized, double-blind, placebo controlled, two-way crossover&#xD;
      trial in healthy volunteers. The primary objective is to determine the fat losses in stool&#xD;
      associated with alpha-cyclodextrin use as compared to placebo using a radiotracer. The study&#xD;
      design will include two treatment periods, assigned in random order:&#xD;
&#xD;
        -  Treatment 1 consists of subjects receiving α-CD and a meal containing the fatty acid&#xD;
           radiotracers&#xD;
&#xD;
        -  Treatment 2 consists of subjects receiving placebo and a meal containing the fatty acid&#xD;
           radiotracers&#xD;
&#xD;
      All subjects randomized to receive α-CD will orally ingest two tablets containing α-CD, or&#xD;
      placebo, with a standardized liquid breakfast (100 µ Ci of [3H]triolein and 20 µ Ci of [14C]&#xD;
      tripalmitin). The tablets will be consumed with 150 ml of still (uncarbonated) water&#xD;
      immediately prior to consuming each meal.&#xD;
&#xD;
      Subjects will be observed for a period of 48 hours as an in-patient, and then an additional&#xD;
      24 hours as an out-patient following the breakfast meal containing the radiotracers. During&#xD;
      this time the participants will undergo a meal fatty acid metabolism study, through hourly&#xD;
      blood and fecal sampling, to assess meal fatty acid oxidation and storage.&#xD;
&#xD;
      The participants will then undergo a further ≥ 14 day washout period before crossing over to&#xD;
      the alternate treatment, where all evaluations will be repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">June 5, 2017</completion_date>
  <primary_completion_date type="Actual">June 5, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in lipid content in stool, measured using 3^H radiolabeled tracer</measure>
    <time_frame>Baseline, 6 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lipid content in stool, measured using 14^C radiolabeled tracer</measure>
    <time_frame>Baseline, 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood triglyceride concentrations, measured using 3^H radiolabeled tracer</measure>
    <time_frame>Baseline, 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood triglyceride concentrations, measured using 14^C radiolabeled tracer</measure>
    <time_frame>Baseline, 6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood glucose concentration</measure>
    <time_frame>Baseline, 6 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Alpha-cyclodextrin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two 1 gram Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets (6 grams) per day for the first two consecutive days of active treatment period. Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two Placebo Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets per day for the first two consecutive days of placebo treatment period.Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Alpha-cyclodextrin</intervention_name>
    <description>Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.</description>
    <arm_group_label>Alpha-cyclodextrin</arm_group_label>
    <other_name>FBCx</other_name>
    <other_name>Calorease</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablets identical in appearance to the active comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Triolein radiolabeled with 100 microcuries of 3^Hydrogen</intervention_name>
    <description>A MicroCurie (µCi) is a measure of radioactivity.</description>
    <arm_group_label>Alpha-cyclodextrin</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Tripalmitin radiolabeled with 20 microcuries of 14^Carbon</intervention_name>
    <description>A MicroCurie (µCi) is a measure of radioactivity.</description>
    <arm_group_label>Alpha-cyclodextrin</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy weight stable individuals (defined as a Body Mass Index (BMI) of ≥18.5 and&#xD;
             &lt;27, and stable for at least the preceding two months from Screening).&#xD;
&#xD;
          -  Not pregnant, and if of childbearing potential, agrees to use adequate birth control&#xD;
             (hormonal or barrier method of birth control or abstinence) prior to study entry and&#xD;
             during the trial and agrees not to donate sperm or ova, for the duration of the study&#xD;
&#xD;
          -  Subjects ≥18 and ≤60 years of age at screening&#xD;
&#xD;
          -  Consistent regular bowel movement (defined as between 3 times a day, to 1 time per&#xD;
             day)&#xD;
&#xD;
          -  Provide Informed Consent&#xD;
&#xD;
          -  Willing and able to complete study procedures within the study timelines&#xD;
&#xD;
          -  Adequate renal function: serum creatinine less than 1.5 x Upper Limit of Normal (ULN)&#xD;
&#xD;
          -  Adequate liver function: serum glutamic oxaloacetic transaminase/aspartate&#xD;
             aminotransferase (SGOT/AST) and serum glutamic pyruvic transaminase/alanine&#xD;
             aminotransferase (SGPT/ALT) ≤ 2 × ULN and serum bilirubin ≤ 1.5 × ULN, unless&#xD;
             Gilbert's syndrome has previously been confirmed for the subject&#xD;
&#xD;
          -  Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm^3, absolute&#xD;
             neutrophil count (ANC) ≥ 1,500/mm^3, hemoglobin ≥ 9 gram/deciLiter, and platelets ≥&#xD;
             100,000/mm^3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of chronic pancreatitis&#xD;
&#xD;
          -  Evidence of irritable bowel syndrome (medical or self-diagnosed)&#xD;
&#xD;
          -  Previous gallbladder surgery&#xD;
&#xD;
          -  Use of enemas and/or suppositories within 30 days of Screening&#xD;
&#xD;
          -  Consuming ≥ 375 mg of caffeine per day (equivalent to 5 serves of 1 oz. restaurant&#xD;
             style espresso per day)&#xD;
&#xD;
          -  History of febrile illness within 5 days prior to Screening&#xD;
&#xD;
          -  Evidence or history of substance or alcohol abuse&#xD;
&#xD;
          -  History of major depression, bipolar disorder, or schizophrenia (per DSM4 criteria;&#xD;
             Diagnostic and Statistical Manual of Mental Disorders)&#xD;
&#xD;
          -  Current use of prescription or non-prescription weight loss products (≥ 2 week washout&#xD;
             period is required to become eligible)&#xD;
&#xD;
          -  Smoking ≥ 20 cigarettes (~one pack) per week&#xD;
&#xD;
          -  Significant dietary restrictions (incl. vegan, vegetarian diets and any subject not&#xD;
             prepared to consume any of the standardized food/s)&#xD;
&#xD;
          -  Evidence of an active eating disorder (incl. anorexia nervosa, bulimia, and/or&#xD;
             obsessive compulsive disorders)&#xD;
&#xD;
          -  Use of other investigational agent(s at the time of enrollment, or within 30 days or&#xD;
             five half-lives of enrollment, whichever is longer&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Current use of any medication known to affect gut motility&#xD;
&#xD;
          -  History of malignancy, treated or untreated, within the past five years, with the&#xD;
             exception of non-melanoma skin cancer and cervical carcinoma in situ&#xD;
&#xD;
          -  A known history of hypersensitivity to any of the α-CD ingredients&#xD;
&#xD;
          -  Any other health condition that would preclude participation in the study in the&#xD;
             judgment of the principal investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael D Jensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>November 15, 2017</last_update_submitted>
  <last_update_submitted_qc>November 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Michael D. Jensen</investigator_full_name>
    <investigator_title>MD, Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03002168
org study id: 16-005006
nct id: NCT03002168
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Investigator hypothesizes that the currently used dose of dietary ingredient
      alpha-cyclodextrin (α-CD) will result in greater loss of dietary fat in the stool compared
      with placebo. The proposed studies will address the degree to which α-CD increases dietary
      fat loss.

      The Investigator will conduct the study and analyze the samples at Mayo Clinic in Rochester,
      Minnesota.
This is a single-center, randomized, double-blind, placebo controlled, two-way crossover
      trial in healthy volunteers. The primary objective is to determine the fat losses in stool
      associated with alpha-cyclodextrin use as compared to placebo using a radiotracer. The study
      design will include two treatment periods, assigned in random order:

        -  Treatment 1 consists of subjects receiving α-CD and a meal containing the fatty acid
           radiotracers

        -  Treatment 2 consists of subjects receiving placebo and a meal containing the fatty acid
           radiotracers

      All subjects randomized to receive α-CD will orally ingest two tablets containing α-CD, or
      placebo, with a standardized liquid breakfast (100 µ Ci of [3H]triolein and 20 µ Ci of [14C]
      tripalmitin). The tablets will be consumed with 150 ml of still (uncarbonated) water
      immediately prior to consuming each meal.

      Subjects will be observed for a period of 48 hours as an in-patient, and then an additional
      24 hours as an out-patient following the breakfast meal containing the radiotracers. During
      this time the participants will undergo a meal fatty acid metabolism study, through hourly
      blood and fecal sampling, to assess meal fatty acid oxidation and storage.

      The participants will then undergo a further ≥ 14 day washout period before crossing over to
      the alternate treatment, where all evaluations will be repeated.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Change in lipid content in stool, measured using 3^H radiolabeled tracer
time frame: Baseline, 6 hours
measure: Change in lipid content in stool, measured using 14^C radiolabeled tracer
time frame: Baseline, 6 hours
measure: Change in blood triglyceride concentrations, measured using 3^H radiolabeled tracer
time frame: Baseline, 6 hours
measure: Change in blood triglyceride concentrations, measured using 14^C radiolabeled tracer
time frame: Baseline, 6 hours
measure: Change in blood glucose concentration
time frame: Baseline, 6 hours
arm group label: Alpha-cyclodextrin
arm group type: Active Comparator
description: Two 1 gram Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets (6 grams) per day for the first two consecutive days of active treatment period. Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal.
arm group label: Placebo
arm group type: Placebo Comparator
description: Two Placebo Alpha-cyclodextrin tablets given per fat-containing meal. A total of 6 tablets per day for the first two consecutive days of placebo treatment period.Triolein radiolabeled with 100 microcuries of 3^Hydrogen and Tripalmitin radiolabeled with 20 microcuries of 14^Carbon given orally with liquid breakfast meal.
intervention type: Dietary Supplement
intervention name: Alpha-cyclodextrin
description: Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.
arm group label: Alpha-cyclodextrin
other name: FBCx
other name: Calorease
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo tablets identical in appearance to the active comparator
arm group label: Placebo
intervention type: Radiation
intervention name: Triolein radiolabeled with 100 microcuries of 3^Hydrogen
description: A MicroCurie (µCi) is a measure of radioactivity.
arm group label: Alpha-cyclodextrin
arm group label: Placebo
intervention type: Radiation
intervention name: Tripalmitin radiolabeled with 20 microcuries of 14^Carbon
description: A MicroCurie (µCi) is a measure of radioactivity.
arm group label: Alpha-cyclodextrin
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael D Jensen, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Michael D. Jensen
investigator title: MD, Principal Investigator
sharing ipd: Yes