<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/NCT02999620</url>
  </required_header>
  <id_info>
    <org_study_id>SFIR-FMAT-US01</org_study_id>
    <nct_id>NCT02999620</nct_id>
  </id_info>
  <brief_title>FBCx (Alpha-CD) Mechanism of Action Trial</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>SFI Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SFI Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as&#xD;
      compared to placebo when consumed with a standardized radiolabeled fatty meal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical investigation will determine the fat losses in stool associated with alpha-CD&#xD;
      use as compared to placebo when ingested with a standardized liquid breakfast (100 microCi of&#xD;
      [3H]triolein) and 20 microCi of [14C]tripalmitin). The ingested dose will be 2 g of α-CD at&#xD;
      each of three meals per day for 2 days.&#xD;
&#xD;
      Eight subjects will be recruited in a two-way crossover design consisting of two treatment&#xD;
      periods.&#xD;
&#xD;
      Treatment 1 requires all subjects to receive α-CD and a meal containing the fatty acid&#xD;
      radiotracers Treatment 2 requires all subjects to receive placebo and a meal containing the&#xD;
      fatty acid radiotracers All subjects will be observed for 48 hours as an in-patient, and a&#xD;
      further 24 hours as an out-patient following the meal containing the radiotracer and will&#xD;
      then undergo at least a further ≥ 14 day washout period before crossing over to the alternate&#xD;
      treatment.&#xD;
&#xD;
      All subjects randomized to the α-CD treatment arm will receive 2 g of α-CD (2 x 1 g tablets),&#xD;
      at each of three meals per day for 2 days. During the placebo phase, all subjects will&#xD;
      receive two identical-looking placebo tablets.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiolabeled lipid content in stool</measure>
    <time_frame>72 hours</time_frame>
    <description>The primary endpoint for this investigation is to measure the total excretion of radiolabeled fat in feces over 72 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood glucose levels</measure>
    <time_frame>6 hours</time_frame>
    <description>Blood Glucose will be measured hourly from fasting to 6 hours post radiotraced meal on the first day of each treatment period.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood Trigliceride Levels</measure>
    <time_frame>6 hours</time_frame>
    <description>Blood Triglyceride concentrations will be measured hourly from fasting to 6 hours post radiotraced meal on the first day of each treatment period</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Alpha-cycoldextrin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All subjects randomized to receive Alpha-cycoldextrin will orally ingest two tablets containing Alpha-cyclodextrin, with their standardized liquid breakfast (100 micro Ci of [3H]triolein and 20 micro Ci of [14C]tripalmitin). The tablets will be consumed with 150 ml of still 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. During this time they will undergo a meal fatty acid metabolism study, through blood and fecal sampling, to assess meal fatty acid oxidation and storage.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>All subjects randomized to receive placebo will orally ingest two placebo tablets with their standardized liquid breakfast (100 micro Ci of [3H]triolein and 20 micro Ci of [14C]tripalmitin). The tablets will be consumed with 150 ml of still 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. During this time they will undergo a meal fatty acid metabolism study, through blood and fecal sampling, to assess meal fatty acid oxidation and storage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Alpha-cyclodextrin</intervention_name>
    <description>Alpha-cyclodextrin (α-CD) is a soluble dietary fiber that has a history of use in foods and as a pharmaceutical excipient. Recently the ability of the fiber to bind to dietary fat has led to further investigation of the possible health benefits of dietary supplementation with this fiber.</description>
    <arm_group_label>Alpha-cycoldextrin</arm_group_label>
    <other_name>Calorease, Nuvexa, Mirafit, FBCx, Alfadex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Identical looking placebo tablet to active (Alpha-cyclodextrin)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy weight stable individuals (defined as a BMI of ≥18.5 and &lt;27, and stable for&#xD;
             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 - ≤60 years of age at screening&#xD;
&#xD;
          -  Consistent regular bowel movement (defined as between 3 times a day to 1 time per 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 Gilbert's&#xD;
             syndrome has previously been confirmed for the subject&#xD;
&#xD;
          -  Adequate bone marrow function: white blood cells (WBCs) ≥ 3,000/mm3, absolute&#xD;
             neutrophil count (ANC) ≥ 1,500/mm3, hemoglobin ≥ 9 g/dL, and platelets ≥ 100,000/mm3&#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 (per DSM4 criteria), bipolar disorder, or schizophrenia&#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 ≥ 30 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 components&#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, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>New South Wales</state>
        <zip>55905</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <results_reference>
    <citation>Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.</citation>
    <PMID>21127475</PMID>
  </results_reference>
  <results_reference>
    <citation>Jarosz PA, Fletcher E, Elserafy E, Artiss JD, Jen KL. The effect of alpha-cyclodextrin on postprandial lipid and glycemic responses to a fat-containing meal. Metabolism. 2013 Oct;62(10):1443-7. doi: 10.1016/j.metabol.2013.05.015. Epub 2013 Jun 24.</citation>
    <PMID>23806736</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</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/NCT02999620
org study id: SFIR-FMAT-US01
nct id: NCT02999620
lead sponsor: 
collaborator: 
has dmc: No
To determine the fat losses in stool associated with alpha-CD use in healthy volunteers, as
      compared to placebo when consumed with a standardized radiolabeled fatty meal.
This clinical investigation will determine the fat losses in stool associated with alpha-CD
      use as compared to placebo when ingested with a standardized liquid breakfast (100 microCi of
      [3H]triolein) and 20 microCi of [14C]tripalmitin). The ingested dose will be 2 g of α-CD at
      each of three meals per day for 2 days.

      Eight subjects will be recruited in a two-way crossover design consisting of two treatment
      periods.

      Treatment 1 requires all subjects to receive α-CD and a meal containing the fatty acid
      radiotracers Treatment 2 requires all subjects to receive placebo and a meal containing the
      fatty acid radiotracers All subjects will be observed for 48 hours as an in-patient, and a
      further 24 hours as an out-patient following the meal containing the radiotracer and will
      then undergo at least a further ≥ 14 day washout period before crossing over to the alternate
      treatment.

      All subjects randomized to the α-CD treatment arm will receive 2 g of α-CD (2 x 1 g tablets),
      at each of three meals per day for 2 days. During the placebo phase, all subjects will
      receive two identical-looking placebo tablets.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Radiolabeled lipid content in stool
time frame: 72 hours
description: The primary endpoint for this investigation is to measure the total excretion of radiolabeled fat in feces over 72 hours.
measure: Blood glucose levels
time frame: 6 hours
description: Blood Glucose will be measured hourly from fasting to 6 hours post radiotraced meal on the first day of each treatment period.
measure: Blood Trigliceride Levels
time frame: 6 hours
description: Blood Triglyceride concentrations will be measured hourly from fasting to 6 hours post radiotraced meal on the first day of each treatment period
arm group label: Alpha-cycoldextrin
arm group type: Active Comparator
description: All subjects randomized to receive Alpha-cycoldextrin will orally ingest two tablets containing Alpha-cyclodextrin, with their standardized liquid breakfast (100 micro Ci of [3H]triolein and 20 micro Ci of [14C]tripalmitin). The tablets will be consumed with 150 ml of still 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. During this time they will undergo a meal fatty acid metabolism study, through blood and fecal sampling, to assess meal fatty acid oxidation and storage.
arm group label: Placebo
arm group type: Placebo Comparator
description: All subjects randomized to receive placebo will orally ingest two placebo tablets with their standardized liquid breakfast (100 micro Ci of [3H]triolein and 20 micro Ci of [14C]tripalmitin). The tablets will be consumed with 150 ml of still 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. During this time they will undergo a meal fatty acid metabolism study, through blood and fecal sampling, to assess meal fatty acid oxidation and storage.
intervention type: Dietary Supplement
intervention name: Alpha-cyclodextrin
description: Alpha-cyclodextrin (α-CD) is a soluble dietary fiber that has a history of use in foods and as a pharmaceutical excipient. Recently the ability of the fiber to bind to dietary fat has led to further investigation of the possible health benefits of dietary supplementation with this fiber.
arm group label: Alpha-cycoldextrin
other name: Calorease, Nuvexa, Mirafit, FBCx, Alfadex
intervention type: Dietary Supplement
intervention name: Placebo
description: Identical looking placebo tablet to active (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, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: Australia
citation: Comerford KB, Artiss JD, Jen KL, Karakas SE. The beneficial effects of alpha-cyclodextrin on blood lipids and weight loss in healthy humans. Obesity (Silver Spring). 2011 Jun;19(6):1200-4. doi: 10.1038/oby.2010.280. Epub 2010 Dec 2.
PMID: 21127475
citation: Jarosz PA, Fletcher E, Elserafy E, Artiss JD, Jen KL. The effect of alpha-cyclodextrin on postprandial lipid and glycemic responses to a fat-containing meal. Metabolism. 2013 Oct;62(10):1443-7. doi: 10.1016/j.metabol.2013.05.015. Epub 2013 Jun 24.
PMID: 23806736
responsible party type: Sponsor
sharing ipd: No