<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/NCT01709955</url>
  </required_header>
  <id_info>
    <org_study_id>10-13</org_study_id>
    <nct_id>NCT01709955</nct_id>
  </id_info>
  <brief_title>The Effects of Glucomannan on Weight Loss</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northeast College of Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northeast College of Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the herb, Glucomannan, is an effective&#xD;
      non-pharmacological appetite suppressant for overweight or Class I obese patients. The study&#xD;
      design will not include any other lifestyle changes which enhance weight loss in order to&#xD;
      completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">July 2011</completion_date>
  <primary_completion_date type="Actual">July 2011</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>30 Days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Gucomannan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Glucomannan</intervention_name>
    <description>750 MG of Glucomannan in capsule form</description>
    <arm_group_label>Gucomannan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>750 mg of Cellulose powder in a capsule form</description>
    <arm_group_label>Placebo pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Subjects will be recruited based upon the category of them wanting to&#xD;
        lose 50 pounds.&#xD;
&#xD;
        Subjects must be able to swallow the capsule whole with water.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Self-reported use of prescription medication other than hormonal birth control (such&#xD;
             as medication for diabetes, hypertension hypothyroidism, heart disease, cancer, etc.)&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Age younger than 21 or older than 60 years of age.&#xD;
&#xD;
          4. Screening for hypertension during the first laboratory visit that reveals a systole&#xD;
             greater than 120 and a diastole greater than 90.&#xD;
&#xD;
          5. BMI calculations based upon height and weight measurements at the first laboratory&#xD;
             visit that reveal a BMI less than 25 or greater than 35.&#xD;
&#xD;
          6. Self-reported iron-deficiency anemia, osteoporosis, and hypoglycemia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northeast College of Health Sciences</investigator_affiliation>
    <investigator_full_name>Denise Holtzman MS DC</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Overweight</keyword>
  <keyword>Glucomannan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>(1-6)-alpha-glucomannan</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01709955
org study id: 10-13
nct id: NCT01709955
lead sponsor: 
has dmc: No
The purpose of this study is to determine if the herb, Glucomannan, is an effective
      non-pharmacological appetite suppressant for overweight or Class I obese patients. The study
      design will not include any other lifestyle changes which enhance weight loss in order to
      completely isolate the effects of Glucomannan as a non-pharmacological appetite suppressant.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Weight Loss
time frame: 30 Days
arm group label: Gucomannan
arm group type: Experimental
arm group label: Placebo pill
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Glucomannan
description: 750 MG of Glucomannan in capsule form
arm group label: Gucomannan
intervention type: Other
intervention name: Placebo
description: 750 mg of Cellulose powder in a capsule form
arm group label: Placebo pill
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Northeast College of Health Sciences
investigator full name: Denise Holtzman MS DC
investigator title: Associate professor
mesh term: Obesity
mesh term: (1-6)-alpha-glucomannan