<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/NCT03785821</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH104-REC3-014</org_study_id>
    <nct_id>NCT03785821</nct_id>
  </id_info>
  <brief_title>Effect of Bitter Melon Seed Oil on Body Weight</brief_title>
  <official_title>Development and Clinical Application of Bitter Melon Seed Oil as a Functional Food for Treating Obesity and Hepatic Steatosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the metabolic benefits of bitter melon seed oil (BMSO), overweight or obese&#xD;
      healthy Taiwanese adults (n=60) were randomly assigned to receive capsules containing either&#xD;
      olive oil (OO; placebo) or BMSO at 4.5 g/d dose for 12 week. Across intervention period, body&#xD;
      weight, BMI, waist-to-hip ratio, and body fat mass were measured. Blood were collected before&#xD;
      and after intervention for measurements of blood lipid and inflammatory cytokines. The&#xD;
      anti-obesity effect of BMSO was further assessed by stratification of participants according&#xD;
      to UCP1 rs1800592 polymorphism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bitter melon is a common Asian vegetable. Its seed is not edible and discarded as a waste&#xD;
      product. However, the seed oil is enriched in cis9, trans11, trans13-conjugated linolenic&#xD;
      acid or alpha-eleostearic acid (alpha-ESA). Investigators previously demonstrated the&#xD;
      anti-obesity functions of bitter melon seed oil (BMSO) in animal trials. Herein, a RCT was&#xD;
      conducted to test the potential of BMSO in developing as a functional culinary oil for weight&#xD;
      control.&#xD;
&#xD;
      Considering UCP-1 played a pivotal role in anti-adiposity function of BMSO as demonstrated in&#xD;
      animal studies, the anti-obesity effect of BMSO was further assessed according to UCP1&#xD;
      rs1800592 polymorphism.&#xD;
&#xD;
      Healthy Taiwanese adults with overweight or obesity were recruited by advertisement and were&#xD;
      assessed by a family medicine physician for eligibility. All participants signed the consent&#xD;
      form. Blocked randomization was used to randomly assign participants into one of two groups&#xD;
      to receive indicated supplement (BMSO or OO capsules with identical appearance; 4.5 g oil/d)&#xD;
      for 12 week. Subjects were requested to maintain their usual diet and physical activity&#xD;
      during the study period (0-12 week).&#xD;
&#xD;
      Anthropometric measurements were done on week 0, 4, 8 and 12. Three-day food records,&#xD;
      collection of blood samples and physical health check were conducted on week 0, 4 and 12.&#xD;
      Indirect calorimetry was done on week 0 and 12. Questionnaires about self-reported side&#xD;
      effects, such as trouble sleeping, constipation, diarrhea, increased heartbeat, palpitations,&#xD;
      headache, anxiety, or dizziness, were collected in each visit. Group allocation was&#xD;
      concealed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">April 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight gain</measure>
    <time_frame>12 week</time_frame>
    <description>Changes at intervention for 4,8 and 12 week</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>12 wk</time_frame>
    <description>Changes at intervention for 4,8 and 12 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist-to hip ratio</measure>
    <time_frame>12 wk</time_frame>
    <description>Changes at intervention for 4,8 and 12 week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body fat mass</measure>
    <time_frame>12 wk</time_frame>
    <description>Changes at intervention for 4,8 and 12 week</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Weight Gain</condition>
  <arm_group>
    <arm_group_label>BMSO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bitter melon seed oil supplementation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OO</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Olive oil supplementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>BMSO</intervention_name>
    <description>BMSO was extracted from Hualien No. 4 cultivate of bitter melon seed. BMSO were incorporated into capsules containing 0.5 g of oil. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily, resulting in daily consumption of 2.3 g alpha-ESA in the BMSO group.</description>
    <arm_group_label>BMSO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>OO</intervention_name>
    <description>Olive oil (extra virgin grade) was purchased from La Espanola (Acesur, Spain). OO were incorporated into capsules containing 0.5 g of oil, identical appearance to BMSO. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily.</description>
    <arm_group_label>OO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults with overweight or obesity (BMI ≥ 24 kg/m2 or waist circumference &gt; 90 cm in&#xD;
             males and &gt; 80 cm in females)&#xD;
&#xD;
          -  20-64 y of age&#xD;
&#xD;
          -  not currently using any weight-reducing agent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  endocrine disease&#xD;
&#xD;
          -  uncontrolled high blood pressure (systolic ≥ 180 mm Hg or diastolic ≥ 110 mm Hg)&#xD;
&#xD;
          -  liver, kidney, or cardiovascular disease&#xD;
&#xD;
          -  gastrointestinal disease&#xD;
&#xD;
          -  psychological diseases&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  asthma and allergies&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  use of any drugs or dietary supplements that potentially affected body weight, blood&#xD;
             lipids, blood pressure, or inflammatory responses.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pei-Min Chao, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>China Medical University, China</affiliation>
  </overall_official>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bitter melon seed oil</keyword>
  <keyword>Olive oil</keyword>
  <keyword>Weight control</keyword>
  <keyword>UCP1 polymorphism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Gain</mesh_term>
  </condition_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/NCT03785821
org study id: CMUH104-REC3-014
nct id: NCT03785821
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the metabolic benefits of bitter melon seed oil (BMSO), overweight or obese
      healthy Taiwanese adults (n=60) were randomly assigned to receive capsules containing either
      olive oil (OO; placebo) or BMSO at 4.5 g/d dose for 12 week. Across intervention period, body
      weight, BMI, waist-to-hip ratio, and body fat mass were measured. Blood were collected before
      and after intervention for measurements of blood lipid and inflammatory cytokines. The
      anti-obesity effect of BMSO was further assessed by stratification of participants according
      to UCP1 rs1800592 polymorphism.
Bitter melon is a common Asian vegetable. Its seed is not edible and discarded as a waste
      product. However, the seed oil is enriched in cis9, trans11, trans13-conjugated linolenic
      acid or alpha-eleostearic acid (alpha-ESA). Investigators previously demonstrated the
      anti-obesity functions of bitter melon seed oil (BMSO) in animal trials. Herein, a RCT was
      conducted to test the potential of BMSO in developing as a functional culinary oil for weight
      control.

      Considering UCP-1 played a pivotal role in anti-adiposity function of BMSO as demonstrated in
      animal studies, the anti-obesity effect of BMSO was further assessed according to UCP1
      rs1800592 polymorphism.

      Healthy Taiwanese adults with overweight or obesity were recruited by advertisement and were
      assessed by a family medicine physician for eligibility. All participants signed the consent
      form. Blocked randomization was used to randomly assign participants into one of two groups
      to receive indicated supplement (BMSO or OO capsules with identical appearance; 4.5 g oil/d)
      for 12 week. Subjects were requested to maintain their usual diet and physical activity
      during the study period (0-12 week).

      Anthropometric measurements were done on week 0, 4, 8 and 12. Three-day food records,
      collection of blood samples and physical health check were conducted on week 0, 4 and 12.
      Indirect calorimetry was done on week 0 and 12. Questionnaires about self-reported side
      effects, such as trouble sleeping, constipation, diarrhea, increased heartbeat, palpitations,
      headache, anxiety, or dizziness, were collected in each visit. Group allocation was
      concealed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Weight gain
time frame: 12 week
description: Changes at intervention for 4,8 and 12 week
measure: BMI
time frame: 12 wk
description: Changes at intervention for 4,8 and 12 week
measure: waist-to hip ratio
time frame: 12 wk
description: Changes at intervention for 4,8 and 12 week
measure: body fat mass
time frame: 12 wk
description: Changes at intervention for 4,8 and 12 week
arm group label: BMSO
arm group type: Experimental
description: Bitter melon seed oil supplementation
arm group label: OO
arm group type: Placebo Comparator
description: Olive oil supplementation
intervention type: Dietary Supplement
intervention name: BMSO
description: BMSO was extracted from Hualien No. 4 cultivate of bitter melon seed. BMSO were incorporated into capsules containing 0.5 g of oil. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily, resulting in daily consumption of 2.3 g alpha-ESA in the BMSO group.
arm group label: BMSO
intervention type: Dietary Supplement
intervention name: OO
description: Olive oil (extra virgin grade) was purchased from La Espanola (Acesur, Spain). OO were incorporated into capsules containing 0.5 g of oil, identical appearance to BMSO. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily.
arm group label: OO
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pei-Min Chao, PhD
role: Principal Investigator
affiliation: China Medical University, China
responsible party type: Sponsor
mesh term: Weight Gain
sharing ipd: No