<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/NCT04429737</url>
  </required_header>
  <id_info>
    <org_study_id>Chang Gung IRB 201601965A3</org_study_id>
    <nct_id>NCT04429737</nct_id>
  </id_info>
  <brief_title>The Effects of Freshwater Clam Extract on Blood Sugar, and Lipid Profile in Prediabetes Patients</brief_title>
  <official_title>Department of Traditional Chinese Medicine, Keelung Chang Gung Memorial Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zhao Hong Biotechnology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chang Gung Memorial Hospital</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 purpose of this study is to determine whether the freshwater clam extract and its&#xD;
      combination is effective on the improvement of glucose and lipid metabolism, also evaluate&#xD;
      its ability to postpone prediabetes patients to become diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the effect of freshwater clam extract and its combination is&#xD;
      effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability&#xD;
      to postpone prediabetes patients to become diabetes., 3 month and 6 month data will be&#xD;
      collected and put into analysis to provide some suggestions on the Clam protein capsules and&#xD;
      Clam peptide plus Chlorella capsules use in the clinical practice for prediabetes patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the change in lipid profile relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in lipid profile relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in inflammation index relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in inflammation index relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in HbA1C (%) relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in HbA1C (%) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in HbA1C (%) relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in HbA1C (%) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in fasting glucose (mg/dl) relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in fasting glucose (mg/dl) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in fasting glucose (mg/dl) relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in fasting glucose (mg/dl) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in liver function relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in liver function relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in renal function relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in Bun(mg/dL),Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in renal function relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in Albumin (g/L) relative to baseline</measure>
    <time_frame>3 months</time_frame>
    <description>Assessment of the change in Albumin (g/L) relative to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of the change in Albumin (g/L) relative to baseline</measure>
    <time_frame>6 months</time_frame>
    <description>Assessment of the change in Albumin (g/L) relative to baseline</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Prediabetes</condition>
  <condition>Metabolic Diseases</condition>
  <condition>Glucose Metabolism Disorders</condition>
  <condition>Dietary Supplement</condition>
  <condition>Nutrition</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The prediabetes patients in this arm will receive Clam protein capsules or Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>clam protein capsules</intervention_name>
    <description>The prediabetes patients in this arm will receive Clam protein capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Clam peptide plus Chlorella capsules</intervention_name>
    <description>The prediabetes patients in this arm will receive Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The prediabetes patients in this arm will receive Placebo with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Agree to cooperate in the trial and sign the written informed consent&#xD;
&#xD;
          2. Age 25-70 years&#xD;
&#xD;
          3. Glucose AC between 100-125 mg/dL&#xD;
&#xD;
          4. HbA1c between 5.7%~6.4%&#xD;
&#xD;
          5. Total Cholesterol≧160mg/dL or LDL-C≧100mg/dL Remark: Meet one of the (3)~(5)&#xD;
             conditions is acceptable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant and lactating women&#xD;
&#xD;
          2. Poor medication compliance&#xD;
&#xD;
          3. Abnormal liver function patients (ALT and AST value&gt; 2 folds of normal value upper&#xD;
             limit )&#xD;
&#xD;
          4. Abnormal renal function patients (creatinine value&gt;1.5 mg/dL)&#xD;
&#xD;
          5. Abnormal gastrointestinal function patients (eg. gastrostomy, enterostomy, and&#xD;
             diarrhea)&#xD;
&#xD;
          6. Sever comorbidity in the last 6 months. (eg. Brain stroke, myocardial infarction, and&#xD;
             major trauma and surgery)&#xD;
&#xD;
          7. Using influence blood sugar, blood pressure, and blood lipid drugs (eg sex hormones,&#xD;
             corticosteroids, H2 blockers, diuretics and Statin )&#xD;
&#xD;
          8. Diabetes patients&#xD;
&#xD;
          9. Other sever diseases ( malignant tumor and alzheimer's disease)&#xD;
&#xD;
         10. With inflammatory diseases, infectious disease, and severe immune deficiency ( eg.&#xD;
             tuberculosis, AIDS, active pneumonia, systemic lupus erythematosus and rheumatoid&#xD;
             arthritis)&#xD;
&#xD;
         11. Other influence blood sugar endocrine disease (eg. Hyperthyroidism, Acromegaly,&#xD;
             Cushing's syndrome and Pheochromocytoma)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TSE-HUNG HUANG, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for traditional chinese medicine, Chang Gung Memorial Hospital</name>
      <address>
        <city>Gueishan Township</city>
        <state>Taoyuan County</state>
        <zip>33378</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TSE-HUNG HUANG MD PhD</name>
      <address>
        <city>Keelung</city>
        <zip>204</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prediabetes</keyword>
  <keyword>Glucose Metabolism Disorders</keyword>
  <keyword>Metabolic Diseases</keyword>
  <keyword>Clam protein capsules</keyword>
  <keyword>Clam peptide</keyword>
  <keyword>Clam amino capsules</keyword>
  <keyword>clam extract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Glucose Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04429737
org study id: Chang Gung IRB 201601965A3
nct id: NCT04429737
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether the freshwater clam extract and its
      combination is effective on the improvement of glucose and lipid metabolism, also evaluate
      its ability to postpone prediabetes patients to become diabetes.
This study aims to evaluate the effect of freshwater clam extract and its combination is
      effective on the improvement of glucose and lipid metabolism, as well as evaluate its ability
      to postpone prediabetes patients to become diabetes., 3 month and 6 month data will be
      collected and put into analysis to provide some suggestions on the Clam protein capsules and
      Clam peptide plus Chlorella capsules use in the clinical practice for prediabetes patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Assessment of the change in lipid profile relative to baseline
time frame: 3 months
description: Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline
measure: Assessment of the change in lipid profile relative to baseline
time frame: 6 months
description: Assessment of the change in Total Cholesterol(mg/dL), Triglyceride(mg/dL), low density lipoprotein (mg/dL) relative to baseline
measure: Assessment of the change in inflammation index relative to baseline
time frame: 3 months
description: Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline
measure: Assessment of the change in inflammation index relative to baseline
time frame: 6 months
description: Assessment of the change in TNF-alpha (pg/ml) and hs-CRP(pg/ml) relative to baseline
measure: Assessment of the change in HbA1C (%) relative to baseline
time frame: 3 months
description: Assessment of the change in HbA1C (%) relative to baseline
measure: Assessment of the change in HbA1C (%) relative to baseline
time frame: 6 months
description: Assessment of the change in HbA1C (%) relative to baseline
measure: Assessment of the change in fasting glucose (mg/dl) relative to baseline
time frame: 3 months
description: Assessment of the change in fasting glucose (mg/dl) relative to baseline
measure: Assessment of the change in fasting glucose (mg/dl) relative to baseline
time frame: 6 months
description: Assessment of the change in fasting glucose (mg/dl) relative to baseline
measure: Assessment of the change in liver function relative to baseline
time frame: 3 months
description: Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline
measure: Assessment of the change in liver function relative to baseline
time frame: 6 months
description: Assessment of the change in ALT (U/L) and AST(U/L) relative to baseline
measure: Assessment of the change in renal function relative to baseline
time frame: 3 months
description: Assessment of the change in Bun(mg/dL),Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline
measure: Assessment of the change in renal function relative to baseline
time frame: 6 months
description: Assessment of the change in Bun(mg/dL), Uric acid(mg/dL) and Creatinine(mg/dL) relative to baseline
measure: Assessment of the change in Albumin (g/L) relative to baseline
time frame: 3 months
description: Assessment of the change in Albumin (g/L) relative to baseline
measure: Assessment of the change in Albumin (g/L) relative to baseline
time frame: 6 months
description: Assessment of the change in Albumin (g/L) relative to baseline
arm group label: Experimental
arm group type: Experimental
description: The prediabetes patients in this arm will receive Clam protein capsules or Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months.
arm group label: placebo
arm group type: Placebo Comparator
description: The prediabetes patients in this arm will receive placebo with similar appearance of Clam protein capsules or Clam peptide plus Chlorella capsules.
intervention type: Dietary Supplement
intervention name: clam protein capsules
description: The prediabetes patients in this arm will receive Clam protein capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
arm group label: Experimental
intervention type: Dietary Supplement
intervention name: Clam peptide plus Chlorella capsules
description: The prediabetes patients in this arm will receive Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
arm group label: Experimental
intervention type: Dietary Supplement
intervention name: Placebo
description: The prediabetes patients in this arm will receive Placebo with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
arm group label: placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: TSE-HUNG HUANG, MD PhD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Prediabetic State
mesh term: Glucose Intolerance
mesh term: Metabolic Diseases
mesh term: Glucose Metabolism Disorders
sharing ipd: Undecided