xml: <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/NCT05990595</url>
    </required_header>
    <id_info>
      <org_study_id>202206033RINC</org_study_id>
      <nct_id>NCT05990595</nct_id>
    </id_info>
    <brief_title>Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control</brief_title>
    <acronym>ADL</acronym>
    <official_title>Evaluation of Health Effects of Adlay on Hyperlipidemia and Hyperglycemia Control (ADL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University 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>
        This study explores the efficacy of domestic adlay in improving blood sugar and lipids&#xD;
        metabolism, cardiovascular function, and weight control in people with high blood pressure,&#xD;
        hyperlipidemia, and hyperglycemia.&#xD;
  &#xD;
        Through two weeks of cooked adlay-rice and white rice by a randomized cross-over design to&#xD;
        evaluate the lipid- and glucose-lowering effects of adlay on patient with hyperlipidemia&#xD;
        and/or hyperglycemia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Evaluation of health effects of domestic adlay on lowering cholesterol and blood sugar&#xD;
  &#xD;
        Hyperlipidemia and diabetes are major risk factors for cardiovascular disease. Clinical&#xD;
        experiments have preliminarily proved that phytosterols can help lower blood lipids, and&#xD;
        adlay is one of the domestic economic crops that has animal experimental evidence or&#xD;
        theoretical potential to be beneficial to blood lipids and blood sugar control, which needs&#xD;
        to be further explored and verified. This study explores the efficacy of domestic adlay in&#xD;
        improving blood sugar and lipids metabolism, cardiovascular function, and weight control in&#xD;
        people with high blood pressure, hyperlipidemia, and hyperglycemia.&#xD;
  &#xD;
        We plan to recruit 60 patients with hyperglycemia or hyperlipidemia. aged between 20 and 80&#xD;
        years old, from National Taiwan University Hospital. This study is focused on high blood&#xD;
        cholesterol, triglycerides, and hyperglycemia groups, thus participants must have higher&#xD;
        cholesterol, triglycerides, or higher fasting blood glucose concentration even under&#xD;
        currently stable treatment for at least 6 months. Lipid-lowering and hypoglycemic medication&#xD;
        cannot be changed during this trial.&#xD;
  &#xD;
        The clinical trial adopts a randomized cross-over trial, the experimental group to eat white&#xD;
        rice with adlay and the control group to eat white rice. Participants in the project were&#xD;
        randomly divided into two groups, group A and B, with 30 people in each group. Group A eat&#xD;
        adlay to replace their carbohydrates: a box of 200 grams of rice (the amount of rice in dry&#xD;
        weight is 36 grams of adlay and 54 grams of white rice) per day; Group B ate a box of 200&#xD;
        grams of white rice (the amount of rice was 87 grams based on dry weight) per day. After the&#xD;
        first run of study, all participants resume to the original regular diet for two weeks, and&#xD;
        then switch groups for crossover trial after the two-week washout period. In the experiment,&#xD;
        during the crossover experiment, group A and group B replaced the experimental ingredients,&#xD;
        that is, the original white rice group was replaced by adlay with white rice, and the&#xD;
        original adlay and white rice group was replaced with white rice for a period of two weeks.&#xD;
        To ensure that the test material is homogeneous and uniform, the white rice with adlay is&#xD;
        made from the &quot;cooked rice with adlay&quot; produced by Nanqiao Group, HUACIANG INDUSTRY CO., LTD.&#xD;
        The adlay cooked rice contains 40% adlay and Taichung No. 194 white rice 60%, and the control&#xD;
        group used Taichung No. 194 white rice.&#xD;
  &#xD;
        Every participant have to receive blood and urine sampling for biochemical measurement in&#xD;
        each stage, 1. Baseline, 2. Two weeks after first stage: adlay with white rice or white rice,&#xD;
        3. Washed period stage for 2 weeks, 4. Two weeks after crossover stage. The main results&#xD;
        analysis includes fasting blood sugar,glycosylated hemoglobin, glycosylated hemoglobin,&#xD;
        triglycerides, total cholesterol, high-density cholesterol, and low-density cholesterol.&#xD;
        Secondary outcome analysis includes blood pressure, body composition analysis, inflammation&#xD;
        index, thyroid function, levels of intestinal hormones (cholecystokinin, gastrin) and&#xD;
        glucagon-like peptide-1, and other emerging blood lipid indicators, such as small-dense&#xD;
        LDL-C. The above measurements will be performed every 2 weeks for each stage. Pittsburgh&#xD;
        Sleep Quality Index and Center for Epidemiological Studies Depression Scale (CES-D) will also&#xD;
        be assessed every 2 weeks for each stage.&#xD;
  &#xD;
        Keywords: hyperlipidemia, hyperglycemia, diabetes mellitus, randomized crossover trial&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 7, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 28, 2023</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>
      <intervention_model_description>The clinical trial adopts a randomized cross-over trial, the experimental group to eat white rice with adlay and the control group to eat white rice. Participants in the project were randomly divided into two groups, group A and B, with 30 people in each group. Group A eat 200 gm cooked adlay with white rice to replace their carbohydrates; Group B ate a box of 200 grams of white rice per day. After the first run of study, all participants resume to the original regular diet for two weeks, and then switch groups for crossover trial after the two-week washout period. In the experiment, during the crossover experiment, group A and group B replaced the experimental ingredients, that is, the original white rice group was replaced by adlay with white rice, and the original adlay and white rice group was replaced with white rice for a period of two weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Fasting blood glucose</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>glucose-lowering effects</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cholesterol</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Lipids</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HDL-cholesterol</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Lipids</description>
    </primary_outcome>
    <primary_outcome>
      <measure>LDL-cholesterol</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Lipids</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Lipids</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Glycosylated hemoglobin (HbA1C)</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Hemoglobin A1C is a form of hemoglobin (Hb) that is chemically linked to sugar</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>physiological biomarkers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body composition</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>The percentages of fat, bone and muscle in human bodies by bioelectric impedance technology</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hs-CRP (high sensitivity C-reactive protein)</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Inflammation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Free T4 and TSH (Thyroid Stimulating Hormone)</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Thyroid function tests</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insulin</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>A peptide hormone produced by beta cells of the pancreatic islets</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastrin, Cholecystokinine, and Glucagon-like peptide 1</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Intestin Hormones</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Small-dense LDL-cholesterol</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>LDL subpopulation particles</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pittsburgh Sleep Quality Index</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Sleep quality assessment</description>
    </other_outcome>
    <other_outcome>
      <measure>Center for Epidemiologic Studies Depression Scale (CES-D), NIMH</measure>
      <time_frame>2 weeks for each stage</time_frame>
      <description>Depression scale assessment</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Hyperlipidemia</condition>
    <condition>Hyperglycemia</condition>
    <condition>Type 2 Diabetes</condition>
    <arm_group>
      <arm_group_label>Adlay with white rice</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group A eat cooked adlay with white rice to replace their carbohydrates: a box of 200 grams of adlay rice per day</description>
    </arm_group>
    <arm_group>
      <arm_group_label>White rice</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Group B ate a box of 200 grams of cooked white rice per day</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Adlay with white rice</intervention_name>
      <description>We will investigate the lipid- and glucose-lowering effects of Adlay rice in comparison to white rice through a randomized cross-over trial.</description>
      <arm_group_label>Adlay with white rice</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>white rice</intervention_name>
      <description>white rice</description>
      <arm_group_label>White rice</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Hyperlipidemia: Levels of LDL-choleterol equal or greater than 130 mg/dL, or&#xD;
               triglyceride equal or greater than 150 mg/dL&#xD;
  &#xD;
            2. Hyperglycemia: fasting glucose equal or greater than 100 mg/dL&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Secondary hyperglycemia Secondary hyperlipidemia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ta-Chen Su, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ta-Chen Su, MD, PhD</last_name>
      <phone>+886-972651062</phone>
      <email>tachensu@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cheng-Yu Chiang, MSc</last_name>
      <phone>+886-965813735</phone>
      <email>oldchiang@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <zip>10002</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ta-Chen Su, MD, PhD</last_name>
        <phone>+886-972651062</phone>
        <email>tachensu@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Cheng-Yu Chiang, MSc</last_name>
        <phone>+886-965813735</phone>
        <email>oldchiang@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ta-Chen Su, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adlay, Hyperlipidemia, Hyperglycemia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyperglycemia</mesh_term>
      <mesh_term>Hyperlipidemias</mesh_term>
      <mesh_term>Hyperlipoproteinemias</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990595
  org study id: 202206033RINC
  nct id: NCT05990595
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study explores the efficacy of domestic adlay in improving blood sugar and lipids
        metabolism, cardiovascular function, and weight control in people with high blood pressure,
        hyperlipidemia, and hyperglycemia.
  
        Through two weeks of cooked adlay-rice and white rice by a randomized cross-over design to
        evaluate the lipid- and glucose-lowering effects of adlay on patient with hyperlipidemia
        and/or hyperglycemia.
  Evaluation of health effects of domestic adlay on lowering cholesterol and blood sugar
  
        Hyperlipidemia and diabetes are major risk factors for cardiovascular disease. Clinical
        experiments have preliminarily proved that phytosterols can help lower blood lipids, and
        adlay is one of the domestic economic crops that has animal experimental evidence or
        theoretical potential to be beneficial to blood lipids and blood sugar control, which needs
        to be further explored and verified. This study explores the efficacy of domestic adlay in
        improving blood sugar and lipids metabolism, cardiovascular function, and weight control in
        people with high blood pressure, hyperlipidemia, and hyperglycemia.
  
        We plan to recruit 60 patients with hyperglycemia or hyperlipidemia. aged between 20 and 80
        years old, from National Taiwan University Hospital. This study is focused on high blood
        cholesterol, triglycerides, and hyperglycemia groups, thus participants must have higher
        cholesterol, triglycerides, or higher fasting blood glucose concentration even under
        currently stable treatment for at least 6 months. Lipid-lowering and hypoglycemic medication
        cannot be changed during this trial.
  
        The clinical trial adopts a randomized cross-over trial, the experimental group to eat white
        rice with adlay and the control group to eat white rice. Participants in the project were
        randomly divided into two groups, group A and B, with 30 people in each group. Group A eat
        adlay to replace their carbohydrates: a box of 200 grams of rice (the amount of rice in dry
        weight is 36 grams of adlay and 54 grams of white rice) per day; Group B ate a box of 200
        grams of white rice (the amount of rice was 87 grams based on dry weight) per day. After the
        first run of study, all participants resume to the original regular diet for two weeks, and
        then switch groups for crossover trial after the two-week washout period. In the experiment,
        during the crossover experiment, group A and group B replaced the experimental ingredients,
        that is, the original white rice group was replaced by adlay with white rice, and the
        original adlay and white rice group was replaced with white rice for a period of two weeks.
        To ensure that the test material is homogeneous and uniform, the white rice with adlay is
        made from the "cooked rice with adlay" produced by Nanqiao Group, HUACIANG INDUSTRY CO., LTD.
        The adlay cooked rice contains 40% adlay and Taichung No. 194 white rice 60%, and the control
        group used Taichung No. 194 white rice.
  
        Every participant have to receive blood and urine sampling for biochemical measurement in
        each stage, 1. Baseline, 2. Two weeks after first stage: adlay with white rice or white rice,
        3. Washed period stage for 2 weeks, 4. Two weeks after crossover stage. The main results
        analysis includes fasting blood sugar,glycosylated hemoglobin, glycosylated hemoglobin,
        triglycerides, total cholesterol, high-density cholesterol, and low-density cholesterol.
        Secondary outcome analysis includes blood pressure, body composition analysis, inflammation
        index, thyroid function, levels of intestinal hormones (cholecystokinin, gastrin) and
        glucagon-like peptide-1, and other emerging blood lipid indicators, such as small-dense
        LDL-C. The above measurements will be performed every 2 weeks for each stage. Pittsburgh
        Sleep Quality Index and Center for Epidemiological Studies Depression Scale (CES-D) will also
        be assessed every 2 weeks for each stage.
  
        Keywords: hyperlipidemia, hyperglycemia, diabetes mellitus, randomized crossover trial
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: The clinical trial adopts a randomized cross-over trial, the experimental group to eat white rice with adlay and the control group to eat white rice. Participants in the project were randomly divided into two groups, group A and B, with 30 people in each group. Group A eat 200 gm cooked adlay with white rice to replace their carbohydrates; Group B ate a box of 200 grams of white rice per day. After the first run of study, all participants resume to the original regular diet for two weeks, and then switch groups for crossover trial after the two-week washout period. In the experiment, during the crossover experiment, group A and group B replaced the experimental ingredients, that is, the original white rice group was replaced by adlay with white rice, and the original adlay and white rice group was replaced with white rice for a period of two weeks.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Fasting blood glucose
  time frame: 2 weeks for each stage
  description: glucose-lowering effects
  measure: Cholesterol
  time frame: 2 weeks for each stage
  description: Lipids
  measure: HDL-cholesterol
  time frame: 2 weeks for each stage
  description: Lipids
  measure: LDL-cholesterol
  time frame: 2 weeks for each stage
  description: Lipids
  measure: Triglycerides
  time frame: 2 weeks for each stage
  description: Lipids
  measure: Glycosylated hemoglobin (HbA1C)
  time frame: 2 weeks for each stage
  description: Hemoglobin A1C is a form of hemoglobin (Hb) that is chemically linked to sugar
  measure: Blood pressure
  time frame: 2 weeks for each stage
  description: physiological biomarkers
  measure: Body composition
  time frame: 2 weeks for each stage
  description: The percentages of fat, bone and muscle in human bodies by bioelectric impedance technology
  measure: hs-CRP (high sensitivity C-reactive protein)
  time frame: 2 weeks for each stage
  description: Inflammation
  measure: Free T4 and TSH (Thyroid Stimulating Hormone)
  time frame: 2 weeks for each stage
  description: Thyroid function tests
  measure: Insulin
  time frame: 2 weeks for each stage
  description: A peptide hormone produced by beta cells of the pancreatic islets
  measure: Gastrin, Cholecystokinine, and Glucagon-like peptide 1
  time frame: 2 weeks for each stage
  description: Intestin Hormones
  measure: Small-dense LDL-cholesterol
  time frame: 2 weeks for each stage
  description: LDL subpopulation particles
  measure: Pittsburgh Sleep Quality Index
  time frame: 2 weeks for each stage
  description: Sleep quality assessment
  measure: Center for Epidemiologic Studies Depression Scale (CES-D), NIMH
  time frame: 2 weeks for each stage
  description: Depression scale assessment
  arm group label: Adlay with white rice
  arm group type: Experimental
  description: Group A eat cooked adlay with white rice to replace their carbohydrates: a box of 200 grams of adlay rice per day
  arm group label: White rice
  arm group type: Placebo Comparator
  description: Group B ate a box of 200 grams of cooked white rice per day
  intervention type: Dietary Supplement
  intervention name: Adlay with white rice
  description: We will investigate the lipid- and glucose-lowering effects of Adlay rice in comparison to white rice through a randomized cross-over trial.
  arm group label: Adlay with white rice
  intervention type: Dietary Supplement
  intervention name: white rice
  description: white rice
  arm group label: White rice
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ta-Chen Su, MD, PhD
  role: Principal Investigator
  affiliation: National Taiwan University Hospital
  last name: Ta-Chen Su, MD, PhD
  phone: +886-972651062
  email: tachensu@gmail.com
  last name: Cheng-Yu Chiang, MSc
  phone: +886-965813735
  email: oldchiang@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Hyperglycemia
  mesh term: Hyperlipidemias
  mesh term: Hyperlipoproteinemias