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/NCT05997628</url>
    </required_header>
    <id_info>
      <org_study_id>CH2301-A-01</org_study_id>
      <nct_id>NCT05997628</nct_id>
    </id_info>
    <brief_title>The Exploratory Study on the Baseline Level of NAD+/NADH in Peripheral Blood Samples of Different Gender and Age Groups of Healthy Adults.</brief_title>
    <official_title>The Exploratory Study on the Baseline Level of NAD+/NADH in Peripheral Blood Samples of Different Gender and Age Groups of Healthy Adults.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Cell Therapy Group Co.,Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shanghai Mengchao Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Shanghai Cell Therapy Group Co.,Ltd</source>
    <oversight_info>
      <has_dmc>Yes</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 investigates the concentration levels of NAD+/NADH in peripheral blood samples and&#xD;
        immune cells of healthy adults of different age groups under daily physiological and&#xD;
        lifestyle conditions, in order to determine the baseline levels of NAD+/NADH in adult&#xD;
        populations of different age groups and genders. Simultaneously examining the biological&#xD;
        status and function of human immune cells, blood biochemistry, biological age levels, to&#xD;
        explore the biological function and mechanism of NAD+/NADH in the aging process of the human&#xD;
        body.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this study, 60 subjects will be enrolled in three groups according to the age range of&#xD;
        20-40, 41-60 and 61-80. Each group has 20 subjects, and the sex ratio of each group is 1:1.&#xD;
        After each participant is enrolled, peripheral blood samples are taken before breakfast and&#xD;
        before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological&#xD;
        baseline levels of NAD+/NADH in different age groups. At the same time, the subjects tested&#xD;
        Hematology, blood biochemical indicators, as well as the expression of subsets of peripheral&#xD;
        blood immune cells and SIRT1 level at the same time point, to study the change trend of&#xD;
        NAD+/NADH level in different age groups, and the correlation between this trend and&#xD;
        Hematology age, immune indicators.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The baseline in NAD+ and NADH concentrations in whole blood of healthy adults.</measure>
      <time_frame>Fasting at 0 hour, 4 hour on the day of the trial</time_frame>
      <description>Monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Counting of blood cell indicators such as red blood cells, white blood cells, and platelets in healthy adults</measure>
      <time_frame>Fasting at 0 hour on the day of the trial</time_frame>
      <description>Monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood biochemical indicators of the healthy adults monitoring including liver function; lood lipids; blood sugar; renal function; uric acid; lactate dehydrogenase; creatine kinase, etc</measure>
      <time_frame>Fasting at 0 hour on the day of the trial</time_frame>
      <description>Monitor</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peripheral blood immune cell phenotype of the healthy adults monitoring including NK cells, B lymphocytes, eosinophils, T lymphocytes, platelet neutrophils, basophils, and monocytes, etc</measure>
      <time_frame>Fasting at 0 hour on the day of the trial</time_frame>
      <description>Monitor</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>NAD+/NADH in Peripheral Blood Monitoring</condition>
    <arm_group>
      <arm_group_label>18-40 years</arm_group_label>
      <description>Each group has 20 subjects, and the sex ratio of 18-40 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups</description>
    </arm_group>
    <arm_group>
      <arm_group_label>41-60 years</arm_group_label>
      <description>Each group has 20 subjects, and the sex ratio of 41-60 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups</description>
    </arm_group>
    <arm_group>
      <arm_group_label>61-80 years</arm_group_label>
      <description>Each group has 20 subjects, and the sex ratio of 61-80 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Detection of NAD+/NADH concentration of Peripheral Blood Samples</intervention_name>
      <description>Peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels, hematology, blood biochemical indicators, immune cells and SIRT1 level in peripheral blood in different age groups. This experiment monitors indicators mentioned above without any drug intervention.</description>
      <arm_group_label>18-40 years</arm_group_label>
      <arm_group_label>41-60 years</arm_group_label>
      <arm_group_label>61-80 years</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy adults of different age groups under daily physiological and lifestyle conditions&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Male/females of 18 to 85 years of age.&#xD;
  &#xD;
               2. Able to provide written Informed Consent.&#xD;
  &#xD;
               3. Body Mass Index ranging from 18 to 25 kg/m2(bounds included), with a stable weight&#xD;
               over the last 2 months (±2.5 kg).&#xD;
  &#xD;
               4. Able to follow verbal and written study directions.&#xD;
  &#xD;
               5. Must not be taking or be willing to take any supplements containing any form of&#xD;
               niacin for seven days prior to baseline and for the duration of the study.&#xD;
  &#xD;
               6.Able to maintain consistent diet and lifestyle habits according to the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Male/females of 18 to 85 years of age.&#xD;
  &#xD;
               2. Able to provide written Informed Consent.&#xD;
  &#xD;
               3. Body Mass Index ranging from 18 to 25 kg/m2(bounds included), with a stable weight&#xD;
               over the last 2 months (±2.5 kg).&#xD;
  &#xD;
               4. Able to follow verbal and written study directions.&#xD;
  &#xD;
               5. Must not be taking or be willing to take any supplements containing any form of&#xD;
               niacin for seven days prior to baseline and for the duration of the study.&#xD;
  &#xD;
               6. Able to maintain consistent diet and lifestyle habits according to the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zongchang Song</last_name>
      <phone>13703785735</phone>
      <email>songzc@shcell.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>shuan Liu</last_name>
      <phone>17749122881</phone>
      <email>liushuan@shcell.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shanghai Mengchao Cancer Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>zongchang SONG</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NADH</keyword>
    <keyword>NAD+</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </patient_data>
    <!-- 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/NCT05997628
  org study id: CH2301-A-01
  nct id: NCT05997628
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study investigates the concentration levels of NAD+/NADH in peripheral blood samples and
        immune cells of healthy adults of different age groups under daily physiological and
        lifestyle conditions, in order to determine the baseline levels of NAD+/NADH in adult
        populations of different age groups and genders. Simultaneously examining the biological
        status and function of human immune cells, blood biochemistry, biological age levels, to
        explore the biological function and mechanism of NAD+/NADH in the aging process of the human
        body.
  In this study, 60 subjects will be enrolled in three groups according to the age range of
        20-40, 41-60 and 61-80. Each group has 20 subjects, and the sex ratio of each group is 1:1.
        After each participant is enrolled, peripheral blood samples are taken before breakfast and
        before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological
        baseline levels of NAD+/NADH in different age groups. At the same time, the subjects tested
        Hematology, blood biochemical indicators, as well as the expression of subsets of peripheral
        blood immune cells and SIRT1 level at the same time point, to study the change trend of
        NAD+/NADH level in different age groups, and the correlation between this trend and
        Hematology age, immune indicators.
  observational model: Cohort
  time perspective: Other
  measure: The baseline in NAD+ and NADH concentrations in whole blood of healthy adults.
  time frame: Fasting at 0 hour, 4 hour on the day of the trial
  description: Monitor
  measure: Counting of blood cell indicators such as red blood cells, white blood cells, and platelets in healthy adults
  time frame: Fasting at 0 hour on the day of the trial
  description: Monitor
  measure: Blood biochemical indicators of the healthy adults monitoring including liver function; lood lipids; blood sugar; renal function; uric acid; lactate dehydrogenase; creatine kinase, etc
  time frame: Fasting at 0 hour on the day of the trial
  description: Monitor
  measure: Peripheral blood immune cell phenotype of the healthy adults monitoring including NK cells, B lymphocytes, eosinophils, T lymphocytes, platelet neutrophils, basophils, and monocytes, etc
  time frame: Fasting at 0 hour on the day of the trial
  description: Monitor
  arm group label: 18-40 years
  description: Each group has 20 subjects, and the sex ratio of 18-40 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups
  arm group label: 41-60 years
  description: Each group has 20 subjects, and the sex ratio of 41-60 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups
  arm group label: 61-80 years
  description: Each group has 20 subjects, and the sex ratio of 61-80 years group is 1:1. After each participant is enrolled, peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels in peripheral blood and determine the physiological baseline levels of NAD+/NADH in different age groups
  intervention type: Other
  intervention name: Detection of NAD+/NADH concentration of Peripheral Blood Samples
  description: Peripheral blood samples are taken before breakfast and before lunch to detect NAD+/NADH levels, hematology, blood biochemical indicators, immune cells and SIRT1 level in peripheral blood in different age groups. This experiment monitors indicators mentioned above without any drug intervention.
  arm group label: 18-40 years
  arm group label: 41-60 years
  arm group label: 61-80 years
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zongchang Song
  phone: 13703785735
  email: songzc@shcell.com
  last name: shuan Liu
  phone: 17749122881
  email: liushuan@shcell.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: Yes
  ipd info type: Clinical Study Report (CSR)