<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/NCT03823157</url>
  </required_header>
  <id_info>
    <org_study_id>Tai Chi and eCB in women</org_study_id>
    <nct_id>NCT03823157</nct_id>
  </id_info>
  <brief_title>Tai Chi and eCB in Women</brief_title>
  <acronym>TC-eCB</acronym>
  <official_title>Tai Chi and eCB in Postmenopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</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 endocannabinoid system (ECS) is widely found in central and peripheral systems, and the&#xD;
      immune system. Moderate-intensity aerobic exercise has shown to increase circulatory&#xD;
      endocannabinoids. In this study, we will study Tai Chi, a mind-body moderate-intensity&#xD;
      exercise, intervention for its effects on ECS in women. A pre-post design trial will be&#xD;
      conducted on 18 qualified subjects. We will measure plasma eCB levels at baseline, before and&#xD;
      after 4th session of Tai Chi. All data will be analyzed statistically at p&lt;0.05.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the&#xD;
      immune system. Emerging studies have shown endocannabinoid plays a role in appetite, pain&#xD;
      sensation, control of chronic pain, macronutrient metabolism, mood/mood disorder, and&#xD;
      regulation of immune cell functions. Moderate-intensity aerobic exercise has shown to&#xD;
      increase circulatory endocannabinoids. Moderate-intensity exercise improves cognition,&#xD;
      memory, and wellbeing in adults. Exercisers experience decreased tension, depression, and&#xD;
      anger. Therefore, these findings in humans suggest a likely relationship for exercise&#xD;
      effecting well-being via ECS. In this study, we will study Tai Chi, a mind-body&#xD;
      moderate-intensity exercise, intervention for its effects on ECS in women. A pre-post design&#xD;
      trial will be conducted on 15 qualified subjects. All subjects will be assigned to Tai Chi&#xD;
      group for one week including 3 sessions, 60 minutes per session, on 3 non-consecutive days.&#xD;
      We will measure plasma eCB levels at baseline, before and after 4th session of Tai Chi. All&#xD;
      data will be analyzed statistically at p&lt;0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Tai Chi exercise</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>plasma eCB level</measure>
    <time_frame>1 week</time_frame>
    <description>AEA and 2-AG</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Mind-body Exercise</condition>
  <arm_group>
    <arm_group_label>Tai Chi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tai Chi exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi</intervention_name>
    <description>mind-body exercise</description>
    <arm_group_label>Tai Chi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Postmenopausal women (menopause is defined as the absence of menstrual period for 12&#xD;
             months, not related to pregnancy/lactation, hormonal contraception). Age 40-70 years&#xD;
             old with BMI between 25-35 kg/m2.&#xD;
&#xD;
          2. English literacy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. prior experience with mind-body practice (e.g., TC, Qi Gong, yoga, meditation).&#xD;
&#xD;
          2. Severe medical limitations (i.e., dementia, symptomatic heart or vascular disease, or&#xD;
             recent stroke) precluding full participation.&#xD;
&#xD;
          3. Medical/neurologic or other systemic diseases affecting the musculoskeletal systems&#xD;
             (i.e. polio/Parkinson's/ multiple sclerosis, etc. in addition to cerebral vascular&#xD;
             accident or stroke) and diabetes with peripheral neuropathy affecting their&#xD;
             sensory/balance.&#xD;
&#xD;
          4. taking pain/anti-inflammatory and sleep medications within the 3 months before study&#xD;
             starts.&#xD;
&#xD;
          5. taking hormone-replacement therapy within the 3 months before study starts.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chwan-li Shen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03823157
org study id: Tai Chi and eCB in women
nct id: NCT03823157
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the
      immune system. Moderate-intensity aerobic exercise has shown to increase circulatory
      endocannabinoids. In this study, we will study Tai Chi, a mind-body moderate-intensity
      exercise, intervention for its effects on ECS in women. A pre-post design trial will be
      conducted on 18 qualified subjects. We will measure plasma eCB levels at baseline, before and
      after 4th session of Tai Chi. All data will be analyzed statistically at p<0.05.
The endocannabinoid system (ECS) is widely found in central and peripheral systems, and the
      immune system. Emerging studies have shown endocannabinoid plays a role in appetite, pain
      sensation, control of chronic pain, macronutrient metabolism, mood/mood disorder, and
      regulation of immune cell functions. Moderate-intensity aerobic exercise has shown to
      increase circulatory endocannabinoids. Moderate-intensity exercise improves cognition,
      memory, and wellbeing in adults. Exercisers experience decreased tension, depression, and
      anger. Therefore, these findings in humans suggest a likely relationship for exercise
      effecting well-being via ECS. In this study, we will study Tai Chi, a mind-body
      moderate-intensity exercise, intervention for its effects on ECS in women. A pre-post design
      trial will be conducted on 15 qualified subjects. All subjects will be assigned to Tai Chi
      group for one week including 3 sessions, 60 minutes per session, on 3 non-consecutive days.
      We will measure plasma eCB levels at baseline, before and after 4th session of Tai Chi. All
      data will be analyzed statistically at p<0.05.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Tai Chi exercise
primary purpose: Other
masking: None (Open Label)
measure: plasma eCB level
time frame: 1 week
description: AEA and 2-AG
arm group label: Tai Chi
arm group type: Experimental
description: Tai Chi exercise
intervention type: Behavioral
intervention name: Tai Chi
description: mind-body exercise
arm group label: Tai Chi
criteria: 
gender: Female
gender based: Yes
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chwan-li Shen, PhD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center
facility: 
country: United States
responsible party type: Sponsor