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/NCT06030362</url>
    </required_header>
    <id_info>
      <org_study_id>IRB 22-000796</org_study_id>
      <nct_id>NCT06030362</nct_id>
    </id_info>
    <brief_title>Probiotic Intervention Study</brief_title>
    <official_title>Double Blinded Placebo Controlled Feasibility Study to Evaluate a Combination Probiotic in Adults With Obesity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Los Angeles</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Los Angeles</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 current standard of care for obesity is the optimal management of comorbid conditions&#xD;
        such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased&#xD;
        physical activity programs. However, lifestyle, diet, and behavioral interventions may&#xD;
        provide between 7-10% reduction in initial weight and even fewer with long-term weight loss.&#xD;
        In severely obese patients (BMI&gt;40 or BMI&gt;35 with comorbidities), bariatric surgery is also a&#xD;
        potential treatment, but there is a high barrier for patients to undergo surgery for weight&#xD;
        loss. These barriers include an aversion to major abdominal surgery, long recovery time,&#xD;
        potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there&#xD;
        is a paramount need for other treatments for obesity and for food addiction.&#xD;
  &#xD;
        The current standard of care for obesity and food addiction is difficult to implement and&#xD;
        lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack&#xD;
        sustained weight loss, and engage in the well-known &quot;YoYo&quot; diet phenomenon. While bariatric&#xD;
        surgery is currently the only effective treatment for obesity, there are several barriers&#xD;
        associated with it such as eligibility requirements, invasiveness, difficult recovery, and&#xD;
        cost making it not readily available for everyone. Some approved medications that help with&#xD;
        obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted&#xD;
        by providers or patients due to their limited responses and adverse side effects. Probiotic&#xD;
        cocktails have shown to be safe with little to no side effects. Preclinical models of&#xD;
        probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic&#xD;
        that is able to show significant weight loss along with lifestyle modifications would be&#xD;
        highly adopted and desirable.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Differences in metabolite concentrations pre &amp; post intervention - Stool</measure>
      <time_frame>Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).</time_frame>
      <description>Measurement of metabolomics via stool specimen.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in metabolite concentrations pre &amp; post intervention - Blood</measure>
      <time_frame>Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).</time_frame>
      <description>Measurement of metabolomics via blood specimen.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in microbiome levels pre &amp; post intervention - Stool</measure>
      <time_frame>Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).</time_frame>
      <description>16S RNA sequencing to measure microbiome levels via stool specimen.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in microbiome levels pre &amp; post intervention - Blood</measure>
      <time_frame>Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).</time_frame>
      <description>16S RNA sequencing to measure microbiome levels via blood specimen.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in microbiome levels pre &amp; post intervention - Stool</measure>
      <time_frame>Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).</time_frame>
      <description>Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in microbiome levels pre &amp; post intervention - Blood</measure>
      <time_frame>Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).</time_frame>
      <description>Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Differences in Subjective Stress Response - PANAS</measure>
      <time_frame>Lasting approximately 10 minutes, measured pre &amp; post the laboratory stress tasks, at baseline (week 0) and end of study (week 12).</time_frame>
      <description>Between and within group differences on the negative affect subscale from the Brief Positive Affect and Negative Affect Scale (PANAS) before and after the laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Autonomic Measures - Heart Rate Variability</measure>
      <time_frame>Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visits, lasting approximately 1 hour.</time_frame>
      <description>Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Autonomic Measures - Skin Conductance</measure>
      <time_frame>Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.</time_frame>
      <description>Between and within group differences in overall average change in skin conductance response (SCR) pre and post each laboratory stress task measured using BIOPAC GSR (galvanized skin response) 100C system. Measured in Hz.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in Autonomic Measures - Diastolic &amp; Systolic blood pressure</measure>
      <time_frame>Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.</time_frame>
      <description>Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in Attention/Executive Function - Color Stroop</measure>
      <time_frame>Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).</time_frame>
      <description>Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in Attention/Executive Function - Trails A &amp; B</measure>
      <time_frame>Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).</time_frame>
      <description>Between and within group differences on the time it takes to complete the Trails A &amp; B attention/executive function lab stress task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in Emotional Arousal System - IAPS task</measure>
      <time_frame>Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12).</time_frame>
      <description>Between and within group differences in valence and emotional arousal ratings during the International Affective Picture System (IAPS) task.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systolic and Diastolic Blood Pressure</measure>
      <time_frame>Measured three times, once at each in-clinic appointment (week 0, week 6, week 12).</time_frame>
      <description>Measurement of the pressure of circulating blood at rest</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometrics - BMI</measure>
      <time_frame>Measured three times, once at each in-clinic appointment (week 0, week 6, &amp; week 12)</time_frame>
      <description>Measurement of height(in) &amp; weight(lbs), used to calculate body mass index (BMI).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire Data - Diet</measure>
      <time_frame>Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement.</time_frame>
      <description>Use of validated surveys including the Food Frequency questionnaire, Food Choice Questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Questionnaire Data</measure>
      <time_frame>Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement.</time_frame>
      <description>Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometrics - waist and hip circumference</measure>
      <time_frame>Measured three times, once at each in-clinic appointment (week 0, week 6, &amp; week 12)</time_frame>
      <description>Measurement of waist and hip circumference (cm).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Differences in Multimodal Brain Signatures</measure>
      <time_frame>Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours.</time_frame>
      <description>Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Obesity</condition>
    <condition>Food Addiction</condition>
    <arm_group>
      <arm_group_label>Probiotic</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic</intervention_name>
      <description>Dietary Supplement taken once daily for 3 months (90 days).</description>
      <arm_group_label>Probiotic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Dietary Supplement taken once daily for 3 months (90days).</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 18-50&#xD;
  &#xD;
            -  BMI 25-40&#xD;
  &#xD;
            -  Male and Female&#xD;
  &#xD;
            -  Not Pregnant or Nursing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Co-morbidities including but not limited to:&#xD;
  &#xD;
            -  Type 1 (insulin dependent) diabetes&#xD;
  &#xD;
            -  vascular disease&#xD;
  &#xD;
            -  drastic weight loss (more than 10lbs over the preceding 2months)&#xD;
  &#xD;
            -  frequent strenuous exercise (i.e. marathon runners/heavy weight lifting)&#xD;
  &#xD;
            -  abdominal surgeries including weight loss surgery or partial/complete resection of&#xD;
               stomach or bowel&#xD;
  &#xD;
            -  untreated thyroid disease&#xD;
  &#xD;
            -  neurological disease&#xD;
  &#xD;
            -  Major medical condition the PI/MD feels would put the subject at risk or interfere&#xD;
               with data collection.&#xD;
  &#xD;
            -  Chronic pain&#xD;
  &#xD;
            -  Diagnosed DSM IV active psychiatric illness including eating disorders. Must not be&#xD;
               active or present for at least 2 years. Participants with a positive endorsement on&#xD;
               the MINI+ will be excluded.&#xD;
  &#xD;
            -  Using medications known to affect hunger/satiety/appetite&#xD;
  &#xD;
            -  Pregnant, lactating, postpartum less than 6months.&#xD;
  &#xD;
            -  Women of childbearing potential who are not practicing birth control or are planning&#xD;
               to get pregnant during the study.&#xD;
  &#xD;
            -  Use of oral/IV antibiotics within the last 3 months&#xD;
  &#xD;
            -  Use of probiotics in the last 3 months.&#xD;
  &#xD;
            -  Heavy use of alcohol and drugs will be determined by a positive endorsement on the&#xD;
               MINI+. If the MINI+ is positive for alcohol or drug dependence or abuse, the&#xD;
               participant will be excluded. In regards to tobacco use, participants will be excluded&#xD;
               if they smoke more than 1/2 pack per day.&#xD;
  &#xD;
            -  Cannabis use will not be exclusionary. If the MINI+ is positive for drug dependence or&#xD;
               abuse, the participant will be excluded.&#xD;
  &#xD;
            -  Significant change in usual diet and/or weight loss of more than 10lbs in the last 2&#xD;
               months.&#xD;
  &#xD;
            -  Anyone taking medicines on the medication exclusion list.&#xD;
  &#xD;
            -  Non-English Speakers (due to the use of validated questionnaires and limited&#xD;
               availability of translated copies, participants must be fluent in English so that they&#xD;
               will be able to read and follow directions easily.&#xD;
  &#xD;
            -  Maintenance pharmacotherapies will not be exclusionary so long as they have been on a&#xD;
               stable dose for 6months.&#xD;
  &#xD;
            -  Body weight at enrollment greater than 400lbs.&#xD;
  &#xD;
            -  Exclude from Optional MRI if: participant is unable to safely participate in the MRI&#xD;
               (claustrophobia, presence of devices affected by MRI such as pacemakers,&#xD;
               neurostimulators, metallic foreign bodies, etc.).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arpana Gupta, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Regents of the University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Tien Dong, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Regents of the University of California, Los Angeles</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Allison Vaughan, MPH</last_name>
      <phone>3108257206</phone>
      <email>GuptaLab@mednet.ucla.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90095</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Allison Vaughan, MPH</last_name>
        <phone>310-825-7206</phone>
        <email>GuptaLab@mednet.ucla.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
      <investigator_full_name>Arpana Gupta</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Probiotic</keyword>
    <keyword>Dietary Supplement</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Food Addiction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>At this time there is no plan to make the de-identified data available for sharing with other researchers.</ipd_description>
    </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/NCT06030362
  org study id: IRB 22-000796
  nct id: NCT06030362
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The current standard of care for obesity is the optimal management of comorbid conditions
        such as diabetes and hyperlipidemia, and counseling on diet, weight loss, or increased
        physical activity programs. However, lifestyle, diet, and behavioral interventions may
        provide between 7-10% reduction in initial weight and even fewer with long-term weight loss.
        In severely obese patients (BMI>40 or BMI>35 with comorbidities), bariatric surgery is also a
        potential treatment, but there is a high barrier for patients to undergo surgery for weight
        loss. These barriers include an aversion to major abdominal surgery, long recovery time,
        potential risk of vitamin deficiency, and risk for abdominal pain. For these reasons, there
        is a paramount need for other treatments for obesity and for food addiction.
  
        The current standard of care for obesity and food addiction is difficult to implement and
        lacks sustained efficacy. Most struggle to complete treatment, lose minimal weight, lack
        sustained weight loss, and engage in the well-known "YoYo" diet phenomenon. While bariatric
        surgery is currently the only effective treatment for obesity, there are several barriers
        associated with it such as eligibility requirements, invasiveness, difficult recovery, and
        cost making it not readily available for everyone. Some approved medications that help with
        obesity, such as orlistat, lorcaserin, or naltrexone-bupropion, have not been widely adopted
        by providers or patients due to their limited responses and adverse side effects. Probiotic
        cocktails have shown to be safe with little to no side effects. Preclinical models of
        probiotics demonstrate the ability to curb obesity in animal models. Therefore, a probiotic
        that is able to show significant weight loss along with lifestyle modifications would be
        highly adopted and desirable.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Differences in metabolite concentrations pre & post intervention - Stool
  time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
  description: Measurement of metabolomics via stool specimen.
  measure: Differences in metabolite concentrations pre & post intervention - Blood
  time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
  description: Measurement of metabolomics via blood specimen.
  measure: Differences in microbiome levels pre & post intervention - Stool
  time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
  description: 16S RNA sequencing to measure microbiome levels via stool specimen.
  measure: Differences in microbiome levels pre & post intervention - Blood
  time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
  description: 16S RNA sequencing to measure microbiome levels via blood specimen.
  measure: Differences in microbiome levels pre & post intervention - Stool
  time frame: Collected three times by the participant at home, once at baseline (week 0), once at mid-study (week 6), and once at the final 3month appointment (week 12).
  description: Shotgun metagenomics, sequencing to measure microbiome levels via stool specimen.
  measure: Differences in microbiome levels pre & post intervention - Blood
  time frame: Collected three times, once at baseline appointment (week 0), once at mid-study appointment (week 6), and once at the final 3month appointment (week 12).
  description: Shotgun metagenomics, sequencing to measure microbiome levels via blood specimen.
  measure: Differences in Subjective Stress Response - PANAS
  time frame: Lasting approximately 10 minutes, measured pre & post the laboratory stress tasks, at baseline (week 0) and end of study (week 12).
  description: Between and within group differences on the negative affect subscale from the Brief Positive Affect and Negative Affect Scale (PANAS) before and after the laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.
  measure: Changes in Autonomic Measures - Heart Rate Variability
  time frame: Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visits, lasting approximately 1 hour.
  description: Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.
  measure: Changes in Autonomic Measures - Skin Conductance
  time frame: Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
  description: Between and within group differences in overall average change in skin conductance response (SCR) pre and post each laboratory stress task measured using BIOPAC GSR (galvanized skin response) 100C system. Measured in Hz.
  measure: Changes in Autonomic Measures - Diastolic & Systolic blood pressure
  time frame: Measured throughout each laboratory stress task during the baseline (week 0) and end of study (week 12) visit. Lasting approximately 1 hour.
  description: Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.
  measure: Differences in Attention/Executive Function - Color Stroop
  time frame: Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
  description: Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.
  measure: Differences in Attention/Executive Function - Trails A & B
  time frame: Lasting approximately 10minutes, measured at baseline (week 0) and end of study (week 12).
  description: Between and within group differences on the time it takes to complete the Trails A & B attention/executive function lab stress task.
  measure: Differences in Emotional Arousal System - IAPS task
  time frame: Lasting approximately 15minutes, measured at baseline (week 0) and end of study (week 12).
  description: Between and within group differences in valence and emotional arousal ratings during the International Affective Picture System (IAPS) task.
  measure: Systolic and Diastolic Blood Pressure
  time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, week 12).
  description: Measurement of the pressure of circulating blood at rest
  measure: Anthropometrics - BMI
  time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
  description: Measurement of height(in) & weight(lbs), used to calculate body mass index (BMI).
  measure: Questionnaire Data - Diet
  time frame: Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement.
  description: Use of validated surveys including the Food Frequency questionnaire, Food Choice Questionnaire.
  measure: Questionnaire Data
  time frame: Self-Reported by the participant at home, collected 3 times (1) before beginning the dietary supplement, (2) at least 1 week before the mid-study appointment, and (3) within 1 week of finishing the 90-day dietary supplement.
  description: Use of validated surveys to assess ingestive behaviors, stress, health, physical activity, etc.
  measure: Anthropometrics - waist and hip circumference
  time frame: Measured three times, once at each in-clinic appointment (week 0, week 6, & week 12)
  description: Measurement of waist and hip circumference (cm).
  measure: Differences in Multimodal Brain Signatures
  time frame: Optional - Measured twice, once at baseline (week 0) and once at end of study (week 12) visit. Lasting approximately 1.5hours.
  description: Neuroimaging of a subset of participants brain via magnetic resonance imaging (MRI) procedure.
  arm group label: Probiotic
  arm group type: Active Comparator
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Dietary Supplement
  intervention name: Probiotic
  description: Dietary Supplement taken once daily for 3 months (90 days).
  arm group label: Probiotic
  intervention type: Dietary Supplement
  intervention name: Placebo
  description: Dietary Supplement taken once daily for 3 months (90days).
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Arpana Gupta, PhD
  role: Principal Investigator
  affiliation: The Regents of the University of California, Los Angeles
  last name: Tien Dong, MD, PhD
  role: Principal Investigator
  affiliation: The Regents of the University of California, Los Angeles
  last name: Allison Vaughan, MPH
  phone: 3108257206
  email: GuptaLab@mednet.ucla.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Los Angeles
  investigator full name: Arpana Gupta
  investigator title: Principal Investigator
  mesh term: Obesity
  mesh term: Food Addiction
  sharing ipd: No
  ipd description: At this time there is no plan to make the de-identified data available for sharing with other researchers.