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/NCT06035718</url>
    </required_header>
    <id_info>
      <org_study_id>Overweight</org_study_id>
      <nct_id>NCT06035718</nct_id>
    </id_info>
    <brief_title>Effect of Transcranial Direct Current Stimulation (tDCS) and Probiotic Supplementation in Overweight Adults</brief_title>
    <official_title>Comparing the Effectiveness of Transcranial Direct Stimulation (tDCS) and Probiotic Supplementation on Risky Decision-making, Impulsivity, Self-control, and Food Selection in Overweight Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Tehran</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Messina</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tabriz University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Tehran</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 aim of the current study is to investigate and compare the effectiveness of probiotic&#xD;
        supplementation and tDCS stimulation on risky decision-making related to food choices in&#xD;
        overweight people. Considering the relatively established communication and interaction&#xD;
        between the gut-brain-microbiome axis, the investigators expect that transcranial direct&#xD;
        current stimulation and probiotic supplementation can both improve decision-making (decrease&#xD;
        risky and impulsive decisions) and increase self-control in overweight people.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">September 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Body analysis test</measure>
      <time_frame>Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.</time_frame>
      <description>This is a technique to determine the percentage of body mass that is fat compared to muscle. It can also indicate where the fat and muscle are carried within the body.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)</measure>
      <time_frame>Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.</time_frame>
      <description>This is a self-report tool that assesses five subscales (urgency, premeditation, perseverance, sensation seeking, and positive urgency) that are used to measure five distinct dimensions of impulsive behavior; each scale ranging from 4 to 16); Higher scores represent worse outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Eating attitudes Test (EAT-26)</measure>
      <time_frame>Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.</time_frame>
      <description>This tool is used to identify the presence of &quot;eating disorder risk&quot; based on attitudes, feelings and behaviours related to eating. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Balloon analogue risk task (BART)</measure>
      <time_frame>Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.</time_frame>
      <description>BART is a computerized decision-making task that is used to assess risk-taking behavior. The BART simulates a real-world situation, involving actual risky behavior, where taking a risk up until a certain point yields a reward.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tangney self-control questionnaire (Form 36)</measure>
      <time_frame>Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.</time_frame>
      <description>This is a self-report measurement to assess individual differences in traits of self-control. Scores range from 0 to 144 with higher scores representing worse outcome.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Overweight and Obesity</condition>
    <arm_group>
      <arm_group_label>Active tDCS over the dorsolateral prefrontal cortex (DLPFC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active tDCS over the ventromedial prefrontal cortex (VMPFC)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham tDCS Stimulation</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>In this group, participants will receive sham tDCS which will ramp up for 30 s at the beginning of the session and then ramp down and be switched off during the 20-minute stimulation session.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probiotic supplementation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Probiotic Blend Capsule</intervention_name>
      <description>By a probiotic blend capsule a specific product is intended which contains the following: Lactobacillus rhamnosus Lactobacillus plantarum Lactobacillus casei Lactobacillus helveticus Lactobacillus acidophilus Lactobacillus bulgaricus Lactobacillus gasseri Bifidobacterium bifidum Bifidobacterium lactis Bifidobacterium breve Bifidobacterium longum Streptococcus thermophile Fructooligosaccharides (FOS).</description>
      <arm_group_label>Probiotic supplementation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>tDCS</intervention_name>
      <description>Using a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp.</description>
      <arm_group_label>Active tDCS over the dorsolateral prefrontal cortex (DLPFC)</arm_group_label>
      <arm_group_label>Active tDCS over the ventromedial prefrontal cortex (VMPFC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham tDCS</intervention_name>
      <description>Using a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp. At this arm the electric current will be applied for a very short time (30 s) after which the device will turn off, thus providing the initial tingling sensation over the scalp but not interfering with the ongoing brain activity.</description>
      <arm_group_label>Sham tDCS Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  BMI over 25&#xD;
  &#xD;
            -  Higher than normal fat level&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Breastfeeding&#xD;
  &#xD;
            -  Smoking more than 10 cigarettes a day&#xD;
  &#xD;
            -  Excessive consumption of alcohol&#xD;
  &#xD;
            -  Suffering from chronic cardiovascular and kidney diseases&#xD;
  &#xD;
            -  Chronic digestive diseases such as celiac disease,&#xD;
  &#xD;
            -  Chronic inflammatory bowel diseases such as colitis, intestinal surgery, cancer, etc.&#xD;
  &#xD;
            -  Suffering from acute and chronic diarrhea in the last one month&#xD;
  &#xD;
            -  Taking antibiotics in two months before the start of the study,&#xD;
  &#xD;
            -  Continuous use of prebiotic and probiotic products and drugs in one month before the&#xD;
               start of the intervention&#xD;
  &#xD;
            -  Frequent use of antibiotics during the last month before the start of the intervention&#xD;
  &#xD;
            -  Taking weight loss medications and following a special slimming diet in the last 3&#xD;
               months before the intervention.&#xD;
  &#xD;
            -  History of epilepsy and seizures, stroke,&#xD;
  &#xD;
            -  Use of pacemaker&#xD;
  &#xD;
            -  Presence of metal implanted in the scalp or brain,&#xD;
  &#xD;
            -  Presence of skin lesions at the tDCS stimulation site, and history of head injury or&#xD;
               brain surgery.&#xD;
  &#xD;
            -  Brain disorders and long-term and chronic use of neuropsychiatric drugs.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marzieh Heysiattalab, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Tabriz</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Reza Kazemi, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Tehran</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sara Derafsheh, MSC</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Tabriz</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abed Hadipour Lakmehsari, PhD</last_name>
      <phone>3883041384</phone>
      <phone_ext>+39</phone_ext>
      <email>ahadipourlakmehsari@unime.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Atieh neuroscience center</name>
        <address>
          <city>Tehran</city>
          <zip>1969713663</zip>
          <country>Iran, Islamic Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Reza Kazemi, PHD</last_name>
        <phone>009802184012121</phone>
        <email>rezakazemi@ut.ac.ir</email>
      </contact>
      <investigator>
        <last_name>Sara Derafsheh, MSC</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Iran, Islamic Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Tehran</investigator_affiliation>
      <investigator_full_name>reza kazemi</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <keyword>transcranial direct current stimulation</keyword>
    <keyword>obesity</keyword>
    <keyword>overweight</keyword>
    <keyword>impulse control</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Overweight</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06035718
  org study id: Overweight
  nct id: NCT06035718
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the current study is to investigate and compare the effectiveness of probiotic
        supplementation and tDCS stimulation on risky decision-making related to food choices in
        overweight people. Considering the relatively established communication and interaction
        between the gut-brain-microbiome axis, the investigators expect that transcranial direct
        current stimulation and probiotic supplementation can both improve decision-making (decrease
        risky and impulsive decisions) and increase self-control in overweight people.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Body analysis test
  time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
  description: This is a technique to determine the percentage of body mass that is fat compared to muscle. It can also indicate where the fat and muscle are carried within the body.
  measure: Impulsive Behavior Scale Questionnaire measuring Urgency, Premeditation (lack of), Perseverance (lack of), and Sensation seeking (UPPS)
  time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
  description: This is a self-report tool that assesses five subscales (urgency, premeditation, perseverance, sensation seeking, and positive urgency) that are used to measure five distinct dimensions of impulsive behavior; each scale ranging from 4 to 16); Higher scores represent worse outcome.
  measure: Eating attitudes Test (EAT-26)
  time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
  description: This tool is used to identify the presence of "eating disorder risk" based on attitudes, feelings and behaviours related to eating. The total score (between 0 and 78) provides an overall risk score, where higher scores indicating greater risk of an eating disorder.
  measure: Balloon analogue risk task (BART)
  time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
  description: BART is a computerized decision-making task that is used to assess risk-taking behavior. The BART simulates a real-world situation, involving actual risky behavior, where taking a risk up until a certain point yields a reward.
  measure: Tangney self-control questionnaire (Form 36)
  time frame: Depending on the experimental group: 10 stimulation days in tDCS groups and 30 days in the probiotic group.
  description: This is a self-report measurement to assess individual differences in traits of self-control. Scores range from 0 to 144 with higher scores representing worse outcome.
  arm group label: Active tDCS over the dorsolateral prefrontal cortex (DLPFC)
  arm group type: Experimental
  description: In this group, participants will receive active 2 milliampere (mA) tdcs over the DLPFC (anode on F3 and cathode onF4) for 20 minutes.
  arm group label: Active tDCS over the ventromedial prefrontal cortex (VMPFC)
  arm group type: Active Comparator
  description: In this group, participants will receive active 2 mA tdcs over the VMPFC (anode on Fpz and cathode on Cz) for 20 minutes.
  arm group label: Sham tDCS Stimulation
  arm group type: Sham Comparator
  description: In this group, participants will receive sham tDCS which will ramp up for 30 s at the beginning of the session and then ramp down and be switched off during the 20-minute stimulation session.
  arm group label: Probiotic supplementation
  arm group type: Active Comparator
  description: In this group, participants will consume 2 probiotic supplements (The synbiotics family) daily, for one month.
  intervention type: Drug
  intervention name: Probiotic Blend Capsule
  description: By a probiotic blend capsule a specific product is intended which contains the following: Lactobacillus rhamnosus Lactobacillus plantarum Lactobacillus casei Lactobacillus helveticus Lactobacillus acidophilus Lactobacillus bulgaricus Lactobacillus gasseri Bifidobacterium bifidum Bifidobacterium lactis Bifidobacterium breve Bifidobacterium longum Streptococcus thermophile Fructooligosaccharides (FOS).
  arm group label: Probiotic supplementation
  intervention type: Device
  intervention name: tDCS
  description: Using a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp.
  arm group label: Active tDCS over the dorsolateral prefrontal cortex (DLPFC)
  arm group label: Active tDCS over the ventromedial prefrontal cortex (VMPFC)
  intervention type: Device
  intervention name: Sham tDCS
  description: Using a tDCS device, a mild direct electric current is going to be non-invasively administered to the brain using rubber electrodes placed over the scalp. At this arm the electric current will be applied for a very short time (30 s) after which the device will turn off, thus providing the initial tingling sensation over the scalp but not interfering with the ongoing brain activity.
  arm group label: Sham tDCS Stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marzieh Heysiattalab, PhD
  role: Study Director
  affiliation: University of Tabriz
  last name: Reza Kazemi, PhD
  role: Study Director
  affiliation: University of Tehran
  last name: Sara Derafsheh, MSC
  role: Principal Investigator
  affiliation: University of Tabriz
  last name: Abed Hadipour Lakmehsari, PhD
  phone: 3883041384
  phone ext: +39
  email: ahadipourlakmehsari@unime.it
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Iran, Islamic Republic of
  responsible party type: Principal Investigator
  investigator affiliation: University of Tehran
  investigator full name: reza kazemi
  investigator title: Assistant professor
  mesh term: Overweight
  sharing ipd: No