<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/NCT04430439</url>
  </required_header>
  <id_info>
    <org_study_id>UCI 2020-5914</org_study_id>
    <nct_id>NCT04430439</nct_id>
  </id_info>
  <brief_title>Emotion-Diet Interactions in Pregnancy</brief_title>
  <acronym>PREDIP</acronym>
  <official_title>Postprandial Response to Emotion-Diet Interactions in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</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 will investigate how maternal emotional state following a controlled stress&#xD;
      exposure in pregnancy influences blood glucose and insulin levels after eating a standardized&#xD;
      meal, and whether the effects of emotional state on blood glucose and insulin is different&#xD;
      after eating a healthy meal (low GI) compared to a less healthy meal (high GI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Maternal glucose-insulin homeostasis in pregnancy represents one of the most important&#xD;
      physiological processes for maternal and child health outcomes. Although maternal diet is a&#xD;
      key regulator of this process, its effects vary widely across individuals. Maternal stress&#xD;
      could represent a moderator of considerable importance in this regard, yet little is known&#xD;
      about the effects of stress on glycemic control in pregnancy and whether the effects of&#xD;
      stress may vary as a function of diet quality. This project will investigate the effects of&#xD;
      acute psychosocial stress exposure on the postprandial metabolic response to a meal of&#xD;
      varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 11, 2021</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">November 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>Participants will be first randomized in a parallel design to meal type (low vs high GI). Within the meal arms, participants will be randomized in a cross-over design to undergo the lab-based stress and non-stress tasks.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial glycemic response</measure>
    <time_frame>2 weeks</time_frame>
    <description>Intra-individual glycemic response (area-under-the-curve of glucose) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial lipid response</measure>
    <time_frame>2 weeks</time_frame>
    <description>Intra-individual lipid response (area-under-the-curve of triglycerides and free fatty acids) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial inflammatory response</measure>
    <time_frame>2 weeks</time_frame>
    <description>Intra-individual lipid response (area-under-the-curve of inflammatory cytokines) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial metabolic response to stress by meal type</measure>
    <time_frame>3 hours</time_frame>
    <description>Inter-individual difference in the glycemic/lipid/inflammatory AUC in response to the TSST between participants consuming the low GI compared to the high GI meal type</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Stress, Psychological</condition>
  <condition>Glucose Intolerance During Pregnancy</condition>
  <condition>Emotional Stress</condition>
  <condition>Postprandial Hyperglycemia</condition>
  <condition>Insulin Sensitivity/Resistance</condition>
  <arm_group>
    <arm_group_label>Psychosocial stress</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control non-stress</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial stress</intervention_name>
    <description>The TSST is a 15 minute standardized lab-based challenge task that involves speech preparation, speech delivery while being evaluated by strangers and video taped, and complex mental arithmetic with critiques if errors are made.</description>
    <arm_group_label>Psychosocial stress</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control non-stress</intervention_name>
    <description>Participants will have a relaxed 15 minute conversation with a familiar research team member.</description>
    <arm_group_label>Control non-stress</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English and/or Spanish speaking&#xD;
&#xD;
          -  18-22 week's gestation&#xD;
&#xD;
          -  Pre-pregnancy BMI 25.0-39.9 kg/m2&#xD;
&#xD;
          -  Singleton, intrauterine pregnancy&#xD;
&#xD;
          -  Non-smoker&#xD;
&#xD;
          -  Non-diabetic and normal result on a random peripheral blood glucose test at the&#xD;
             screening visit (&lt;200 mg/dl)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-fluency in English or Spanish&#xD;
&#xD;
          -  BMI &lt;25.0 or ≥40.0 kg/m2&#xD;
&#xD;
          -  &gt;22 week's gestation&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  current smoker&#xD;
&#xD;
          -  present/prior obstetric conditions (preeclampsia, infections, placental abnormalities,&#xD;
             uterine anomalies, congenital malformations, fetal chromosomal abnormalities)&#xD;
&#xD;
          -  presence of any conditions that may dysregulate neuroendocrine, metabolic or&#xD;
             cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders&#xD;
&#xD;
          -  current psychiatric disorders or undergoing treatment/taking psychiatric medications&#xD;
&#xD;
          -  use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic&#xD;
             medications&#xD;
&#xD;
          -  gestational diabetes mellitus or raised glucose result detected on the screening visit&#xD;
&#xD;
          -  unwilling to eat the standard breakfast meal at each laboratory visit&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Karen Lindsay</last_name>
    <phone>949-824-0148</phone>
    <email>kllindsa@hs.uci.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of California, Irvine</name>
      <address>
        <city>Irvine</city>
        <state>California</state>
        <zip>92617</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Lindsay</last_name>
      <phone>949-824-0148</phone>
      <email>kllindsa@hs.uci.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCI Medical Center, University of California, Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Karen Lindsay, PhD</last_name>
      <phone>949-824-0148</phone>
      <email>kllindsa@uci.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Karen Lindsay</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Resistance</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04430439
org study id: UCI 2020-5914
nct id: NCT04430439
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will investigate how maternal emotional state following a controlled stress
      exposure in pregnancy influences blood glucose and insulin levels after eating a standardized
      meal, and whether the effects of emotional state on blood glucose and insulin is different
      after eating a healthy meal (low GI) compared to a less healthy meal (high GI).
Maternal glucose-insulin homeostasis in pregnancy represents one of the most important
      physiological processes for maternal and child health outcomes. Although maternal diet is a
      key regulator of this process, its effects vary widely across individuals. Maternal stress
      could represent a moderator of considerable importance in this regard, yet little is known
      about the effects of stress on glycemic control in pregnancy and whether the effects of
      stress may vary as a function of diet quality. This project will investigate the effects of
      acute psychosocial stress exposure on the postprandial metabolic response to a meal of
      varying glycemic index (GI) among women with overweight/obesity in mid-pregnancy.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants will be first randomized in a parallel design to meal type (low vs high GI). Within the meal arms, participants will be randomized in a cross-over design to undergo the lab-based stress and non-stress tasks.
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Postprandial glycemic response
time frame: 2 weeks
description: Intra-individual glycemic response (area-under-the-curve of glucose) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task
measure: Postprandial lipid response
time frame: 2 weeks
description: Intra-individual lipid response (area-under-the-curve of triglycerides and free fatty acids) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task
measure: Postprandial inflammatory response
time frame: 2 weeks
description: Intra-individual lipid response (area-under-the-curve of inflammatory cytokines) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task
measure: Postprandial metabolic response to stress by meal type
time frame: 3 hours
description: Inter-individual difference in the glycemic/lipid/inflammatory AUC in response to the TSST between participants consuming the low GI compared to the high GI meal type
arm group label: Psychosocial stress
arm group type: Experimental
description: Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
arm group label: Control non-stress
arm group type: Active Comparator
description: Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).
intervention type: Behavioral
intervention name: Psychosocial stress
description: The TSST is a 15 minute standardized lab-based challenge task that involves speech preparation, speech delivery while being evaluated by strangers and video taped, and complex mental arithmetic with critiques if errors are made.
arm group label: Psychosocial stress
intervention type: Behavioral
intervention name: Control non-stress
description: Participants will have a relaxed 15 minute conversation with a familiar research team member.
arm group label: Control non-stress
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Karen Lindsay
phone: 949-824-0148
email: kllindsa@hs.uci.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Karen Lindsay
investigator title: Assistant Professor
mesh term: Insulin Resistance
mesh term: Hyperglycemia
mesh term: Glucose Intolerance
mesh term: Stress, Psychological
sharing ipd: No