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Emotion-Diet Interactions in Pregnancy (PREDIP)

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ClinicalTrials.gov Identifier: NCT04430439
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Karen Lindsay, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE June 10, 2020
First Posted Date  ICMJE June 12, 2020
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE May 11, 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2021)
Postprandial glycemic response [ Time Frame: 2 weeks ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
Postprandial glucose/insulin response [ Time Frame: 2 weeks ]
Intra-individual glycemic response (area-under-the-curve of glucose/insulin ratio) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2020)
  • Postprandial lipid response [ Time Frame: 2 weeks ]
    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
  • Postprandial inflammatory response [ Time Frame: 2 weeks ]
    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
  • Postprandial metabolic response to stress by meal type [ Time Frame: 3 hours ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotion-Diet Interactions in Pregnancy
Official Title  ICMJE Postprandial Response to Emotion-Diet Interactions in Pregnancy
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pregnancy Related
  • Stress, Psychological
  • Glucose Intolerance During Pregnancy
  • Emotional Stress
  • Postprandial Hyperglycemia
  • Insulin Sensitivity/Resistance
Intervention  ICMJE
  • Behavioral: Psychosocial stress
    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.
  • Behavioral: Control non-stress
    Participants will have a relaxed 15 minute conversation with a familiar research team member.
Study Arms  ICMJE
  • Experimental: Psychosocial stress
    Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
    Intervention: Behavioral: Psychosocial stress
  • Active Comparator: Control non-stress
    Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).
    Intervention: Behavioral: Control non-stress
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English and/or Spanish speaking
  • 18-22 week's gestation
  • Pre-pregnancy BMI 25.0-34.9 kg/m2
  • Singleton, intrauterine pregnancy
  • Non-smoker
  • Non-diabetic and normal result on a random peripheral blood glucose test at the screening visit (<200 mg/dl)

Exclusion Criteria:

  • Non-fluency in English or Spanish
  • BMI <25.0 or ≥35.0 kg/m2
  • >22 week's gestation
  • multiple pregnancy
  • current smoker
  • present/prior obstetric conditions (preeclampsia, infections, placental abnormalities, uterine anomalies, congenital malformations, fetal chromosomal abnormalities)
  • presence of any conditions that may dysregulate neuroendocrine, metabolic or cardiovascular function, such as diabetes, hepatic, renal, or autoimmune disorders
  • current psychiatric disorders or undergoing treatment/taking psychiatric medications
  • use of systemic/frequent corticosteroids or thyroid, lipid-lowering or anti-diabetic medications
  • gestational diabetes mellitus or raised glucose result detected on the screening visit
  • unwilling to eat the standard breakfast meal at each laboratory visit
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Karen Lindsay 949-824-0148 kllindsa@hs.uci.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04430439
Other Study ID Numbers  ICMJE UCI 2020-5914
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karen Lindsay, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Irvine
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP