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Emotion-Diet Interactions in Pregnancy (PREDIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04430439
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : May 13, 2021
Information provided by (Responsible Party):
Karen Lindsay, University of California, Irvine

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).

Condition or disease Intervention/treatment Phase
Pregnancy Related Stress, Psychological Glucose Intolerance During Pregnancy Emotional Stress Postprandial Hyperglycemia Insulin Sensitivity/Resistance Behavioral: Psychosocial stress Behavioral: Control non-stress Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: Postprandial Response to Emotion-Diet Interactions in Pregnancy
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Experimental: Psychosocial stress
Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
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.

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).
Behavioral: Control non-stress
Participants will have a relaxed 15 minute conversation with a familiar research team member.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04430439

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Contact: Karen Lindsay 949-824-0148

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United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92617
Contact: Karen Lindsay    949-824-0148   
Sponsors and Collaborators
University of California, Irvine
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Responsible Party: Karen Lindsay, Assistant Professor, University of California, Irvine Identifier: NCT04430439    
Other Study ID Numbers: UCI 2020-5914
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Glucose Intolerance
Stress, Psychological
Glucose Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms