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Emotion-Diet Interactions in Pregnancy (PREDIP)

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ClinicalTrials.gov Identifier: NCT04430439
Recruitment Status : Not yet recruiting
First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
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
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : June 2023

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 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


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



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

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
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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04430439    
Other Study ID Numbers: UCI 2020-5914
First Posted: June 12, 2020    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
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
Hyperglycemia
Glucose Intolerance
Stress, Psychological
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Behavioral Symptoms