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
University of California, Irvine
Information provided by (Responsible Party):
University of California, Irvine
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|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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 :
- 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 :
- 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
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