Emotion-Diet Interactions in Pregnancy

Not Applicable

Completed

• Conditions: Emotional Stress; Stress, Psychological; Glucose Intolerance During Pregnancy; Insulin Sensitivity/Resistance; Pregnancy Related; Postprandial Hyperglycemia
• Interventions: Behavioral: Psychosocial stress; Behavioral: Control non-stress

• Registration Number: NCT04430439
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2021-05-11
• Primary Completion: 2024-02-14
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

Inclusion Criteria

• English and/or Spanish speaking
• 18-22 week's gestation
• Pre-pregnancy BMI 25.0-39.9 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 ≥40.0 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Psychosocial stress	Psychosocial stress	Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
Control non-stress	Control non-stress	Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Primary Outcome Measures

Name	Time	Method
Postprandial glycemic response	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

Name	Time	Method
Postprandial lipid response	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	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	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

Trial Locations

Locations (2)

UCI Medical Center, University of California, Irvine; 🇺🇸 Orange, California, United States

University of California, Irvine; 🇺🇸 Irvine, California, United States