Emotion-Diet Interactions in Pregnancy

NCT04430439 | Completed Results

• 2 other identifiers: 20205914R00HD096109
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 2

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).

Conditions

Pregnancy Related; Stress, Psychological; Glucose Intolerance During Pregnancy; Emotional Stress; Postprandial Hyperglycemia; Insulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (2)

• Postprandial Glycemic Response With Stress Exposure

  Glycemic response (area-under-the-curve of glucose) to the assigned meal type during the visit with the psychosocial stress task (TSST)

  2 weeks

• Postprandial Glycemic Response Without Stress Exposure

  Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition

  2 weeks

Secondary Outcomes (2)

• Postprandial Insulin Response With Stress Exposure

  2 weeks

• Postprandial Insulin Response Without Stress Exposure

  2 weeks

Study Arms (2)

Psychosocial stress

EXPERIMENTAL

Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).

Behavioral: Psychosocial stress

Control non-stress

ACTIVE COMPARATOR

Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Behavioral: Control non-stress

Interventions

Psychosocial stress BEHAVIORAL

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.

Psychosocial stress

Control non-stress BEHAVIORAL

Participants will have a relaxed 15 minute conversation with a familiar research team member.

Control non-stress

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English and/or Spanish speaking
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of California, Irvine

Irvine, California, 92617, United States

Location

UCI Medical Center, University of California, Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Hyperglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Limitations and Caveats

Could not obtain an assay to test free fatty acids from plasma samples so we were unable to fulfill the aim of assessing the impact of stress exposure on postprandial fatty acid response to the meals.

Results Point of Contact

• Title: Karen Lindsay
• Organization: University of California, Irvine

kllindsa@hs.uci.edu

949-824-0148

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: May 11, 2021
• Primary Completion: February 14, 2024
• Study Completion: February 28, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)