N/A
N=113
Emotion-Diet Interactions in Pregnancy
Pregnancy Related · Stress, Psychological · Glucose Intolerance During Pregnancy · Emotional Stress · Postprandial Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT04430439 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Postprandial Glycemic Response With Stress Exposure — 12998.83; 12833.69 mg/dl * minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychosocial stress (Behavioral); Control non-stress (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Irvine
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postprandial Glycemic Response With Stress Exposure |
12998.83; 12833.69 | — |
| PRIMARY Postprandial Glycemic Response Without Stress Exposure |
12754.18; 13099.27 | — |
| SECONDARY Postprandial Insulin Response With Stress Exposure |
7142.74; 10782.48 | — |
| SECONDARY Postprandial Insulin Response Without Stress Exposure |
6791.51; 11027.89 | — |
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).
Eligibility Criteria
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 ( 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
Data sourced from ClinicalTrials.gov (NCT04430439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.