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Clinical Trials/NCT04430439
NCT04430439
Completed
Not Applicable

Postprandial Response to Emotion-Diet Interactions in Pregnancy

University of California, Irvine2 sites in 1 country113 target enrollmentMay 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
University of California, Irvine
Enrollment
113
Locations
2
Primary Endpoint
Postprandial Glycemic Response With Stress Exposure
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2021
End Date
February 28, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Lindsay

Assistant Professor

University of California, Irvine

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 (\<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

Outcomes

Primary Outcomes

Postprandial Glycemic Response With Stress Exposure

Time Frame: 2 weeks

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

Postprandial Glycemic Response Without Stress Exposure

Time Frame: 2 weeks

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

Secondary Outcomes

  • Postprandial Insulin Response With Stress Exposure(2 weeks)
  • Postprandial Insulin Response Without Stress Exposure(2 weeks)

Study Sites (2)

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