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Clinical Trials/NCT03278392
NCT03278392
Completed
Not Applicable

Prenatal Emotion-Diet Interactions and the Metabolic Response

University of California, Irvine1 site in 1 country38 target enrollmentNovember 17, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
University of California, Irvine
Enrollment
38
Locations
1
Primary Endpoint
Difference in the glycemic response to the standardized meal +/- psychosocial challenge task
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study seeks to understand how a mother's emotional state in pregnancy influences her biological response to food intake.

Detailed Description

The purpose of this research study is to understand how a mother's emotional state in pregnancy influences her biological response to food intake. Natural variation in emotional and mental state is frequently experienced in daily life, including during pregnancy. While the investigators understand that a healthy diet is important in pregnancy for maintaining blood sugar levels and other metabolic factors within normal ranges for optimal development of the baby, less consideration is given to the health effects of a mother's mental state during pregnancy. It may even be possible that, regardless of what a woman eats or drinks, the way her body responds to food may differ according to her emotional or mental state. This research is particularly interested in understanding how the combination of maternal emotional state and diet influence metabolism in pregnancy. Thus, the aim of this study is to test whether and how an individual's emotional response to a mental challenge of varying complexity during pregnancy modifies the body's metabolic response to a standard breakfast.

Registry
clinicaltrials.gov
Start Date
November 17, 2017
End Date
May 10, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Lindsay

Principal Investigator

University of California, Irvine

Eligibility Criteria

Inclusion Criteria

  • Age 18-40 years
  • Hispanic ethnicity
  • English and/or Spanish speaking
  • Multiparous
  • 28-30 week's gestation
  • Pre-pregnancy BMI 25.0-34.9 kg/m2
  • Singleton, intrauterine pregnancy
  • Non-smoker
  • Non-diabetic and negative result on routine prenatal glucose challenge test (GCT)

Exclusion Criteria

  • BMI \<25.0 or ≥35.0 kg/m2
  • \>30 week's gestation
  • multiple pregnancy
  • nulliparous
  • present/prior obstetric risk conditions (hypertension, preeclampsia, infections, placental abnormalities)
  • current smoker
  • current psychiatric disorders or undergoing treatment/taking psychiatric medications
  • Use of systemic/frequent corticosteroids or thyroid meds
  • Diabetic or presence of other metabolic or neuroendocrine disorders

Outcomes

Primary Outcomes

Difference in the glycemic response to the standardized meal +/- psychosocial challenge task

Time Frame: 2 hours

Glycemic response (area-under-the-curve of glucose) to the standardized breakfast drink following exposure to either the psychosocial challenge (TSST) or non-challenge (placebo-TSST) task.

Secondary Outcomes

  • Difference in the triglyceride response to the standardized meal +/- psychosocial challenge task(2 hours)
  • Physiological stress response to the psychosocial challenge task(2 hours)

Study Sites (1)

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