Clinical trial NCT04430439: Emotion-Diet Interactions in Pregnancy
Official title: Postprandial Response to Emotion-Diet Interactions in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Stress, Psychological
Glucose Intolerance During Pregnancy
Emotional Stress
Postprandial Hyperglycemia
Insulin Sensitivity/Resistance
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

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
* unwilling to eat the standard breakfast meal at each laboratory visit

Primary outcomes:
measure: Postprandial glycemic response
timeFrame: 2 weeks
Secondary outcomes:
measure: Postprandial lipid response
timeFrame: 2 weeks
measure: Postprandial inflammatory response
timeFrame: 2 weeks
measure: Postprandial metabolic response to stress by meal type
timeFrame: 3 hours
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Orange
country: United States
facility: UCI Medical Center, University of California, Irvine
state: California
Study officials:
References: