Emotional Stress, Glucose Intolerance During Pregnancy, Insulin Sensitivity/Resistance, Postprandial Hyperglycemia, Pregnancy Related, Stress, Psychological
Conditions
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.
Interventions
BEHAVIORALPsychosocial stress
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.
BEHAVIORALControl non-stress
Participants will have a relaxed 15 minute conversation with a familiar research team member.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Glycemic Response With Stress Exposure | 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 | 2 weeks | Glycemic response (glucose area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial Insulin Response Without Stress Exposure | 2 weeks | Insulin response (area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition |
| Postprandial Insulin Response With Stress Exposure | 2 weeks | Insulin response (area-under-the-curve) to the assigned meal type during the visit with the standardized stress task |
Countries
United States
Participant flow
Recruitment details
Participants were recruited between May 2021 and February 2024, primarily from prenatal clinics affiliated with the UCI medical center. Some participants from non-UCI clinics were recruited by circulating study flyers by university-wide email and sharing with local business/non-profit organizations.
Pre-assignment details
Upon confirmation of eligibility and completing the consent visit, participants were immediately assigned to the low or high GI meal groups and randomized to the order of their stress or non-stress lab visits.
Participants by arm
| Arm | Count |
|---|---|
| Low GI Meal Participants assigned to this group consumed a low glycemic index breakfast at both study visits (nutrition shake high in fiber with minimal added sugars). Blood and saliva samples were collected at baseline (fasting) immediately before consuming the meal, and then at 7 postprandial defined timepoints until 2.5 hours. | 57 |
| High GI Meal Participants assigned to this group consumed a high glycemic index breakfast at both study visits (nutrition shake high in added sugars plus a portion of apple sauce). Blood and saliva samples were collected at baseline (fasting) immediately before consuming the meal, and then at 7 postprandial defined timepoints until 2.5 hours. | 56 |
| Total | 113 |
Baseline characteristics
| Characteristic | Low GI Meal | High GI Meal | Total |
|---|---|---|---|
| Age, Continuous | 28.60 years STANDARD_DEVIATION 5.45 | 27.96 years STANDARD_DEVIATION 5.41 | 28.28 years STANDARD_DEVIATION 5.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 44 Participants | 48 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 8 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Pre-pregnancy body mass index (ppBMI) | 30.34 Kg/m^2 STANDARD_DEVIATION 4.06 | 30.86 Kg/m^2 STANDARD_DEVIATION 3.83 | 30.6 Kg/m^2 STANDARD_DEVIATION 3.94 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 9 Participants | 14 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 25 Participants | 23 Participants | 48 Participants |
| Race (NIH/OMB) White | 16 Participants | 19 Participants | 35 Participants |
| Sex: Female, Male Female | 57 Participants | 56 Participants | 113 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 113 |
| other Total, other adverse events | 0 / 113 |
| serious Total, serious adverse events | 0 / 113 |
Outcome results
Primary
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
Time frame: 2 weeks
Population: 15 participants only completed lab visit 1 and missed lab visit 2. Of those, 3 were assigned to undergo the non-stress task on visit 2 and thus are missing data for this analysis.~Some participants had insufficient blood sample collections at fasting or later timepoints, such that glucose values were missing and glucose AUC could not be computed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low GI Meal | Postprandial Glycemic Response Without Stress Exposure | 12754.18 mg/dl * minutes | Standard Deviation 3028.18 |
| High GI Meal | Postprandial Glycemic Response Without Stress Exposure | 13099.27 mg/dl * minutes | Standard Deviation 4038.88 |
Primary
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)
Time frame: 2 weeks
Population: 15 participants only completed the first lab visit and missed the second visit. Of those, 11 were assigned to undergo the stress task at visit 2 and thus are missing data for the present outcome.~Among those who did complete the visit with the stress task, some participants had insufficient blood sample collections at fasting or later timepoints, such that glucose values were missing and glucose AUC could not be computed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low GI Meal | Postprandial Glycemic Response With Stress Exposure | 12998.83 mg/dl * minutes | Standard Deviation 3507.22 |
| High GI Meal | Postprandial Glycemic Response With Stress Exposure | 12833.69 mg/dl * minutes | Standard Deviation 4643.66 |
Secondary
Postprandial Insulin Response Without Stress Exposure
Insulin response (area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition
Time frame: 2 weeks
Population: 15 participants only completed lab visit 1 and missed lab visit 2. Of those, 3 were assigned to undergo the non-stress task on visit 2 and thus are missing data for this analysis.~Some participants had insufficient blood sample collections at fasting or later timepoints, such that glucose values were missing and glucose AUC could not be computed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low GI Meal | Postprandial Insulin Response Without Stress Exposure | 6791.51 uU/ml * minutes | Standard Deviation 2865.53 |
| High GI Meal | Postprandial Insulin Response Without Stress Exposure | 11027.89 uU/ml * minutes | Standard Deviation 3437.65 |
Secondary
Postprandial Insulin Response With Stress Exposure
Insulin response (area-under-the-curve) to the assigned meal type during the visit with the standardized stress task
Time frame: 2 weeks
Population: 15 participants only completed the first lab visit and missed the second visit. Of those, 11 were assigned to undergo the stress task at visit 2 and thus are missing data for the present outcome.~Among those who did complete the visit with the stress task, some participants had insufficient blood sample collections at fasting or later timepoints, such that insulin values were missing and insulin AUC could not be computed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Low GI Meal | Postprandial Insulin Response With Stress Exposure | 7142.74 uU/ml * minutes | Standard Deviation 3329.37 |
| High GI Meal | Postprandial Insulin Response With Stress Exposure | 10782.48 uU/ml * minutes | Standard Deviation 3704.12 |