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| ID | Type | Description | Link |
|---|---|---|---|
| R00HD096109 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psychosocial stress | Experimental | Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI). |
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| Control non-stress | Active Comparator | Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychosocial stress | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 weeks |
| 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 | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Postprandial Insulin Response Without Stress Exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92617 | United States | ||
| UCI Medical Center, University of California, Irvine |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low GI Meal - Stress, Then No Stress | Participants assigned to this group consumed a low glycemic index breakfast at both study visits (nutrition shake high in fiber with minimal added sugars). On the first study visit they were exposed to the standardized stress task (TSST), followed by a 1-2 weeks washout period, followed by their second study visit with the standardized non-stress task. At both study visits, 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. |
| FG001 | Low GI Meal - No Stress, Then Stress | Participants assigned to this group consumed a low glycemic index breakfast at both study visits (nutrition shake high in fiber with minimal added sugars). On the first study visit they were exposed to the standardized non-stress task, followed by a 1-2 week washout period, followed by their second study visit with the standardized stress task (TSST). At both study visits, 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. |
| FG002 | High GI Meal - Stress, Then No Stress | Participants assigned to this group consumed a high glycemic index breakfast at both study visits (nutrition shake high in added sugars and low in fiber, plus a portion of apple sauce). On the first study visit they were exposed to the standardized stress task (TSST), followed by a 1-2 week washout period, followed by their second study visit with the standardized non-stress task. At both study visits, 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. |
| FG003 | High GI Meal - No Stress, Then Stress | Participants assigned to this group consumed a high glycemic index breakfast at both study visits (nutrition shake high in added sugars and low in fiber, plus a portion of apple sauce). On the first study visit they were exposed to the standardized non-stress task, followed by a 1-2 week washout period, followed by their second study visit with the standardized stress task (TSST). At both study visits, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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Population for baseline analysis matches the number of participants who started the first intervention in Participant Flow section
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Posted | Mean | Standard Deviation | mg/dl * minutes | 2 weeks |
|
from enrollment until end of follow-up, up to 8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psychosocial Stress | Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI). All participants also complete the non-stress task following consumption of their assigned meal type on a different day in a crossover design. |
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Could not obtain an assay to test free fatty acids from plasma samples so we were unable to fulfill the aim of assessing the impact of stress exposure on postprandial fatty acid response to the meals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Lindsay | University of California, Irvine | 949-824-0148 | kllindsa@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2022 | Jul 30, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2020 | Jul 30, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D006943 | Hyperglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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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.
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| Control non-stress | Behavioral | Participants will have a relaxed 15 minute conversation with a familiar research team member. |
|
Insulin response (area-under-the-curve) to the assigned meal type during the visit with the non-stress control condition
| 2 weeks |
| Orange |
| California |
| 92868 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Pre-pregnancy body mass index (ppBMI) | Computed based on self-reported pre-pregnancy weight and height | Mean | Standard Deviation | Kg/m^2 |
|
| OG001 | High GI Meal | Participants assigned to this group consumed a high glycemic index breakfast at both study visits (i.e. before the standardized stress task during one visit and before non-stress task during the other visit). 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. |
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | mg/dl * minutes | 2 weeks |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | uU/ml * minutes | 2 weeks |
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | uU/ml * minutes | 2 weeks |
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| 0 |
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |