Trial Outcomes & Findings for Emotion-Diet Interactions in Pregnancy (NCT NCT04430439)

NCT ID: NCT04430439

Last Updated: 2025-08-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 113 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2025-08-22

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.	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.	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.
First Intervention STARTED	30	27	22	34
First Intervention COMPLETED	26	22	20	28
First Intervention NOT COMPLETED	4	5	2	6
Second Intervention STARTED	26	22	20	28
Second Intervention COMPLETED	22	15	20	23
Second Intervention NOT COMPLETED	4	7	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Emotion-Diet Interactions in Pregnancy

Baseline characteristics by cohort

Measure	Low GI Meal n=57 Participants 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.	High GI Meal n=56 Participants 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.	Total n=113 Participants Total of all reporting groups
Age, Continuous	28.60 years STANDARD_DEVIATION 5.45 • n=5 Participants	27.96 years STANDARD_DEVIATION 5.41 • n=7 Participants	28.28 years STANDARD_DEVIATION 5.41 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	56 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	44 Participants n=5 Participants	48 Participants n=7 Participants	92 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	19 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Pre-pregnancy body mass index (ppBMI)	30.34 Kg/m^2 STANDARD_DEVIATION 4.06 • n=5 Participants	30.86 Kg/m^2 STANDARD_DEVIATION 3.83 • n=7 Participants	30.6 Kg/m^2 STANDARD_DEVIATION 3.94 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Low GI Meal n=37 Participants Participants assigned to this group consumed a low 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.	High GI Meal n=38 Participants 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.
Postprandial Glycemic Response With Stress Exposure	12998.83 mg/dl * minutes Standard Deviation 3507.22	12833.69 mg/dl * minutes Standard Deviation 4643.66

PRIMARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Low GI Meal n=38 Participants Participants assigned to this group consumed a low 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.	High GI Meal n=45 Participants 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.
Postprandial Glycemic Response Without Stress Exposure	12754.18 mg/dl * minutes Standard Deviation 3028.18	13099.27 mg/dl * minutes Standard Deviation 4038.88

SECONDARY outcome

Timeframe: 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.

Insulin response (area-under-the-curve) to the assigned meal type during the visit with the standardized stress task

Outcome measures

Measure	Low GI Meal n=35 Participants Participants assigned to this group consumed a low 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.	High GI Meal n=34 Participants 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.
Postprandial Insulin Response With Stress Exposure	7142.74 uU/ml * minutes Standard Deviation 3329.37	10782.48 uU/ml * minutes Standard Deviation 3704.12

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	Low GI Meal n=39 Participants Participants assigned to this group consumed a low 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.	High GI Meal n=40 Participants 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.
Postprandial Insulin Response Without Stress Exposure	6791.51 uU/ml * minutes Standard Deviation 2865.53	11027.89 uU/ml * minutes Standard Deviation 3437.65

Adverse Events

Psychosocial Stress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Lindsay

University of California, Irvine

Phone: 949-824-0148

Email: kllindsa@hs.uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place