Emotion-Diet Interactions in Pregnancy

Pregnancy Related Clinical Trial

— PREDIP  

Official title:

Postprandial Response to Emotion-Diet Interactions in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430439
• Other study ID #: 20205914
• Status: Completed
• Phase: N/A
• Start date: May 11, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: February 28, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Emotional Stress
• Glucose Intolerance
• Glucose Intolerance During Pregnancy
• Hyperglycemia
• Insulin Resistance
• Insulin Sensitivity/Resistance
• Postprandial Hyperglycemia
• Pregnancy Related
• Stress, Psychological

Intervention

Behavioral:
• Psychosocial 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.
• Control non-stress
Participants will have a relaxed 15 minute conversation with a familiar research team member.

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California
United States	UCI Medical Center, University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemic response	Intra-individual glycemic response (area-under-the-curve of glucose) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task	2 weeks
Secondary	Postprandial lipid response	Intra-individual lipid response (area-under-the-curve of triglycerides and free fatty acids) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task	2 weeks
Secondary	Postprandial inflammatory response	Intra-individual lipid response (area-under-the-curve of inflammatory cytokines) to the standardized meal following exposure to either the psychosocial stress (TSST) or non-stress (control) task	2 weeks
Secondary	Postprandial metabolic response to stress by meal type	Inter-individual difference in the glycemic/lipid/inflammatory AUC in response to the TSST between participants consuming the low GI compared to the high GI meal type	3 hours