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Emotion-Diet Interactions in Pregnancy (PREDIP)

Primary Purpose

Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial stress
Control non-stress
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pregnancy Related

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, IrvineRecruiting
  • UCI Medical Center, University of California, IrvineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Psychosocial stress

Control non-stress

Arm Description

Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).

Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
June 10, 2020
Last Updated
June 29, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT04430439
Brief Title
Emotion-Diet Interactions in Pregnancy
Acronym
PREDIP
Official Title
Postprandial Response to Emotion-Diet Interactions in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Stress, Psychological, Glucose Intolerance During Pregnancy, Emotional Stress, Postprandial Hyperglycemia, Insulin Sensitivity/Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial stress
Arm Type
Experimental
Arm Description
Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
Arm Title
Control non-stress
Arm Type
Active Comparator
Arm Description
Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial stress
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control non-stress
Intervention Description
Participants will have a relaxed 15 minute conversation with a familiar research team member.
Primary Outcome Measure Information:
Title
Postprandial glycemic response
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Postprandial lipid response
Description
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
Time Frame
2 weeks
Title
Postprandial inflammatory response
Description
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
Time Frame
2 weeks
Title
Postprandial metabolic response to stress by meal type
Description
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
Time Frame
3 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Lindsay
Phone
949-824-0148
Email
kllindsa@hs.uci.edu
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92617
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Lindsay
Phone
949-824-0148
Email
kllindsa@hs.uci.edu
Facility Name
UCI Medical Center, University of California, Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Lindsay, PhD
Phone
949-824-0148
Email
kllindsa@uci.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Emotion-Diet Interactions in Pregnancy

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