Emotion-Diet Interactions in Pregnancy (PREDIP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04430439|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Related Stress, Psychological Glucose Intolerance During Pregnancy Emotional Stress Postprandial Hyperglycemia Insulin Sensitivity/Resistance||Behavioral: Psychosocial stress Behavioral: Control non-stress||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Crossover Assignment|
|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.|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Postprandial Response to Emotion-Diet Interactions in Pregnancy|
|Actual Study Start Date :||May 11, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: Psychosocial stress
Participants will complete the Trier Social Stress Test (TSST) immediately following consumption of their assigned meal type (low or high GI).
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.
Active Comparator: Control non-stress
Participants will complete a non-stress relaxed task immediately following consumption of their assigned meal type (low or high GI).
Behavioral: Control non-stress
Participants will have a relaxed 15 minute conversation with a familiar research team member.
- Postprandial glycemic response [ Time Frame: 2 weeks ]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
- Postprandial lipid response [ Time Frame: 2 weeks ]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 [ Time Frame: 2 weeks ]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 [ Time Frame: 3 hours ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04430439
|Contact: Karen Lindsayemail@example.com|
|United States, California|
|University of California, Irvine||Recruiting|
|Irvine, California, United States, 92617|
|Contact: Karen Lindsay 949-824-0148 firstname.lastname@example.org|