Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health

NCT05619445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-12-06

No results posted yet for this study

Summary

The goals of this study are to assess the feasibility and acceptability of a dietary intervention to increase choline intake through whole foods (eggs) in pregnant and lactating women for mental health benefits. We will achieve these goals through the following specific aims:

1. To determine the effects of including eggs as a source of choline in the diets of pregnant and lactating women on biomarkers, we will measure concentrations of choline and choline metabolites in maternal serum and breastmilk at 24-26 weeks gestation and 4-6 weeks postpartum.
2. To evaluate adherence to a food-based dietary choline intervention in pregnant and lactating women, we will track intake via daily photo and written food logs.
3. To assess the feasibility of collecting repeated measures of dietary intake and maternal depression, anxiety, and stress in the perinatal period, we will track completion rates for project surveys.

The data from this study will inform the design and sample size calculations for a longitudinal cohort study that will assess neurological outcomes for both mother and child and follow the offspring over time to reassess mental health and cognitive development in preschool-aged children.

Choline is an underconsumed nutrient of concern for public health, specifically during pregnancy and lactation. There is limited data on biomarker or health outcomes related to perinatal choline intake. Determining relationships between perinatal choline intake and maternal mental health has the potential to impact public health by ultimately informing development of nutrition education materials in the clinical setting focused on encouraging maternal perinatal choline intake through whole foods such as eggs.

Conditions

Interventions

OTHER

Whole Liquid Egg

Subjects will consume 2 fluid ounces of whole liquid eggs per day for 120 days.

OTHER

Plant-based Egg Substitute

Subjects will consume 2 fluid ounces of liquid plant-based egg substitute (JUST eggs) per day for 120 days.

Sponsors & Collaborators

  • University of Nevada, Las Vegas

    collaborator OTHER
  • University of New Mexico

    collaborator OTHER
  • University of Idaho

    lead OTHER

Principal Investigators

  • Annie J Roe, PhD · University of Idaho

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-09
Primary Completion
2023-10-20
Completion
2023-10-20

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05619445 on ClinicalTrials.gov