NCT05619445

Brief 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

June 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

4 months

First QC Date

October 24, 2022

Last Update Submit

December 3, 2024

Conditions

DepressionAnxietyStress

Outcome Measures

Primary Outcomes (4)

  • Serum Choline

    Blood will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry

    Baseline

  • Serum Choline

    Blood will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry

    4-6 weeks postpartum

  • Adherence

    Daily photo and written diet logs will be analyzed to determine dietary intake of the intervention foods

    Daily through the dietary intervention (120 days)

  • Feasibility/Compliance

    Percent of subjects who complete all study surveys will be calculated to report feasibility of collecting repeated measures of dietary intake and mental health surveys.

    Through study completion, approximately 4 months

Secondary Outcomes (11)

  • Breastmilk Choline

    4-6 weeks postpartum

  • Depression

    Baseline

  • Depression

    4-6 weeks postpartum

  • Anxiety

    Baseline

  • Anxiety

    4-6 weeks postpartum

  • +6 more secondary outcomes

Study Arms (2)

Whole Liquid Egg

EXPERIMENTAL

Whole Liquid Eggs

Other: Whole Liquid Egg

Plant-Based Egg Substitute

EXPERIMENTAL

Plant-Based Egg Substitute

Other: Plant-based Egg Substitute

Interventions

Whole Liquid EggOTHER

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

Whole Liquid Egg
Plant-based Egg SubstituteOTHER

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

Plant-Based Egg Substitute

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 26 weeks pregnant
  • have access to internet and an electronic device (phone, tablet, or computer)
  • willing to consume eggs

You may not qualify if:

  • score 11 or higher on the Edinburgh Postnatal Depression Scale
  • under 19 years of age
  • non-English speaking
  • pregnant with multiples
  • consume a vegan diet
  • self-reported use of alcohol or drugs during pregnancy
  • have diagnosed egg allergy
  • have physical, cognitive, or logistical limitations to being able to follow the study protocol
  • do not plan to breastfeed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Idaho

Moscow, Idaho, 83844-3183, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Annie J Roe, PhD

    University of Idaho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2022

First Posted

November 16, 2022

Study Start

June 9, 2023

Primary Completion

October 20, 2023

Study Completion

October 20, 2023

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)