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NCT05619445

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

Completed NA Last updated 6 December 2024
What this trial tests

NA trial testing Whole Liquid Egg in Depression in 1 participant. Completed in 20 October 2023.

Timeline
9 June 2023
Primary endpoint
20 October 2023
20 October 2023

Quick facts

Lead sponsorUniversity of Idaho
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment1
Start date9 June 2023
Primary completion20 October 2023
Estimated completion20 October 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Idaho

Who can join

19 and older, female only, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Depression

Currently open trials in the same condition.

Other University of Idaho trials

Trials by the same sponsor.

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Data sources for this page

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