Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health
NCT ID: NCT05619445
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1 participants
INTERVENTIONAL
2023-06-09
2023-10-20
Brief Summary
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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.
Detailed Description
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After consenting, subjects will complete baseline surveys. Baseline survey data collected will include an online demographic and health history questionnaire, food frequency questionnaire, 24-hour dietary recall, and self-report surveys to assess depressive symptoms, anxiety, perceived stress, and perceived social support. Subjects will complete all assessments online (via Qualtrics) using their own electronic devices, including phone, tablet, or computer, from the comfort of their own home.
Subjects will then be scheduled to come to the Ramsay Research unit (RRU) for fasted blood draw (overnight fast, 8 hours). Subjects will be scheduled between 7:30am and 11am. The RRU is not a CLIA-certified laboratory. It is an approved research laboratory. Blood will be processed at the RRU and sent to the Chen lab on the UI Moscow campus for cortisol analysis and to the University of North Carolina Nutrition Research Institute for choline analysis. At this baseline visit, subjects will also receive the first 30 day supply of the assigned dietary intervention along with a simple recipe book to offer ideas for preparation in case subjects are not familiar with how to prepare liquid eggs and to reduce monotony and palate fatigue. Subjects will also receive a measuring cup and a diet log along with instructions for consuming the intervention food and reporting intake daily via photos and written log. Researchers will answer any questions. Subjects will receive baseline data collection compensation.
Subjects will pick up additional dietary intervention products at the Carmelita Spencer Foods laboratory every 30 days (total of 120 days). Alternatively, research personnel will deliver products to subjects' homes in the Moscow area.
Subjects will be asked to take a photo of each meal that incorporates their assigned dietary intervention food before and after eating. These photos will be sent to the study phone via text message and uploaded to the PI's secure university One Drive account.
Subjects will be asked to complete additional online 24-hour diet recalls at week 9-10 of the intervention (about week 35-36 gestation), and week 18-19 of the intervention (about 4-5 weeks postpartum).
At week 4-6 postpartum, subjects will complete a short survey online describing birth-related outcomes and experience and self-report surveys to assess depressive symptoms, anxiety, perceived stress, and perceived social support.
Also at 4-6 weeks postpartum, subjects will come to the Ramsay Research Unit for fasted blood draw (overnight fast, 8 hours) and to provide a sample of breastmilk. Subjects will be scheduled between 7:30am and 11am. Subjects will be asked to refrain from feeding their infant on one breast for the 2 hours prior to collection. An electronic breast pump will be provided and a lactation specialist will be available to assist in this collection. Subjects will be asked for a full expression from one breast. Blood will be processed as described above. Breastmilk will sent to the UNC Nutrition Research Institute for choline analysis.
This will complete the data collection and subjects will receive study completion compensation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Whole Liquid Egg
Whole Liquid Eggs
Whole Liquid Egg
Subjects will consume 2 fluid ounces of whole liquid eggs per day for 120 days.
Plant-Based Egg Substitute
Plant-Based Egg Substitute
Plant-based Egg Substitute
Subjects will consume 2 fluid ounces of liquid plant-based egg substitute (JUST eggs) per day for 120 days.
Interventions
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Whole Liquid Egg
Subjects will consume 2 fluid ounces of whole liquid eggs per day for 120 days.
Plant-based Egg Substitute
Subjects will consume 2 fluid ounces of liquid plant-based egg substitute (JUST eggs) per day for 120 days.
Eligibility Criteria
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Inclusion Criteria
* have access to internet and an electronic device (phone, tablet, or computer)
* willing to consume eggs
Exclusion Criteria
* 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
19 Years
FEMALE
Yes
Sponsors
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University of Nevada, Las Vegas
OTHER
University of New Mexico
OTHER
University of Idaho
OTHER
Responsible Party
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Principal Investigators
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Annie J Roe, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Idaho
Locations
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University of Idaho
Moscow, Idaho, United States
Countries
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Other Identifiers
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21-117
Identifier Type: -
Identifier Source: org_study_id