DepressionNCT05619445
Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health
A study testing Whole Liquid Egg and Plant-based Egg Substitute in people with Depression and Anxiety, run by University of Idaho at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Whole Liquid Egg and Plant-based Egg Substitute
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 26 weeks pregnant
- have access to internet and an electronic device (phone, tablet, or computer)
- willing to consume eggs
Who cannot join
- 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
Show all 9Show fewer
- have diagnosed egg allergy
- have physical, cognitive, or logistical limitations to being able to follow the study protocol
- do not plan to breastfeed
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- 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.
- 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.
Read more
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.
Read the detailed description
Subjects will be recruited from community sites, such as health clinics and recreation centers. Practitioners and recreation center directors will collaborate by sharing a recruitment flyer with patients and clients. Doctor's clearance is not required for participation, but potential subjects may discuss the study with their physician. Potential subjects will complete an online screening form. Eligible subjects (n=30) will be 18 to 26 weeks pregnant (at study start, mid-July), have access to internet and an electronic devise (phone, tablet, or computer), and be willing to consume eggs and consent to study participation. Eligible subjects will be sent an electronic informed consent and be contacted by study personnel. Study personnel will review the consent either in person, via phone, or via zoom. Those eligible for the study will be randomly assigned to the dietary intervention groups: whole liquid eggs (n=15) or plant-based liquid egg substitute (JUST Egg) (n=15).
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
- Depression, Anxiety, Stress
- Being tested
- Whole Liquid Egg, Plant-based Egg Substitute
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Liquid EggOther
Subjects will consume 2 fluid ounces of whole liquid eggs per day for 120 days.
Plant-based Egg SubstituteOther
Subjects will consume 2 fluid ounces of liquid plant-based egg substitute (JUST eggs) per day for 120 days.
| Study group | Role | What they receive |
|---|---|---|
| Whole Liquid Egg | Experimental | Whole Liquid Eggs Receives: Other: Whole Liquid Egg |
| Plant-Based Egg Substitute | Experimental | Plant-Based Egg Substitute Receives: Other: Plant-based Egg Substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Choline
Blood will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry
Measured: Baseline
Serum Choline
Blood will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry
Measured: 4-6 weeks postpartum
Adherence
Daily photo and written diet logs will be analyzed to determine dietary intake of the intervention foods
Measured: 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.
Measured: Through study completion, approximately 4 months
Secondary outcomes (11)
Breastmilk Choline
Breastmilk will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry
Measured: 4-6 weeks postpartum
Depression
Maternal depressive symptoms will be measured via the Edinburgh Postnatal Depression Scale. Maximum score is 30. Higher scores indicate increased symptoms of depression.
Measured: Baseline
Depression
Maternal depressive symptoms will be measured via the Edinburgh Postnatal Depression Scale. Maximum score is 30. Higher scores indicate increased symptoms of depression.
Measured: 4-6 weeks postpartum
Anxiety
Maternal anxiety will be measured with the 31-item perinatal anxiety screening scale. Maximum score is 93. Higher scores indicate higher symptoms of anxiety.
Measured: Baseline
Anxiety
Maternal anxiety will be measured with the 31-item perinatal anxiety screening scale. Maximum score is 93. Higher scores indicate higher symptoms of anxiety.
Measured: 4-6 weeks postpartum
Stress
Maternal perceived stress levels will be characterized via the Perceived Stress Scale. The maximum score is 56. Higher scores indicate higher levels of perceived stress.
Measured: Baseline
Stress
Maternal perceived stress levels will be characterized via the Perceived Stress Scale. The maximum score is 56. Higher scores indicate higher levels of perceived stress.
Measured: 4-6 weeks postpartum
Perceived social support
Subjects will complete the Multidimensional Scale of Perceived Social Support. The maximum score is 7. Higher scores indicate higher levels of perceived support.
Measured: Baseline
Perceived social support
Subjects will complete the Multidimensional Scale of Perceived Social Support. The maximum score is 7. Higher scores indicate higher levels of perceived support.
Measured: 4-6 weeks postpartum
Serum cortisol
Blood draw will be analyzed for concentration of serum cortisol using an enzyme-linked immunosorbent assay
Measured: Baseline
Serum cortisol
Blood draw will be analyzed for concentration of serum cortisol using an enzyme-linked immunosorbent assay
Measured: 4-6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start9 Jun 2023
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nevada, Las Vegas, University of New Mexico
- Responsible party
- Sponsor
- Investigators
- Annie J Roe, PhD, Principal investigator, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619445
- Sponsor's protocol ID
- 21-117
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2022
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health
- ClinicalTrials.gov ID
- NCT05619445
- Acronym / sponsor ID
- 21-117
- Conditions
- Depression, Anxiety, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Collaborators
- University of Nevada, Las Vegas, University of New Mexico
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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
Subjects will be recruited from community sites, such as health clinics and recreation centers. Practitioners and recreation center directors will collaborate by sharing a recruitment flyer with patients and clients. Doctor's clearance is not required for participation, but potential subjects may discuss the study with their physician. Potential subjects will complete an online screening form. Eligible subjects (n=30) will be 18 to 26 weeks pregnant (at study start, mid-July), have access to internet and an electronic devise (phone, tablet, or computer), and be willing to consume eggs and consent to study participation. Eligible subjects will be sent an electronic informed consent and be contacted by study personnel. Study personnel will review the consent either in person, via phone, or via zoom. Those eligible for the study will be randomly assigned to the dietary intervention groups: whole liquid eggs (n=15) or plant-based liquid egg substitute (JUST Egg) (n=15).
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Liquid Egg | Experimental | Other: Whole Liquid EggWhole Liquid Eggs |
| Plant-Based Egg Substitute | Experimental | Other: Plant-based Egg SubstitutePlant-Based Egg Substitute |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 26 weeks pregnant
- have access to internet and an electronic device (phone, tablet, or computer)
- willing to consume eggs
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Liquid EggSubjects will consume 2 fluid ounces of whole liquid eggs per day for 120 days. | Other | Whole Liquid Egg |
| Plant-based Egg SubstituteSubjects will consume 2 fluid ounces of liquid plant-based egg substitute (JUST eggs) per day for 120 days. | Other | Plant-Based Egg Substitute |
Primary outcome
Serum Choline
Time frame: Baseline
Blood will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry
Serum Choline
Time frame: 4-6 weeks postpartum
Blood will be collected and analyzed via liquid chromatography-stable isotope dilution-multiple reaction monitoring mass spectrometry
Adherence
Time frame: Daily through the dietary intervention (120 days)
Daily photo and written diet logs will be analyzed to determine dietary intake of the intervention foods
Feasibility/Compliance
Time frame: Through study completion, approximately 4 months
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.
11 secondary outcomes
Breastmilk Choline
Time frame: 4-6 weeks postpartum
Depression
Time frame: Baseline
Depression
Time frame: 4-6 weeks postpartum
Anxiety
Time frame: Baseline
Anxiety
Time frame: 4-6 weeks postpartum
Stress
Time frame: Baseline
Stress
Time frame: 4-6 weeks postpartum
Perceived social support
Time frame: Baseline
Perceived social support
Time frame: 4-6 weeks postpartum
Serum cortisol
Time frame: Baseline
Serum cortisol
Time frame: 4-6 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annie J Roe, PhD principal investigator
University of Idaho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Liquid Egg and Plant-based Egg Substitute in people with Depression and Anxiety, run by University of Idaho at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Choline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.