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NCT05619445
Feasibility of Egg-Based Diet Interventions and Assessing Perinatal Mental Health
NA trial testing Whole Liquid Egg in Depression in 1 participant. Completed in 20 October 2023.
20 October 2023
Quick facts
| Lead sponsor | University of Idaho |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 1 |
| Start date | 9 June 2023 |
| Primary completion | 20 October 2023 |
| Estimated completion | 20 October 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Whole Liquid Egg
- Plant-based Egg Substitute
Conditions studied
- Depression — all drugs for Depression →
- Anxiety — all drugs for Anxiety →
- Stress — all drugs for Stress →
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:
- PubMed search for NCT05619445
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05619445 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Idaho
- Last refreshed: 6 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05619445.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing