East Carolina University
Greenville, North Carolina, 27858, United States
Location status: Recruiting
Location contact
Ericka M Biagioni, PhD, RDN
CONTACT
Linda May, MS, PhD
CONTACT
NCT Number: NCT07525193
Less than 10% of pregnant women consume adequate levels of choline, an essential nutrient for maternal lipid metabolism, placental efficiency, and fetal development. Most prenatal vitamins do not contain choline; a research survey shows that only 6% of OB/GYNs were likely to recommend choline-rich foods to pregnant women. Nutrition education grounded in the Health Belief Model (HBM) has high efficacy among pregnant women; therefore, it is likely that HBM-driven choline education intervention will increase maternal choline levels. No studies have evaluated the influence of prenatal choline education intervention on maternal, placental, and neonatal outcomes. Our preliminary data suggest that increased choline intake corresponds with lower maternal body fat percentage (BF%), infant 1-month BF%, and MSC lipid accumulation, as well as increased placental efficiency. The central hypothesis is that choline education will increase maternal choline levels and improve placental function and infant health. We will test this hypothesis with three aims: to determine the influence of choline education intervention on maternal choline intake, placental efficiency, and infant health at the whole-body and cellular levels. The proposed study will be the first to provide a critical translational understanding of the influence of prenatal choline education intervention on maternal, placental, and child health.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Greenville, North Carolina, 27858, United States
Location status: Recruiting
Ericka M Biagioni, PhD, RDN
CONTACT
Linda May, MS, PhD
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All choline nutrition education (CNE) will be delivered virtually once every 4 weeks at Gestational Week 18, 22, 26, 30, and 34. Participants will also receive a check-in message at Gestational Week 20, 24, 28, and 32, asking them to confirm that they have read through the CNE materials and if they have any questions.
Time frame: At 16-weeks and 36-weeks gestation: Participants will complete the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool on 3 separate days (2 weekdays and 1 weekend day) to determine daily dietary choline intake in grams.
Multiple 24-hour dietary recalls
Time frame: At 1-month postnatal: Infant body composition will be evaluated at 1-month by DXA scan.
DXA scan to measure body fat percentage in 1-month old infants.
Time frame: At 16-weeks and 36-weeks gestation: Maternal blood will be collected and centrifuged, then a colorimetric plate-based assay (Choline Assay Kit, ab219944) will be used to quantify choline concentrations in maternal plasma samples.
Maternal venipuncture
Time frame: At delivery: Infant mesenchymal stem cells (MSCs) will be isolated from umbilical cord tissue and Oil-Red O staining will be used to measure intracellular lipid accumulation of adipogenic differentiated MSCs.
At delivery: Infant mesenchymal stem cells (MSCs) will be isolated from umbilical cord tissue. Undifferentiated MSCs (D0) will be cultured in growth medium, and adipogenesis will be induced for 21 days (D21). Adipogenic differentiation will be confirmed by western blotting for protein expression of adipogenic marker PPARγ at D0 and D21. Cellular lipid accumulation will be evaluated in MSCs at D0 and D21 using Oil Red O (ORO) staining.
Time frame: At 16-weeks and 36-weeks gestation: Maternal body composition will be assessed by BOD POD (COSMED).
Maternal body composition will be assessed by BOD POD (COSMED) to determine fat mass.
Contact information is provided by the study sponsor or research team.
East Carolina University
Other
Acronym: PRECIOUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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