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Набира участници Не е приложимо NCT03838536

Synergistic Activity of Human Milk Nutrients and Infant Cognition

Не е приложима фаза (напр. обсервационно)
Заболявания: Breastfeeding, Exclusive

Спонсор: University of North Carolina, Chapel Hill

Налично на: БГ
Обобщение
Purpose: To establish a whole food, egg, as a viable study material to supplement mothers and infants with nutrients that support optimal brain development. There will be 84 breastfeeding dyads, 3 months postnatal. Mothers will be randomized to a whole egg or egg white (due to lack of an appropriate control food). Initial diet intake will be screened using the NDSR. Participants will come to the lab 3 times across 3 months (age 3 months, 4.5 months, and 6 months). Milk, saliva, and plasma will be collected from the mother, while saliva and plasma (heel stick) are collected from the infant. Diet data will be collected at each visit. The infant will complete a recognition memory test using electrophysiology at 6 months as well as the Bayley Scales of Infant Development at 4.5 months. The mother will complete a temperament questionnaire at 3 months and 6 months.
Кой може да участва
Inclusion Criteria: * infant is 12-15 weeks of age at enrollment * healthy, lactating mother age 18-35 * gave birth at \>38 weeks gestation without remarkable incident * consuming \<=50% of the recommended amounts of 2 of the 3, DHA, choline, and lutein Exclusion Criteria: * infant with diagnosis or documented suspicion of developmental delay * egg allergy or family history of egg allergy * gestational diabetes * any documented seizure activity
Интервенции
Whole Egg Powder
DIETARY_SUPPLEMENT
Egg White Powder
DIETARY_SUPPLEMENT
Места на провеждане 1
САЩ (1)
Nutrition Research Institute
Kannapolis , North Carolina
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
3 Months
Максимална възраст
35 Years
Здрави доброволци
Не
Начална дата
05.02.2019
Крайна дата
01.03.2027
Регистрационен номер
NCT03838536
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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