Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evolutionary Nutrition Pilot: Enhancing Fetal Growth and Brain Development
Sponsor: Washington University School of Medicine
Summary
Globally, 250 million children do not reach their developmental potential and 155 million are stunted, yet few population-based studies have examined the direct effects of nutrient deficiencies on early brain development. This study will examine an evolutionary nutrition intervention during pregnancy derived from diets consumed for 99.9% of hominin history when bodies and brains were healthier. A pilot clinical trial will be conducted in the central highlands of Ecuador to compare fetal and newborn outcomes among women randomized to: 1) evolutionary nutrition package (high quality diet plus nutrition messaging); and 2) control (standard-of care supplements). Ultrasound brain measures, nutrition and morbidity data, and blood metabolomics will be assessed at 21 weeks gestational age, 37 weeks gestational stage, and postpartum. This pilot study uniquely combines the expertise of multiple disciplines - public health nutrition, radiology, neuroscience, and metabolomics - to examine the potential for improved nutrition on early growth and brain development with vital public health implications.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-01-05
Completion Date
2025-06
Last Updated
2024-10-28
Healthy Volunteers
Yes
Conditions
Interventions
Evolutionary Nutrition Package
The evolutionary nutrition package includes two key components: 1) one full meal per day from the evolutionary nutrition (EN) plate; 2) targeted messaging for high quality nutrition and removal of ultra-processed foods from the diet. The EN plate includes five food groups identified from the literature on evolutionary diets: animal source foods (ASF); berries and other fruits; tubers; vegetables, herbs and spices; and nuts and other legumes.
Locations (1)
Universidad San Francisco de Quito
Quito, Pichincha, Ecuador