Evolutionary Nutrition Pilot: Enhancing Fetal Growth and Brain Development

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.

Conditions

• Growth Disorders
• Malnutrition, Fetal
• Stunting
• Development; Delayed, Malnutrition
• Nutrition Disorder, Fetal
• Maternal Nutritional Disorders Affecting Fetus or Newborn

Interventions

OTHER

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.

Sponsors & Collaborators

• Children's Discovery Institute

  collaborator OTHER

• Universidad San Francisco de Quito

  collaborator OTHER

• St. Louis Children's Hospital

  collaborator OTHER

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Ivan Palacios, MD · Universidad San Francisco de Quito

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-05

Primary Completion

2024-08-01

Completion

2025-06-30

Countries

• Ecuador

Study Locations