Evolutionary Nutrition Pilot: Enhancing Fetal Growth and Brain Development

NCT05242224 | Active Not Recruiting

• 1 other identifier: 2019-044E
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (14)

• Length-for-age Z (LAZ)

  LAZ is a measure of stunting, whether a child is the appropriate length/height for their age

  6 months

• Plasma concentrations of Docosahexaenoic acid (DHA)

  Plasma concentration of DHA measured in µg/mL

  6 months

• Plasma concentrations of Linoleic acid (LA)

  Plasma concentration of LA measured in µg/mL

  6 months

• Plasma concentrations of α-Linoleic acid (ALA)

  Plasma concentration of ALA measured in µg/mL

  6 months

• Plasma concentrations of Betaine

  Plasma concentration of Betaine measured in µg/mL

  6 months

• Plasma concentrations of Methionine

  Plasma concentration of Methionine measured in µg/mL

  6 months

• Plasma Concentration of Choline

  Plasma concentration of Choline measured in µg/mL

  6 months

• Plasma Concentration of Iron (Fe)

  Plasma concentration of Iron (Fe) measured in mg/mL

  6 months

• Plasma Concentration of Zinc (Zn)

  Plasma concentration of Zinc (Zn) measured in mg/mL

  6 months

• Plasma Concentration of Selenium (Se)

  Plasma concentration of Selenium (Se) measured in mg/mL

  6 months

• Brain structure development--Gangliothalamic ovoid (GTO) volume

  GTO volume measured in cm3

  4 months

• Brain structure development--Gangliothalamic ovoid (GTO) diameter

  GTO diameter measured in cm

  4 months

• Brain structure development--Gangliothalamic ovoid (GTO) craniocaudal

  GTO craniocaudal measured in cm

  4 months

• Brain structure development-- thalamic diameter

  Thalamic diameter in cm

  4 months

Secondary Outcomes (1)

• Maternal Morbidity

  6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Receives evolutionary nutrition package \[high quality diet plus nutrition messaging + standard of care (iron-folic acid and calcium supplements)\]

Other: Evolutionary Nutrition Package

Control Group

NO INTERVENTION

Receives standard-of-care, iron-folic acid and calcium supplements.

Interventions

Evolutionary Nutrition Package OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy
• in their first trimester
• carrying a singleton pregnancy

You may not qualify if:

• less than 18 years of age
• have a chronic health condition (HIV, TB, epilepsy, etc.)
• have a multiple pregnancy (twins, triplets, etc.)
• intend to move away from the study area
• have known allergies to eggs or fish
• have a blood pressure greater than 160/100

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Children's Discovery Institute: collaborator
• Universidad San Francisco de Quito: collaborator
• St. Louis Children's Hospital: collaborator

Study Sites (1)

Universidad San Francisco de Quito

Quito, Pichincha, 170901, Ecuador

Location

MeSH Terms

Conditions

Growth Disorders; Fetal Nutrition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ivan Palacios, MD

  Universidad San Francisco de Quito

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: February 16, 2022
• Study Start: January 5, 2022
• Primary Completion: August 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

EC (1)