Active — Not RecruitingNot Applicable

Evolutionary Nutrition Pilot: Enhancing Fetal Growth and Brain Development

Ecuador200 participantsStarted 2022-01-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * healthy * in their first trimester * carrying a singleton pregnancy Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Length-for-age Z (LAZ)

Timeframe: 6 months

Plasma concentrations of Docosahexaenoic acid (DHA)

Timeframe: 6 months

Plasma concentrations of Linoleic acid (LA)

Timeframe: 6 months

Plasma concentrations of α-Linoleic acid (ALA)

Timeframe: 6 months

Plasma concentrations of Betaine

Timeframe: 6 months

Plasma concentrations of Methionine

Timeframe: 6 months

Plasma Concentration of Choline

Timeframe: 6 months

Plasma Concentration of Iron (Fe)

Timeframe: 6 months

Trial details

NCT IDNCT05242224

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01

View on ClinicalTrials.gov More Growth Disorders trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Length-for-age Z (LAZ)

Timeframe: 6 months

Plasma concentrations of Docosahexaenoic acid (DHA)

Timeframe: 6 months

Plasma concentrations of Linoleic acid (LA)

Timeframe: 6 months

Plasma concentrations of α-Linoleic acid (ALA)

Timeframe: 6 months

Plasma concentrations of Betaine

Timeframe: 6 months

Plasma concentrations of Methionine

Timeframe: 6 months

Plasma Concentration of Choline

Timeframe: 6 months

Plasma Concentration of Iron (Fe)

Timeframe: 6 months