NCT03744429 is a NA clinical trial of Mediterranean Diet in Effect of Diet on Breast Milk Composition, sponsored by Arkansas Children's Hospital Research Institute.

Who is sponsoring NCT03744429?

NCT03744429 is sponsored by Arkansas Children's Hospital Research Institute.

What drugs are being tested in NCT03744429?

Interventions in NCT03744429: Mediterranean Diet.

What condition does NCT03744429 study?

NCT03744429 studies Effect of Diet on Breast Milk Composition.

Is NCT03744429 still recruiting?

NCT03744429 is currently completed. Last updated 30 September 2025.

Last reviewed 2025-09-30 · How we verify

NCT03744429

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women

Completed NA Last updated 30 September 2025

What this trial tests

NA trial testing Mediterranean Diet in Effect of Diet on Breast Milk Composition in 32 participants. Completed in 30 September 2024.

Timeline

16 April 2019

Primary endpoint
13 March 2024

30 September 2024

Quick facts

Lead sponsor	Arkansas Children's Hospital Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	32
Start date	16 April 2019
Primary completion	13 March 2024
Estimated completion	30 September 2024
Sites	1 location across United States

Drugs / interventions tested

Mediterranean Diet

Conditions studied

Effect of Diet on Breast Milk Composition — all drugs for Effect of Diet on Breast Milk Composition →

Sponsor

Arkansas Children's Hospital Research Institute

Who can join

18 and older, female only, with Effect of Diet on Breast Milk Composition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A Mediterranean diet plan in lactating women with obesity reduces maternal energy intake and modulates human milk composition - a feasibility study.
Sims CR, Saben JL, Martinez A, Sobik SR, et al · · 2024 · cited 7× · PMID 38544749 · DOI 10.3389/fnut.2024.1303822
Dietary modulation of human milk bioactives is associated with maternal FUT2 secretor phenotype: an exploratory analysis of carotenoids and polyphenol metabolites.
Fiecke C, Crimmins M, Hameed A, Sims C, et al · · 2024 · cited 2× · PMID 39444568 · DOI 10.3389/fnut.2024.1463969

Verify or expand the search:

Other trials of Mediterranean Diet

Trials testing the same drug.

NCT07446777 — FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Pre · NA · not yet recruiting
NCT07442799 — Efficacy of a Culturally-adapted Mediterranean Diet Intervention on Depression in Relation to the Gut Microbiome · NA · not yet recruiting
NCT04772651 — Mediterranean Diet and the Microbiota Gut Brain Axis in Major Depression · NA · not yet recruiting
NCT07189637 — The Combined Effect of the Mediterranean Diet and Intermittent Fasting on Hypertension · NA · not yet recruiting
NCT07200934 — Effect of Adding TENS to Mediterranean Diet on Appetite and Liver Enzymes in Nonalcoholic Fatty Liver Patients · NA · not yet recruiting

Other Arkansas Children's Hospital Research Institute trials

Trials by the same sponsor.

NCT06929091 — Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready · NA · recruiting
NCT06848478 — Level Up! (The Combined and Independent Effects of Exercise Training and Dietary Enhancement on Cardiometabolic Health i · NA · not yet recruiting
NCT06666257 — Continuous Glucose and E-Monitoring to Support Healthy Weight Gain in Pregnancies - The GEM Study · NA · not yet recruiting
NCT07107321 — Deimplementation of Inappropriate Feeding Practices in Early Care and Education Settings · NA · enrolling by invitation
NCT07346300 — We-Move With Windy: Gross Motor Development for Early Childhood · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03744429 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Arkansas Children's Hospital Research Institute
Last refreshed: 30 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03744429.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing