Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

In this study, the investigators will evaluate the dynamics of betaine excretion into breast milk following supplementation. Milk betaine concentrations will be measured at baseline (0 hours) and at 3, 6, and 12 hours after the first dose of 400 milligrams (mg) betaine to assess the short-term impact of maternal betaine supplementation on milk betaine concentration and related metabolites during 12 hours after intake. These measurements will be repeated after one week of daily supplementation with this low dose. Subsequently, the same protocol will be conducted using a higher dose (1.5 gram/day) for one additional week to compare milk betaine concentration and related metabolites before and after the supplementation period at two different doses. Depending on the outcomes, the investigators will also analyze milk macronutrient composition and explore untargeted metabolomic changes.

NCT Number	NCT07243678
Lead Sponsor	Fundació Sant Joan de Déu
Conditions	Breast Milk Fortifier Supplements
Enrollment	10 participants
Start Date	2025-10-30
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-20