NCT07243678

Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Fundació Sant Joan de Déu · Academic / Other
• Sex: Female
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Breast Milk Fortifier Supplements

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Betaine supplement	Oral betaine supplementation will be administered to lactating women. Participants will receive a dose of 400 milligrams/day for 1 week, followed by 1.5 grams/day for an additional week.

Timeline

• Start date: 2025-10-30
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-11-24
• Last updated: 2026-03-20

Locations

1 site across 1 country: Spain