An interventional study of Betaine supplement in Breast Milk Fortifier Supplements, sponsored by Fundació Sant Joan de Déu. Active, not recruiting at 1 site in Spain. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Basic science
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.
Fundació Sant Joan de Déu is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive oral betaine supplementation at a low dose (400 milligrams/day) for one week, followed by a high dose (1.5 grams/day) for one additional week. Milk samples will be collected at baseline and at multiple time points to evaluate betaine dynamics, accumulation, and associated metabolic changes.
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.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events, focusing on gastrointestinal symptoms.
Time frame: Baseline, 1 week, 2 weeks
Change in betaine concentration in human milk
Variation in betaine levels in breast milk measured at baseline (0 hours) and at 3 hours, 6 hours, and 12 hours after taking supplement
Time frame: Baseline (0, 3, 6, 12 hours), 1 week (0, 3, 6, 12 hours), 2 weeks (0, 3, 6, 12 hours)
Changes in the one-carbon metabolite profile of breast milk
Milk samples will be analyzed by liquid chromatography-mass spectrometry to quantify betaine-related metabolites, including dimethylglycine, methionine, S-adenosylmethionine, S-adenosylhomocysteine, cystathionine, choline, homocysteine, methyl folate, and folic acid at the different time-points.
Time frame: Baseline (0, 3, 6, 12 hours), 1 week (0, 3, 6, 12 hours), 2 weeks (0, 3, 6, 12 hours)
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Fundació Sant Joan de Déu