Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) — Baseline, 1 week, 2 weeks
  Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events, focusing on gastrointestinal symptoms.
• Change in betaine concentration in human milk — Baseline (0, 3, 6, 12 hours), 1 week (0, 3, 6, 12 hours), 2 weeks (0, 3, 6, 12 hours)
  Variation in betaine levels in breast milk measured at baseline (0 hours) and at 3 hours, 6 hours, and 12 hours after taking supplement

Trial sites (1)

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