Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers (BetMilkII)

Fundació Sant Joan de Déu

Status: Not yet enrolling

Conditions: Breast Milk Fortifier Supplements

Treatments: Dietary Supplement: Betaine supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT07243678

PIC-142-25 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Exclusively breastfeeding
• Infant age between 2 and 5 months

Exclusion criteria

• Multiple pregnancy
• Infant weight at recruitment < -1 standard deviations (SD)
• Cystathionine Beta-Synthase (CBS) deficiency (inherited disease)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Betaine Supplementation (Sequential Low and High Dose)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Betaine supplement