Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

N/ANot Yet RecruitingNCT07243678

Fundació Sant Joan de Déu10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Breast Milk Fortifier Supplements

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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.