Active, Not Recruiting

NCT Number: NCT07243678

Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Milk Fortifier Supplements

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Deu

Barcelona, 08950, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Betaine supplement

Dietary 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.

Primary outcomes

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

Time frame: 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

Time frame: 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

Secondary outcomes

Changes in the one-carbon metabolite profile of breast milk

Time frame: Baseline (0, 3, 6, 12 hours), 1 week (0, 3, 6, 12 hours), 2 weeks (0, 3, 6, 12 hours)

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.

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Acronym: BetMilkII

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Nov 24, 2025
Registry last updated: Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.