Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

NCT07243678 | Active Not Recruiting

• 1 other identifier: PIC-142-25
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Milk Fortifier Supplements

Keywords

Breast milk; Betaine; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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.

  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

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

Secondary Outcomes (1)

• Changes in the one-carbon metabolite profile of breast milk

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

Study Arms (1)

Betaine Supplementation (Sequential Low and High Dose)

EXPERIMENTAL

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

Interventions

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.

Betaine Supplementation (Sequential Low and High Dose)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Exclusively breastfeeding
• Infant age between 2 and 5 months

You may not qualify if:

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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Hospital Sant Joan de Deu

Barcelona, Barcelona, 08950, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an interventional nutritional study using a within-subject design, in which lactating women receive sequential low-dose (400 milligrams/day) and high-dose (1.5 grams/day) oral betaine supplementation to assess its dynamics in breast milk.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)