Loading search results

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 supplementDietary 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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Design

Study Type

interventional

Phase

not applicable

Allocation

Masking

NONE

Purpose

BASIC SCIENCE

Intervention Model

SINGLE GROUP

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.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Pharmacokinetic Assessment of Betaine Supplementation in Lactating Mothers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Betaine Supplementation (Sequential Low and High Dose)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Study Arms (1)

Betaine Supplementation (Sequential Low and High Dose)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Design

Study Record Dates

Data Sharing

Source record

Locations