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Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

NCT05379270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-11-12

Study results available
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Summary

This project aims to measure the widely consumed low-calorie sweeteners (LCS) sucralose and acesulfame-potassium, in maternal breast milk and plasma at pre-specified timepoints over 72 hours and in a single sample of infants' plasma. Sucralose and acesulfame-potassium concentrations will be measured using liquid chromatography-mass spectrometry (LC-MS). The data generated will inform the design of larger, longer-term, prospective studies needed to investigate clinically-relevant consequences of early life LCS exposure in humans.

Conditions

  • Breastfeeding

Interventions

OTHER

Diet soda

Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.

Sponsors & Collaborators

  • George Washington University

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-12-02
Completion
2022-12-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05379270 on ClinicalTrials.gov