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Diet soda sweeteners found in breast milk – what does that mean for babies?

NCT ID NCT05379270

Knowledge-focused Sponsor: George Washington University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether two common low-calorie sweeteners (sucralose and acesulfame-potassium) from diet soda pass into breast milk and then into a baby's blood. 82 breastfeeding mothers drank one diet soda, and researchers measured sweetener levels in their milk and blood over 72 hours, plus one sample from each baby. The goal was to see if these sweeteners actually reach infants, which would help design future studies on possible health effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
diet soda containing sucralose and acesulfame-potassium
What this could lead to
If it shows these sweeteners do pass into breast milk, it could lead to larger studies on whether early exposure affects infant health.
What could go wrong
This is a small, short-term study that only measures levels, not health effects. It cannot tell us if any exposure is harmful or safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

82 people

The number who actually took part.

Started

Feb 2022

Finished

Dec 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * mother gave birth within the past 6 months * mother ≥18 years of age * exclusively breastfeeding * reports consumption of diet, low-calorie sweetener-containing beverages ≥ 1 time per week. * infants' corrected age \>= 4 weeks Exclusion Criteria: * known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother) * active nutritional disorder known to cause malabsorption

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breastfeeding

Contacts and locations

Locations

  • The George Washington University

    Washington D.C., District of Columbia, 20052, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.