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Diet soda during pregnancy? new study tests if cutting them helps babies

NCT ID NCT06548828

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

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Recruitment status, easiest to join first

Recruiting now This study
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.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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)

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Expanded access (paused)
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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

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether avoiding non-nutritive sweeteners (like those in diet sodas) during pregnancy and breastfeeding can lower babies' risk of obesity and improve mothers' blood sugar control. About 324 pregnant women who regularly consume these sweeteners will be split into groups: some will stop during pregnancy and breastfeeding, some only during breastfeeding, and some will continue as usual. The goal is to see if these changes affect baby body fat, mom's glucose levels, and baby gut health.

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

About 324 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

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 to 45 years

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: * Pregnant * ≤ 16 weeks gestation * Singleton pregnancy * Report frequent NNS beverage consumption (≥ 7 servings/week) * 18-45 years of age * Able to read English at a 5th grade level; and * Intend to breastfeed for at least the first 6 months of life. * For infants: The mother must be enrolled and provide assent for the infant to participate. Exclusion Criteria: * Physical or mental concerns preventing study participation; * Medication (e.g., metformin; GLP-1 agonists) use that may affect body weight, body composition, insulin resistance, or lipid profiles; * Tobacco or drug use during pregnancy; * Alcohol consumption (\>1 drink per week) during pregnancy; * Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn's disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota; * Known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects. * History of prior gastric bypass surgery.

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Conditions

The condition(s) this trial relates to.

Breast Feeding gestational diabetes

As listed by the trial registrant

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

Gestational diabetes mellitus in pregnancy Glucose intolerance during pregnancy Non-nutritive sweeteners consumption in pregnancy and/or lactation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The George Washington University

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

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