BreastfeedingNCT05379270
Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
A study testing Diet soda in people with Breastfeeding, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Diet soda
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 2 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
- active nutritional disorder known to cause malabsorption
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University
Washington D.C., District of Columbia, 20052
About this study
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.
Read the detailed description
Low-calorie sweetener (LCS) consumption is highly prevalent among lactating women, yet the current understanding of LCS effects on diet, weight, and health is extremely limited, especially when exposure begins early in life. This project aims to measure the widely consumed LCSs, sucralose and acesulfame-potassium, in maternal breast milk and plasma, at pre-specified, time-points over the course of 72 hours, and in a single sample of infants' plasma (analyzed using a population pharmacokinetics approach).
Mothers will attend an enrollment visit, which will take place virtually and will schedule an in-person visit to take place at Children's National Hospital approximately one week later. During the enrollment visit, informed consent will be obtained and demographic, anthropometric, and dietary data will be collected. During the week prior to their scheduled in-person study visit, mothers will be instructed to continue their usual dietary habits and to complete an online, photo-assisted, 7-day food record.
Mothers will be instructed to arrive fasted for the in-person visit, which will last for approximately 13 hours. Following ingestion of a diet beverage containing sucralose and ace-K, mothers will remain at Children's National for supervised serial sample collection at pre-determined time points over 12 hours, and will provide additional samples on three subsequent consecutive days (72 hours). Mothers will be instructed to continue to complete the online, photo-assisted, food record for the three days following the in-person study visit (until 72 hours following diet beverage consumption).
A plasma sample will be collected from each infant via heel-stick at one of the following pre-specified time intervals following the mother's ingestion of the diet beverage: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, 9-14 hours, and 22-36 hours.
- Conditions
- Breastfeeding
- Being tested
- Diet soda
- Keywords
- low-calorie sweeteners, sucralose, acesulfame-potassium, pharmacokinetics, breast milk, lactation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet sodaOther
Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
| Study group | Role | What they receive |
|---|---|---|
| Diet soda | Experimental | Participants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium. Receives: Other: Diet soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Sucralose Concentration in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Measured: Day 0 (immediately prior to diet beverage ingestion)
1-hour Sucralose Concentration in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 1 hour post-ingestion
2-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 2 hours post-ingestion
3-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 3 hours post-ingestion
4-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 4 hours post-ingestion
6-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 6 hours post-ingestion
8-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 8 hours post-ingestion
12-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 12 hours post-ingestion
24-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 24 hours post-ingestion
Baseline Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Measured: Day 0 (immediately prior to diet beverage ingestion)
1-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 1 hour post-ingestion
2-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 2 hours post-ingestion
3-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 3 hours post-ingestion
4-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 4 hours post-ingestion
6-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 6 hours post-ingestion
8-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 8 hours post-ingestion
12-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 12 hours post-ingestion
24-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 24 hours post-ingestion
Baseline Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Measured: Day 0 (immediately prior to diet beverage ingestion)
30-min Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 30 minutes post-ingestion
1 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 1 hour post-ingestion
1.5 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 1.5 hours post-ingestion
2 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 2 hours post-ingestion
3 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 3 hours post-ingestion
4 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 4 hours post-ingestion
6 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 6 hours post-ingestion
8 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 8 hours post-ingestion
12 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 12 hours post-ingestion
24 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 24 hours post-ingestion
48 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 48 hours post-ingestion
72 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 72 hours post-ingestion
Baseline Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Measured: Day 0 (immediately prior to diet beverage ingestion)
30 Min Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 30 minutes post-ingestion
1 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 1 hour post-ingestion
1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 1.5 hours post-ingestion
2 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 2 hours post-ingestion
3 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 3 hours post-ingestion
4 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 4 hours post-ingestion
6 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 6 hours post-ingestion
8 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 8 hours post-ingestion
12 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 12 hours post-ingestion
24 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 24 hours post-ingestion
48 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 48 hours post-ingestion
72 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: 72 hours post-ingestion
Sucralose Concentrations in Infant Plasma
Mean concentration of sucralose in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Acesulfame-potassium Concentrations in Infant Plasma
Mean concentration of acesulfame-potassium in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Measured: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start28 Feb 2022
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379270
- Sponsor's protocol ID
- NCR213471
- Status last verified
- Oct 2025
- First submitted
- 11 May 2022
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sylvetsky AC, Kuttamperoor JT, Langevin B, Murphy J, Arcaro KF, Smolyak S, Walter PJ, Cai H, Daines DH, van den Anker JN, Gopalakrishnan M. Intergenerational transmission of sucralose and acesulfame-potassium from mothers to their infants via human milk: a pharmacokinetic study. Am J Clin Nutr. 2024 Oct;120(4):846-853. doi: 10.1016/j.ajcnut.2024.08.001. Epub 2024 Aug 5.
PubMed 39111550
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
- ClinicalTrials.gov ID
- NCT05379270
- Acronym / sponsor ID
- NCR213471
- Conditions
- Breastfeeding
- Keywords
- low-calorie sweeteners, sucralose, acesulfame-potassium, pharmacokinetics, breast milk, lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Posted 12 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low-calorie sweetener (LCS) consumption is highly prevalent among lactating women, yet the current understanding of LCS effects on diet, weight, and health is extremely limited, especially when exposure begins early in life. This project aims to measure the widely consumed LCSs, sucralose and acesulfame-potassium, in maternal breast milk and plasma, at pre-specified, time-points over the course of 72 hours, and in a single sample of infants' plasma (analyzed using a population pharmacokinetics approach).
Mothers will attend an enrollment visit, which will take place virtually and will schedule an in-person visit to take place at Children's National Hospital approximately one week later. During the enrollment visit, informed consent will be obtained and demographic, anthropometric, and dietary data will be collected. During the week prior to their scheduled in-person study visit, mothers will be instructed to continue their usual dietary habits and to complete an online, photo-assisted, 7-day food record.
Mothers will be instructed to arrive fasted for the in-person visit, which will last for approximately 13 hours. Following ingestion of a diet beverage containing sucralose and ace-K, mothers will remain at Children's National for supervised serial sample collection at pre-determined time points over 12 hours, and will provide additional samples on three subsequent consecutive days (72 hours). Mothers will be instructed to continue to complete the online, photo-assisted, food record for the three days following the in-person study visit (until 72 hours following diet beverage consumption).
A plasma sample will be collected from each infant via heel-stick at one of the following pre-specified time intervals following the mother's ingestion of the diet beverage: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, 9-14 hours, and 22-36 hours.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet soda | Experimental | Other: Diet sodaParticipants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
- active nutritional disorder known to cause malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet sodaParticipants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium. | Other | Diet soda |
Primary outcome
Baseline Sucralose Concentration in Breast Milk
Time frame: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of sucralose in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
1-hour Sucralose Concentration in Breast Milk
Time frame: 1 hour post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2-hour Sucralose Concentrations in Breast Milk
Time frame: 2 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3-hour Sucralose Concentrations in Breast Milk
Time frame: 3 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4-hour Sucralose Concentrations in Breast Milk
Time frame: 4 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6-hour Sucralose Concentrations in Breast Milk
Time frame: 6 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8-hour Sucralose Concentrations in Breast Milk
Time frame: 8 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12-hour Sucralose Concentrations in Breast Milk
Time frame: 12 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24-hour Sucralose Concentrations in Breast Milk
Time frame: 24 hours post-ingestion
Mean concentration of sucralose in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Acesulfame-potassium Concentrations in Breast Milk
Time frame: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
1-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 1 hour post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 2 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 3 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 4 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 6 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 8 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 12 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24-hour Acesulfame-potassium Concentrations in Breast Milk
Time frame: 24 hours post-ingestion
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Sucralose Concentration in Maternal Plasma
Time frame: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
30-min Sucralose Concentration in Maternal Plasma
Time frame: 30 minutes post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1 Hour Sucralose Concentration in Maternal Plasma
Time frame: 1 hour post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1.5 Hour Sucralose Concentration in Maternal Plasma
Time frame: 1.5 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2 Hour Sucralose Concentration in Maternal Plasma
Time frame: 2 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3 Hour Sucralose Concentration in Maternal Plasma
Time frame: 3 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4 Hour Sucralose Concentration in Maternal Plasma
Time frame: 4 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6 Hour Sucralose Concentration in Maternal Plasma
Time frame: 6 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8 Hour Sucralose Concentration in Maternal Plasma
Time frame: 8 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12 Hour Sucralose Concentration in Maternal Plasma
Time frame: 12 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24 Hour Sucralose Concentration in Maternal Plasma
Time frame: 24 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
48 Hour Sucralose Concentration in Maternal Plasma
Time frame: 48 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
72 Hour Sucralose Concentration in Maternal Plasma
Time frame: 72 hours post-ingestion
Mean concentration of sucralose in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Baseline Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: Day 0 (immediately prior to diet beverage ingestion)
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
30 Min Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 30 minutes post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 1 hour post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 1.5 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
2 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 2 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
3 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 3 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
4 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 4 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
6 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 6 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
8 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 8 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
12 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 12 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
24 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 24 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
48 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 48 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
72 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Time frame: 72 hours post-ingestion
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Sucralose Concentrations in Infant Plasma
Time frame: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Mean concentration of sucralose in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Acesulfame-potassium Concentrations in Infant Plasma
Time frame: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Mean concentration of acesulfame-potassium in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39111550Sylvetsky AC, Kuttamperoor JT, Langevin B, Murphy J, Arcaro KF, Smolyak S, Walter PJ, Cai H, Daines DH, van den Anker JN, Gopalakrishnan M. Intergenerational transmission of sucralose and acesulfame-potassium from mothers to their infants via human milk: a pharmacokinetic study. Am J Clin Nutr. 2024 Oct;120(4):846-853. doi: 10.1016/j.ajcnut.2024.08.001. Epub 2024 Aug 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet soda in people with Breastfeeding, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Sucralose Concentration in Breast Milk (time frame: Day 0 (immediately prior to diet beverage ingestion)). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05379270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.