Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: Diet soda

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • The George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diet soda; Participants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.	Other: Diet soda; Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.

Collaborators and Investigators

• Sponsor: George Washington University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): December 2, 2022
• Study Completion (Actual): December 2, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: pharmacokinetics; lactation; breast milk; sucralose; low-calorie sweeteners; acesulfame-potassium
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: NCR213471

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No