Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

NCT05379270 | Completed Results

• 1 other identifier: NCR213471
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

low-calorie sweeteners; sucralose; acesulfame-potassium; pharmacokinetics; breast milk; lactation

Outcome Measures

Primary Outcomes (46)

• 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.

Study Arms (1)

Diet soda

EXPERIMENTAL

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

Other: Diet soda

Interventions

Diet soda OTHER

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

Diet soda

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
• active nutritional disorder known to cause malabsorption

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

The George Washington University

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

Location

Related Publications (1)

• 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.

  PMID: 39111550 DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Results Point of Contact

• Title: Allison Sylvetsky
• Organization: George Washington University

asylvets@gwu.edu

202-994-5602

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 18, 2022
• Study Start: February 28, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-10

Locations

US (1)