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Completed

NCT Number: NCT05379270

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet Soda

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

  36. 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.

  37. 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.

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 18, 2022
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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