N/A
Completed N=82
Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
Source: ClinicalTrials.gov NCT05379270 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Baseline Sucralose Concentration in Breast Milk — 0.19 ng/ml
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Sucralose Concentration in Breast Milk |
0.19 | — |
| PRIMARY 1-hour Sucralose Concentration in Breast Milk |
0.48 | — |
| PRIMARY 2-hour Sucralose Concentrations in Breast Milk |
1.67 | — |
| PRIMARY 3-hour Sucralose Concentrations in Breast Milk |
3.23 | — |
| PRIMARY 4-hour Sucralose Concentrations in Breast Milk |
4.76 | — |
| PRIMARY 6-hour Sucralose Concentrations in Breast Milk |
6.61 | — |
| PRIMARY 8-hour Sucralose Concentrations in Breast Milk |
6.74 | — |
| PRIMARY 12-hour Sucralose Concentrations in Breast Milk |
5.18 | — |
| PRIMARY 24-hour Sucralose Concentrations in Breast Milk |
2.24 | — |
| PRIMARY Baseline Acesulfame-potassium Concentrations in Breast Milk |
18.11 | — |
| PRIMARY 1-hour Acesulfame-potassium Concentrations in Breast Milk |
115.27 | — |
| PRIMARY 2-hour Acesulfame-potassium Concentrations in Breast Milk |
294.22 | — |
| PRIMARY 3-hour Acesulfame-potassium Concentrations in Breast Milk |
380.65 | — |
| PRIMARY 4-hour Acesulfame-potassium Concentrations in Breast Milk |
405.75 | — |
| PRIMARY 6-hour Acesulfame-potassium Concentrations in Breast Milk |
323.14 | — |
| PRIMARY 8-hour Acesulfame-potassium Concentrations in Breast Milk |
205.91 | — |
| PRIMARY 12-hour Acesulfame-potassium Concentrations in Breast Milk |
81.01 | — |
| PRIMARY 24-hour Acesulfame-potassium Concentrations in Breast Milk |
28.17 | — |
| PRIMARY Baseline Sucralose Concentration in Maternal Plasma |
0.64 | — |
| PRIMARY 30-min Sucralose Concentration in Maternal Plasma |
38.03 | — |
| PRIMARY 1 Hour Sucralose Concentration in Maternal Plasma |
80.25 | — |
| PRIMARY 1.5 Hour Sucralose Concentration in Maternal Plasma |
90.45 | — |
| PRIMARY 2 Hour Sucralose Concentration in Maternal Plasma |
90.59 | — |
| PRIMARY 3 Hour Sucralose Concentration in Maternal Plasma |
75.85 | — |
| PRIMARY 4 Hour Sucralose Concentration in Maternal Plasma |
57.72 | — |
| PRIMARY 6 Hour Sucralose Concentration in Maternal Plasma |
31.28 | — |
| PRIMARY 8 Hour Sucralose Concentration in Maternal Plasma |
18.31 | — |
| PRIMARY 12 Hour Sucralose Concentration in Maternal Plasma |
8.31 | — |
| PRIMARY 24 Hour Sucralose Concentration in Maternal Plasma |
5.91 | — |
| PRIMARY 48 Hour Sucralose Concentration in Maternal Plasma |
3.61 | — |
| PRIMARY 72 Hour Sucralose Concentration in Maternal Plasma |
2.77 | — |
| PRIMARY Baseline Acesulfame-potassium Concentrations in Maternal Plasma |
3.93 | — |
| PRIMARY 30 Min Acesulfame-potassium Concentrations in Maternal Plasma |
192.2 | — |
| PRIMARY 1 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
308.98 | — |
| PRIMARY 1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
348.84 | — |
| PRIMARY 2 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
355.69 | — |
| PRIMARY 3 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
290.56 | — |
| PRIMARY 4 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
203.23 | — |
| PRIMARY 6 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
106.05 | — |
| PRIMARY 8 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
58.09 | — |
| PRIMARY 12 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
20.91 | — |
| PRIMARY 24 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
5.26 | — |
| PRIMARY 48 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
8.44 | — |
| PRIMARY 72 Hour Acesulfame-potassium Concentrations in Maternal Plasma |
8.16 | — |
| PRIMARY Sucralose Concentrations in Infant Plasma |
5.0 | — |
| PRIMARY Acesulfame-potassium Concentrations in Infant Plasma |
9.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05379270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.