Status:
COMPLETED
Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
Lead Sponsor:
George Washington University
Conditions:
Breastfeeding
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
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 exposu...
Eligibility Criteria
Inclusion
- 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
- known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
- active nutritional disorder known to cause malabsorption
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT05379270
Start Date
February 28 2022
End Date
December 2 2022
Last Update
November 12 2025
Active Locations (1)
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1
The George Washington University
Washington D.C., District of Columbia, United States, 20052