Diet soda for Breast Feeding

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The George Washington University, Washington, United States
Breast Feeding
Diet soda - Other
Eligibility
18+
Female
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Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

46 Primary · 0 Secondary · Reporting Duration: 30 minutes after diet beverage ingestion

Hour 1
1 hour acesulfame-potassium concentrations in maternal plasma
1 hour sucralose concentration in maternal plasma
1-hour acesulfame-potassium concentrations in breast milk
1-hour sucralose concentrations in breast milk
Hour 5
1.5 hour acesulfame-potassium concentrations in maternal plasma
1.5 hour sucralose concentration in maternal plasma
Hour 12
12 hour acesulfame-potassium concentrations in maternal plasma
12 hour sucralose concentration in maternal plasma
12-hour acesulfame-potassium concentrations in breast milk
12-hour sucralose concentrations in breast milk
Hour 2
2 hour acesulfame-potassium concentrations in maternal plasma
2 hour sucralose concentration in maternal plasma
2-hour acesulfame-potassium concentrations in breast milk
2-hour sucralose concentrations in breast milk
Hour 24
24 hour acesulfame-potassium concentrations in maternal plasma
24 hour sucralose concentration in maternal plasma
24-hour acesulfame-potassium concentrations in breast milk
24-hour sucralose concentrations in breast milk
Hour 3
3 hour acesulfame-potassium concentrations in maternal plasma
3 hour sucralose concentration in maternal plasma
3-hour acesulfame-potassium concentrations in breast milk
3-hour sucralose concentrations in breast milk
30 minutes after diet beverage ingestion
30 min acesulfame-potassium concentrations in maternal plasma
30-min sucralose concentration in maternal plasma
Hour 4
4 hour acesulfame-potassium concentrations in maternal plasma
4 hour sucralose concentration in maternal plasma
4-hour acesulfame-potassium concentrations in breast milk
4-hour sucralose concentrations in breast milk
Hour 48
48 hour acesulfame-potassium concentrations in maternal plasma
48 hour sucralose concentration in maternal plasma
Hour 6
6 hour acesulfame-potassium concentrations in maternal plasma
6 hour sucralose concentration in maternal plasma
6-hour acesulfame-potassium concentrations in breast milk
6-hour sucralose concentrations in breast milk
Hour 72
72 hour acesulfame-potassium concentrations in maternal plasma
72 hour sucralose concentration in maternal plasma
Hour 8
8 hour acesulfame-potassium concentrations in maternal plasma
8 hour sucralose concentration in maternal plasma
8-hour acesulfame-potassium concentrations in breast milk
8-hour sucralose concentrations in breast milk
Baseline (prior to diet beverage ingestion)
Baseline acesulfame-potassium concentrations in breast milk
baseline (before diet beverage ingestion)
Baseline acesulfame-potassium concentrations in maternal plasma
Baseline sucralose concentration in maternal plasma
baseline (pre-diet beverage)
Baseline sucralose concentrations in breast milk
varies across infants
Acesulfame-potassium concentrations in infant plasma
Sucralose concentrations in infant plasma

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Diet soda
1 of 1
Experimental Treatment

40 Total Participants · 1 Treatment Group

Primary Treatment: Diet soda · No Placebo Group · N/A

Diet soda
Other
Experimental Group · 1 Intervention: Diet soda · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes after diet beverage ingestion
Closest Location: The George Washington University · Washington, United States
Photo of washington 1Photo of washington 2Photo of washington 3
2018First Recorded Clinical Trial
1 TrialsResearching Breast Feeding
15 CompletedClinical Trials

Who is running the clinical trial?

George Washington UniversityLead Sponsor
197 Previous Clinical Trials
110,804 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Breastfeeding is the only way to get vitamin D.
You consume diet, low-calorie sweetener-containing beverages ≥ 1 time per week.
You have infants' corrected age ≥ 4 weeks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.