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Diet Soda Impact on Breastfeeding

N/A

Waitlist Available

Research Sponsored by George Washington University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour after diet beverage ingestion

Awards & highlights

Study Summary

This trial will study the levels of two low-calorie sweeteners, sucralose and acesulfame-potassium, in the breast milk and plasma of mothers and their infants. Samples will be taken at various intervals over a 72 hour period. The data collected will help inform future studies on the potential consequences of LCS exposure during early life.

Who is the study for?

This trial is for mothers over 18 who gave birth within the last 6 months and are exclusively breastfeeding infants at least 4 weeks old. Participants should regularly consume low-calorie sweetener drinks. Those with allergies to sucralose or acesulfame-potassium, or have malabsorption disorders, cannot join.Check my eligibility

What is being tested?

The study measures levels of low-calorie sweeteners, specifically sucralose and acesulfame-potassium, in breast milk and blood of mothers and their babies' blood after consuming diet soda. The process uses advanced testing called LC-MS over three days to gather data.See study design

What are the potential side effects?

Since this trial involves dietary intake rather than medication, traditional side effects are not expected. However, there may be unknown risks associated with exposure to these sweeteners in infants that the study aims to uncover.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-diet beverage)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-diet beverage)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-diet beverage) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

1 hour acesulfame-potassium concentrations in maternal plasma

1 hour sucralose concentration in maternal plasma

1-hour acesulfame-potassium concentrations in breast milk

+43 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diet sodaExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

George Washington UniversityLead Sponsor

243 Previous Clinical Trials

453,733 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this experiment currently available for participants?

"As per the clinicaltrials.gov listing, this study is currently in its recruitment phase for participants. It was initially posted on February 28th 2022 with an update made most recently on May 17th 2022."

Answered by AI

How many individuals are being invited to participate in this research endeavor?

"That is correct. Information hosted on clinicaltrials.gov suggests that this research study, which was initially published on February 28th 2022, is actively seeking participants. 40 individuals are needed to be recruited from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

2022. "Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05379270.