Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

Conditions
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Breastfeeding

Intervention / Treatment
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* Other: Diet soda


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet soda<br>Participants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium. | Other: Diet soda<br>* Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline sucralose concentrations in breast milk | Sucralose will be measured in breast milk | baseline (pre-diet beverage) | 
| 1-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 1 hour after diet beverage ingestion | 
| 2-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 2 hours after diet beverage ingestion | 
| 3-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 3 hours after diet beverage ingestion | 
| 4-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 4 hours after diet beverage ingestion | 
| 6-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 6 hours after diet beverage ingestion | 
| 8-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 8 hours after diet beverage ingestion | 
| 12-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 12 hours after diet beverage ingestion | 
| 24-hour sucralose concentrations in breast milk | Sucralose will be measured in breast milk | 24 hours after diet beverage ingestion | 
| Baseline acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | Baseline (prior to diet beverage ingestion) | 
| 1-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 1 hour after diet beverage ingestion | 
| 2-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 2 hours after diet beverage ingestion | 
| 3-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 3 hours after diet beverage ingestion | 
| 4-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 4 hours after diet beverage ingestion | 
| 6-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 6 hours after diet beverage ingestion | 
| 8-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 8 hours after diet beverage ingestion | 
| 12-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 12 hours after diet beverage ingestion | 
| 24-hour acesulfame-potassium concentrations in breast milk | Acesulfame-potassium will be measured in breast milk | 24 hours after diet beverage ingestion | 
| Baseline sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | baseline (before diet beverage ingestion) | 
| 30-min sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 30 minutes after diet beverage ingestion | 
| 1 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 1 hour after diet beverage ingestion | 
| 1.5 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 1.5 hours after diet beverage ingestion | 
| 2 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 2 hours after diet beverage ingestion | 
| 3 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 3 hours after diet beverage ingestion | 
| 4 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 4 hours after diet beverage ingestion | 
| 6 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 6 hours after diet beverage ingestion | 
| 8 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 8 hours after diet beverage ingestion | 
| 12 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 12 hours after diet beverage ingestion | 
| 24 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 24 hours after diet beverage ingestion | 
| 48 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 48 hours after diet beverage ingestion | 
| 72 hour sucralose concentration in maternal plasma | Sucralose concentrations will be measured in maternal plasma | 72 hours after diet beverage ingestion | 
| Baseline acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | baseline (before diet beverage ingestion) | 
| 30 min acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 30 minutes after diet beverage ingestion | 
| 1 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 1 hour after diet beverage ingestion | 
| 1.5 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 1.5 hours after diet beverage ingestion | 
| 2 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 2 hours after diet beverage ingestion | 
| 3 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 3 hours after diet beverage ingestion | 
| 4 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 4 hours after diet beverage ingestion | 
| 6 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 6 hours after diet beverage ingestion | 
| 8 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 8 hours after diet beverage ingestion | 
| 12 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 12 hours after diet beverage ingestion | 
| 24 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 24 hours after diet beverage ingestion | 
| 48 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 48 hours after diet beverage ingestion | 
| 72 hour acesulfame-potassium concentrations in maternal plasma | Acesulfame-potassium will be measured in maternal plasma | 72 hours after diet beverage ingestion | 
| Sucralose concentrations in infant plasma | Sucralose will be measured in infant plasma at a single timepoint following ingestion of the diet beverage | varies across infants | 
| Acesulfame-potassium concentrations in infant plasma | Acesulfame-potassium will be measured in infant plasma at a single timepoint following ingestion of the diet beverage | varies across infants | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low-calorie sweeteners, sucralose, acesulfame-potassium, pharmacokinetics, breast milk, lactation