Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
- Conditions
- Breastfeeding
- Interventions
- Other: Diet soda
- Registration Number
- NCT05379270
- Lead Sponsor
- George Washington University
- 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 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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 41
- 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
- known allergy or contraindication to sucralose or acesulfame-potassium (infant or mother)
- active nutritional disorder known to cause malabsorption
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diet soda Diet soda Participants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
- Primary Outcome Measures
Name Time Method 2-hour sucralose concentrations in breast milk 2 hours after diet beverage ingestion Sucralose will be measured in breast milk
30-min sucralose concentration in maternal plasma 30 minutes after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
4-hour sucralose concentrations in breast milk 4 hours after diet beverage ingestion Sucralose will be measured in breast milk
1-hour acesulfame-potassium concentrations in breast milk 1 hour after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
2-hour acesulfame-potassium concentrations in breast milk 2 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
6-hour acesulfame-potassium concentrations in breast milk 6 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
3-hour sucralose concentrations in breast milk 3 hours after diet beverage ingestion Sucralose will be measured in breast milk
12-hour sucralose concentrations in breast milk 12 hours after diet beverage ingestion Sucralose will be measured in breast milk
24-hour sucralose concentrations in breast milk 24 hours after diet beverage ingestion Sucralose will be measured in breast milk
Baseline acesulfame-potassium concentrations in breast milk Baseline (prior to diet beverage ingestion) Acesulfame-potassium will be measured in breast milk
3-hour acesulfame-potassium concentrations in breast milk 3 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
24 hour sucralose concentration in maternal plasma 24 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
1-hour sucralose concentrations in breast milk 1 hour after diet beverage ingestion Sucralose will be measured in breast milk
24-hour acesulfame-potassium concentrations in breast milk 24 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
Baseline acesulfame-potassium concentrations in maternal plasma baseline (before diet beverage ingestion) Acesulfame-potassium will be measured in maternal plasma
1 hour acesulfame-potassium concentrations in maternal plasma 1 hour after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
1.5 hour acesulfame-potassium concentrations in maternal plasma 1.5 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
2 hour acesulfame-potassium concentrations in maternal plasma 2 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
6 hour acesulfame-potassium concentrations in maternal plasma 6 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
24 hour acesulfame-potassium concentrations in maternal plasma 24 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
72 hour acesulfame-potassium concentrations in maternal plasma 72 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
Baseline sucralose concentrations in breast milk baseline (pre-diet beverage) Sucralose will be measured in breast milk
6-hour sucralose concentrations in breast milk 6 hours after diet beverage ingestion Sucralose will be measured in breast milk
8-hour sucralose concentrations in breast milk 8 hours after diet beverage ingestion Sucralose will be measured in breast milk
4-hour acesulfame-potassium concentrations in breast milk 4 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
8-hour acesulfame-potassium concentrations in breast milk 8 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
12-hour acesulfame-potassium concentrations in breast milk 12 hours after diet beverage ingestion Acesulfame-potassium will be measured in breast milk
Baseline sucralose concentration in maternal plasma baseline (before diet beverage ingestion) Sucralose concentrations will be measured in maternal plasma
1.5 hour sucralose concentration in maternal plasma 1.5 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
4 hour sucralose concentration in maternal plasma 4 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
3 hour sucralose concentration in maternal plasma 3 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
12 hour sucralose concentration in maternal plasma 12 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
48 hour sucralose concentration in maternal plasma 48 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
30 min acesulfame-potassium concentrations in maternal plasma 30 minutes after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
4 hour acesulfame-potassium concentrations in maternal plasma 4 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
1 hour sucralose concentration in maternal plasma 1 hour after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
2 hour sucralose concentration in maternal plasma 2 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
6 hour sucralose concentration in maternal plasma 6 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
8 hour sucralose concentration in maternal plasma 8 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
72 hour sucralose concentration in maternal plasma 72 hours after diet beverage ingestion Sucralose concentrations will be measured in maternal plasma
3 hour acesulfame-potassium concentrations in maternal plasma 3 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
8 hour acesulfame-potassium concentrations in maternal plasma 8 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
12 hour acesulfame-potassium concentrations in maternal plasma 12 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
48 hour acesulfame-potassium concentrations in maternal plasma 48 hours after diet beverage ingestion Acesulfame-potassium will be measured in maternal plasma
Sucralose concentrations in infant plasma varies across infants Sucralose will be measured in infant plasma at a single timepoint following ingestion of the diet beverage
Acesulfame-potassium concentrations in infant plasma varies across infants Acesulfame-potassium will be measured in infant plasma at a single timepoint following ingestion of the diet beverage
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The George Washington University
🇺🇸Washington, District of Columbia, United States