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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
82
Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
The George Washington University
Washington D.C., District of Columbia, United States
Baseline Sucralose Concentration in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Time frame: Day 0 (immediately prior to diet beverage ingestion)
1-hour Sucralose Concentration in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 1 hour post-ingestion
2-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 2 hours post-ingestion
3-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 3 hours post-ingestion
4-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 4 hours post-ingestion
6-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 6 hours post-ingestion
8-hour Sucralose Concentrations in Breast Milk
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Mean concentration of sucralose in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 8 hours post-ingestion
12-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 12 hours post-ingestion
24-hour Sucralose Concentrations in Breast Milk
Mean concentration of sucralose in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 24 hours post-ingestion
Baseline Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Time frame: Day 0 (immediately prior to diet beverage ingestion)
1-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 1 hour post-ingestion
2-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 2 hours post-ingestion
3-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 3 hours post-ingestion
4-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 4 hours post-ingestion
6-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 6 hours post-ingestion
8-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 8 hours post-ingestion
12-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 12 hours post-ingestion
24-hour Acesulfame-potassium Concentrations in Breast Milk
Mean concentration of acesulfame-potassium in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 24 hours post-ingestion
Baseline Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Time frame: Day 0 (immediately prior to diet beverage ingestion)
30-min Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 30 minutes post-ingestion
1 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 1 hour post-ingestion
1.5 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 1.5 hours post-ingestion
2 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 2 hours post-ingestion
3 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 3 hours post-ingestion
4 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 4 hours post-ingestion
6 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 6 hours post-ingestion
8 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 8 hours post-ingestion
12 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 12 hours post-ingestion
24 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 24 hours post-ingestion
48 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 48 hours post-ingestion
72 Hour Sucralose Concentration in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 72 hours post-ingestion
Baseline Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium.
Time frame: Day 0 (immediately prior to diet beverage ingestion)
30 Min Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 30 minutes post-ingestion
1 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 1 hour post-ingestion
1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour and 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 1.5 hours post-ingestion
2 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 2 hours post-ingestion
3 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 3 hours post-ingestion
4 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 4 hours post-ingestion
6 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 6 hours post-ingestion
8 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 8 hours post-ingestion
12 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 12 hours post-ingestion
24 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 24 hours post-ingestion
48 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 48 hours post-ingestion
72 Hour Acesulfame-potassium Concentrations in Maternal Plasma
Mean concentration of acesulfame-potassium in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: 72 hours post-ingestion
Sucralose Concentrations in Infant Plasma
Mean concentration of sucralose in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.
Acesulfame-potassium Concentrations in Infant Plasma
Mean concentration of acesulfame-potassium in plasma collected from infants at a single time point following maternal ingestion of a diet beverage containing sucralose and acesulfame-potassium.
Time frame: At one of five prespecified intervals post maternal diet beverage ingestion: 1.5-3 hours, 3-5 hours, 5-7 hours, 7-9 hours, or 9-14 hours.