Breastfeeding
Conditions
Keywords
low-calorie sweeteners, sucralose, acesulfame-potassium, pharmacokinetics, breast milk, lactation
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.
Interventions
OTHERDiet soda
Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Sponsors
George Washington University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4-hour Acesulfame-potassium Concentrations in Breast Milk | 4 hours post-ingestion | 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. |
| Baseline Sucralose Concentration in Breast Milk | Day 0 (immediately prior to diet beverage ingestion) | Mean concentration of sucralose in breast milk collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium. |
| 1-hour Sucralose Concentration in Breast Milk | 1 hour post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 2-hour Sucralose Concentrations in Breast Milk | 2 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 3-hour Sucralose Concentrations in Breast Milk | 3 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 4-hour Sucralose Concentrations in Breast Milk | 4 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 6-hour Sucralose Concentrations in Breast Milk | 6 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 8-hour Sucralose Concentrations in Breast Milk | 8 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 12-hour Sucralose Concentrations in Breast Milk | 12 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 24-hour Sucralose Concentrations in Breast Milk | 24 hours post-ingestion | Mean concentration of sucralose in breast milk collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| Baseline Acesulfame-potassium Concentrations in Breast Milk | Day 0 (immediately prior to diet beverage ingestion) | 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. |
| 1-hour Acesulfame-potassium Concentrations in Breast Milk | 1 hour post-ingestion | 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. |
| 2-hour Acesulfame-potassium Concentrations in Breast Milk | 2 hours post-ingestion | 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. |
| 3-hour Acesulfame-potassium Concentrations in Breast Milk | 3 hours post-ingestion | 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. |
| 6-hour Acesulfame-potassium Concentrations in Breast Milk | 6 hours post-ingestion | 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. |
| 8-hour Acesulfame-potassium Concentrations in Breast Milk | 8 hours post-ingestion | 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. |
| 12-hour Acesulfame-potassium Concentrations in Breast Milk | 12 hours post-ingestion | 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. |
| 24-hour Acesulfame-potassium Concentrations in Breast Milk | 24 hours post-ingestion | 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. |
| Baseline Sucralose Concentration in Maternal Plasma | Day 0 (immediately prior to diet beverage ingestion) | Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium. |
| 30-min Sucralose Concentration in Maternal Plasma | 30 minutes post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 1 Hour Sucralose Concentration in Maternal Plasma | 1 hour post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 1.5 Hour Sucralose Concentration in Maternal Plasma | 1.5 hours post-ingestion | 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. |
| 2 Hour Sucralose Concentration in Maternal Plasma | 2 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 3 Hour Sucralose Concentration in Maternal Plasma | 3 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 4 Hour Sucralose Concentration in Maternal Plasma | 4 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 6 Hour Sucralose Concentration in Maternal Plasma | 6 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 8 Hour Sucralose Concentration in Maternal Plasma | 8 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 12 Hour Sucralose Concentration in Maternal Plasma | 12 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 24 Hour Sucralose Concentration in Maternal Plasma | 24 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 48 Hour Sucralose Concentration in Maternal Plasma | 48 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 72 Hour Sucralose Concentration in Maternal Plasma | 72 hours post-ingestion | Mean concentration of sucralose in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| Baseline Acesulfame-potassium Concentrations in Maternal Plasma | Day 0 (immediately prior to diet beverage ingestion) | Mean concentration of sucralose in plasma collected from mothers measured immediately prior to ingestion of the diet beverage containing sucralose and acesulfame-potassium. |
| 30 Min Acesulfame-potassium Concentrations in Maternal Plasma | 30 minutes post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 1 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 1 hour post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 1 hour after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 1.5 hours post-ingestion | 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. |
| 2 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 2 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 2 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 3 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 3 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 3 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 4 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 4 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 4 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 6 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 6 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 6 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 8 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 8 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 8 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 12 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 12 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 12 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 24 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 24 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 24 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 48 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 48 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 48 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| 72 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 72 hours post-ingestion | Mean concentration of acesulfame-potassium in plasma collected from mothers measured 72 hours after ingestion of a diet beverage containing sucralose and acesulfame-potassium. |
| Sucralose Concentrations in Infant Plasma | 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. | 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. |
| Acesulfame-potassium Concentrations in Infant Plasma | 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. | 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. |
Countries
United States
Participant flow
Recruitment details
Mother-infant dyads are recruited between February 2022 and November 2022 at the George Washington University Medical Faculty Associates Obstetrics & Gynecology clinic, using the clinic-based mobile application Babyscripts, as well as through local social media and neighborhood listservs.
Pre-assignment details
Since this is a dyad study, enrollment is reported at the individual level. A total of 41 dyads (82 individuals: 41 mothers and 41 infants) consented, enrolled, and started. One dyad (2 individuals) withdrew prior to analysis, resulting in 40 dyads (80 individuals) with baseline and outcome data.
Participants by arm
| Arm | Count |
|---|---|
| Diet Beverage Exposure (Mother) Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium. | 40 |
| Diet Beverage Exposure (Infant) Infants in the dyad. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Diet Beverage Exposure (Mother) | Diet Beverage Exposure (Infant) | Total |
|---|---|---|---|
| Age, Continuous Age | 32.4 years, months STANDARD_DEVIATION 4.9 | 2.9 years, months STANDARD_DEVIATION 1.6 | 17.65 years, months STANDARD_DEVIATION 3.25 |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black | 12 Participants | 11 Participants | 23 Participants |
| Race/Ethnicity, Customized Race More than one race | 6 Participants | 9 Participants | 15 Participants |
| Race/Ethnicity, Customized Race White | 19 Participants | 17 Participants | 36 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Sex Female | 40 Participants | 22 Participants | 62 Participants |
| Sex: Female, Male Sex Male | 0 Participants | 18 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 12-hour Acesulfame-potassium Concentrations in Breast Milk | 81.01 ng/ml | Standard Deviation 59.62 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 12 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 20.91 ng/ml | Standard Deviation 6.44 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 12 Hour Sucralose Concentration in Maternal Plasma | 8.31 ng/ml | Standard Deviation 1.76 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 12-hour Sucralose Concentrations in Breast Milk | 5.18 ng/ml | Standard Deviation 2.37 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 348.84 ng/ml | Standard Deviation 102.77 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 1.5 Hour Sucralose Concentration in Maternal Plasma | 90.45 ng/ml | Standard Deviation 29.14 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 1-hour Acesulfame-potassium Concentrations in Breast Milk | 115.27 ng/ml | Standard Deviation 101.52 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 1 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 308.98 ng/ml | Standard Deviation 115.8 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 1-hour Sucralose Concentration in Breast Milk | 0.48 ng/ml | Standard Deviation 0.6 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 1 Hour Sucralose Concentration in Maternal Plasma | 80.25 ng/ml | Standard Deviation 25.86 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 24-hour Acesulfame-potassium Concentrations in Breast Milk | 28.17 ng/ml | Standard Deviation 122.52 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 24 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 5.26 ng/ml | Standard Deviation 17.2 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 24 Hour Sucralose Concentration in Maternal Plasma | 5.91 ng/ml | Standard Deviation 2.87 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 24-hour Sucralose Concentrations in Breast Milk | 2.24 ng/ml | Standard Deviation 1.28 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 2-hour Acesulfame-potassium Concentrations in Breast Milk | 294.22 ng/ml | Standard Deviation 285.44 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 2 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 355.69 ng/ml | Standard Deviation 95.86 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 2 Hour Sucralose Concentration in Maternal Plasma | 90.59 ng/ml | Standard Deviation 29.6 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 2-hour Sucralose Concentrations in Breast Milk | 1.67 ng/ml | Standard Deviation 0.98 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 30 Min Acesulfame-potassium Concentrations in Maternal Plasma | 192.2 ng/ml | Standard Deviation 80.38 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 30-min Sucralose Concentration in Maternal Plasma | 38.03 ng/ml | Standard Deviation 15.02 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 3-hour Acesulfame-potassium Concentrations in Breast Milk | 380.65 ng/ml | Standard Deviation 327.21 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 3 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 290.56 ng/ml | Standard Deviation 72.99 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 3 Hour Sucralose Concentration in Maternal Plasma | 75.85 ng/ml | Standard Deviation 28.45 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 3-hour Sucralose Concentrations in Breast Milk | 3.23 ng/ml | Standard Deviation 1.5 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 48 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 8.44 ng/ml | Standard Deviation 22.82 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 48 Hour Sucralose Concentration in Maternal Plasma | 3.61 ng/ml | Standard Deviation 2.3 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 4-hour Acesulfame-potassium Concentrations in Breast Milk | 405.75 ng/ml | Standard Deviation 287.77 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 4 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 203.23 ng/ml | Standard Deviation 56.42 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 4 Hour Sucralose Concentration in Maternal Plasma | 57.72 ng/ml | Standard Deviation 25.52 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 4-hour Sucralose Concentrations in Breast Milk | 4.76 ng/ml | Standard Deviation 1.99 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 6-hour Acesulfame-potassium Concentrations in Breast Milk | 323.14 ng/ml | Standard Deviation 216.9 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 6 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 106.05 ng/ml | Standard Deviation 39.44 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 6 Hour Sucralose Concentration in Maternal Plasma | 31.28 ng/ml | Standard Deviation 12.82 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 6-hour Sucralose Concentrations in Breast Milk | 6.61 ng/ml | Standard Deviation 2.81 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 72 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 8.16 ng/ml | Standard Deviation 15.72 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 72 Hour Sucralose Concentration in Maternal Plasma | 2.77 ng/ml | Standard Deviation 2.28 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 8-hour Acesulfame-potassium Concentrations in Breast Milk | 205.91 ng/ml | Standard Deviation 134.98 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 8 Hour Acesulfame-potassium Concentrations in Maternal Plasma | 58.09 ng/ml | Standard Deviation 26.41 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 8 Hour Sucralose Concentration in Maternal Plasma | 18.31 ng/ml | Standard Deviation 6.87 |
Primary
8-hour Sucralose Concentrations in Breast Milk
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | 8-hour Sucralose Concentrations in Breast Milk | 6.74 ng/ml | Standard Deviation 2.76 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | Acesulfame-potassium Concentrations in Infant Plasma | 9.2 ng/ml | Standard Deviation 14.8 |
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | Baseline Acesulfame-potassium Concentrations in Breast Milk | 18.11 ng/ml | Standard Deviation 49.04 |
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | Baseline Acesulfame-potassium Concentrations in Maternal Plasma | 3.93 ng/ml | Standard Deviation 11.62 |
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | Baseline Sucralose Concentration in Breast Milk | 0.19 ng/ml | Standard Deviation 0.57 |
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | Baseline Sucralose Concentration in Maternal Plasma | 0.64 ng/ml | Standard Deviation 1.7 |
Primary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diet Beverage Exposure (Mother) | Sucralose Concentrations in Infant Plasma | 5.0 ng/ml | Standard Deviation 7.1 |