Trial Outcomes & Findings for Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk (NCT NCT05379270)

NCT ID: NCT05379270

Last Updated: 2025-11-12

Results Overview

Mean concentration of sucralose in plasma collected from mothers measured 30 minutes after ingestion of a diet beverage containing sucralose and acesulfame-potassium.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 82 participants
• Primary outcome timeframe: 30 minutes post-ingestion
• Results posted on: 2025-11-12

Participant Flow

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.

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.

Participant milestones

Measure	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.	Diet Beverage Exposure (Infant) Infants in the dyad.
Overall Study STARTED	41	41
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	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.	Diet Beverage Exposure (Infant) Infants in the dyad.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

The columns presented separately report age for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.

Baseline characteristics by cohort

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.	Diet Beverage Exposure (Infant) n=40 Participants Infants in the dyad.	Total n=80 Participants Total of all reporting groups
Age, Continuous Age	32.4 years, months STANDARD_DEVIATION 4.9 • n=40 Participants • The columns presented separately report age for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.	2.9 years, months STANDARD_DEVIATION 1.6 • n=40 Participants • The columns presented separately report age for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.	17.65 years, months STANDARD_DEVIATION 3.25 • n=80 Participants • The columns presented separately report age for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.
Sex: Female, Male Sex · Female	40 Participants n=40 Participants • The column presented separately report sex for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.	22 Participants n=40 Participants • The column presented separately report sex for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.	62 Participants n=80 Participants • The column presented separately report sex for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.
Sex: Female, Male Sex · Male	0 Participants n=40 Participants • The column presented separately report sex for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.	18 Participants n=40 Participants • The column presented separately report sex for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.	18 Participants n=80 Participants • The column presented separately report sex for mothers (n=40) and infants (n=40), each subgroup representing half of the total participants. Therefore, the number analyzed in each column differs from the overall total to reflect the specific subgroup for which the measure applies.
Race/Ethnicity, Customized Race · White	19 Participants n=40 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	17 Participants n=38 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	36 Participants n=78 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.
Race/Ethnicity, Customized Race · Black	12 Participants n=40 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	11 Participants n=38 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	23 Participants n=78 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.
Race/Ethnicity, Customized Race · Asian	2 Participants n=40 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	0 Participants n=38 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	2 Participants n=78 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.
Race/Ethnicity, Customized Race · American Indian or Alaskan Native	1 Participants n=40 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	1 Participants n=38 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	2 Participants n=78 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.
Race/Ethnicity, Customized Race · More than one race	6 Participants n=40 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	9 Participants n=38 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.	15 Participants n=78 Participants • The column display race separately for mothers (n=40) and infants (n=38), with each subgroup representing participants within the dyads. The differing numbers analyzed in each column reflect the specific subgroup relevant to the measure. The lower infant count is due to two mothers choosing not to report their infant's race and/or ethnicity.
Region of Enrollment United States	40 participants n=40 Participants	40 participants n=40 Participants	80 participants n=80 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Baseline Sucralose Concentration in Breast Milk	0.19 ng/ml Standard Deviation 0.57

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
1-hour Sucralose Concentration in Breast Milk	0.48 ng/ml Standard Deviation 0.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
2-hour Sucralose Concentrations in Breast Milk	1.67 ng/ml Standard Deviation 0.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
3-hour Sucralose Concentrations in Breast Milk	3.23 ng/ml Standard Deviation 1.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
4-hour Sucralose Concentrations in Breast Milk	4.76 ng/ml Standard Deviation 1.99

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
6-hour Sucralose Concentrations in Breast Milk	6.61 ng/ml Standard Deviation 2.81

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
8-hour Sucralose Concentrations in Breast Milk	6.74 ng/ml Standard Deviation 2.76

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
12-hour Sucralose Concentrations in Breast Milk	5.18 ng/ml Standard Deviation 2.37

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
24-hour Sucralose Concentrations in Breast Milk	2.24 ng/ml Standard Deviation 1.28

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Baseline Acesulfame-potassium Concentrations in Breast Milk	18.11 ng/ml Standard Deviation 49.04

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
1-hour Acesulfame-potassium Concentrations in Breast Milk	115.27 ng/ml Standard Deviation 101.52

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
2-hour Acesulfame-potassium Concentrations in Breast Milk	294.22 ng/ml Standard Deviation 285.44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
3-hour Acesulfame-potassium Concentrations in Breast Milk	380.65 ng/ml Standard Deviation 327.21

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
4-hour Acesulfame-potassium Concentrations in Breast Milk	405.75 ng/ml Standard Deviation 287.77

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
6-hour Acesulfame-potassium Concentrations in Breast Milk	323.14 ng/ml Standard Deviation 216.90

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
8-hour Acesulfame-potassium Concentrations in Breast Milk	205.91 ng/ml Standard Deviation 134.98

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
12-hour Acesulfame-potassium Concentrations in Breast Milk	81.01 ng/ml Standard Deviation 59.62

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
24-hour Acesulfame-potassium Concentrations in Breast Milk	28.17 ng/ml Standard Deviation 122.52

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Baseline Sucralose Concentration in Maternal Plasma	0.64 ng/ml Standard Deviation 1.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
30-min Sucralose Concentration in Maternal Plasma	38.03 ng/ml Standard Deviation 15.02

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
1 Hour Sucralose Concentration in Maternal Plasma	80.25 ng/ml Standard Deviation 25.86

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
1.5 Hour Sucralose Concentration in Maternal Plasma	90.45 ng/ml Standard Deviation 29.14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
2 Hour Sucralose Concentration in Maternal Plasma	90.59 ng/ml Standard Deviation 29.6

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
3 Hour Sucralose Concentration in Maternal Plasma	75.85 ng/ml Standard Deviation 28.45

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
4 Hour Sucralose Concentration in Maternal Plasma	57.72 ng/ml Standard Deviation 25.52

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
6 Hour Sucralose Concentration in Maternal Plasma	31.28 ng/ml Standard Deviation 12.82

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
8 Hour Sucralose Concentration in Maternal Plasma	18.31 ng/ml Standard Deviation 6.87

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
12 Hour Sucralose Concentration in Maternal Plasma	8.31 ng/ml Standard Deviation 1.76

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
24 Hour Sucralose Concentration in Maternal Plasma	5.91 ng/ml Standard Deviation 2.87

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
48 Hour Sucralose Concentration in Maternal Plasma	3.61 ng/ml Standard Deviation 2.30

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
72 Hour Sucralose Concentration in Maternal Plasma	2.77 ng/ml Standard Deviation 2.28

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Baseline Acesulfame-potassium Concentrations in Maternal Plasma	3.93 ng/ml Standard Deviation 11.62

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
30 Min Acesulfame-potassium Concentrations in Maternal Plasma	192.2 ng/ml Standard Deviation 80.38

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
1 Hour Acesulfame-potassium Concentrations in Maternal Plasma	308.98 ng/ml Standard Deviation 115.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
1.5 Hour Acesulfame-potassium Concentrations in Maternal Plasma	348.84 ng/ml Standard Deviation 102.77

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
2 Hour Acesulfame-potassium Concentrations in Maternal Plasma	355.69 ng/ml Standard Deviation 95.86

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
3 Hour Acesulfame-potassium Concentrations in Maternal Plasma	290.56 ng/ml Standard Deviation 72.99

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
4 Hour Acesulfame-potassium Concentrations in Maternal Plasma	203.23 ng/ml Standard Deviation 56.42

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
6 Hour Acesulfame-potassium Concentrations in Maternal Plasma	106.05 ng/ml Standard Deviation 39.44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
8 Hour Acesulfame-potassium Concentrations in Maternal Plasma	58.09 ng/ml Standard Deviation 26.41

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
12 Hour Acesulfame-potassium Concentrations in Maternal Plasma	20.91 ng/ml Standard Deviation 6.44

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
24 Hour Acesulfame-potassium Concentrations in Maternal Plasma	5.26 ng/ml Standard Deviation 17.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
48 Hour Acesulfame-potassium Concentrations in Maternal Plasma	8.44 ng/ml Standard Deviation 22.82

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
72 Hour Acesulfame-potassium Concentrations in Maternal Plasma	8.16 ng/ml Standard Deviation 15.72

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Sucralose Concentrations in Infant Plasma	5.0 ng/ml Standard Deviation 7.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Diet Beverage Exposure (Mother) n=40 Participants Mothers in the dyad were asked to ingest 20 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.
Acesulfame-potassium Concentrations in Infant Plasma	9.2 ng/ml Standard Deviation 14.8

Adverse Events

Diet Beverage Exposure (Mother-Infant Dyads)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Allison Sylvetsky

George Washington University

Phone: 202-994-5602

Email: asylvets@gwu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place