Clinical trial NCT05379270: Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
Official title: Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: low-calorie sweeteners
sucralose
acesulfame-potassium
pharmacokinetics
breast milk
lactation
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline sucralose concentrations in breast milk
timeFrame: baseline (pre-diet beverage)
measure: 1-hour sucralose concentrations in breast milk
timeFrame: 1 hour after diet beverage ingestion
measure: 2-hour sucralose concentrations in breast milk
timeFrame: 2 hours after diet beverage ingestion
measure: 3-hour sucralose concentrations in breast milk
timeFrame: 3 hours after diet beverage ingestion
measure: 4-hour sucralose concentrations in breast milk
timeFrame: 4 hours after diet beverage ingestion
measure: 6-hour sucralose concentrations in breast milk
timeFrame: 6 hours after diet beverage ingestion
measure: 8-hour sucralose concentrations in breast milk
timeFrame: 8 hours after diet beverage ingestion
measure: 12-hour sucralose concentrations in breast milk
timeFrame: 12 hours after diet beverage ingestion
measure: 24-hour sucralose concentrations in breast milk
timeFrame: 24 hours after diet beverage ingestion
measure: Baseline acesulfame-potassium concentrations in breast milk
timeFrame: Baseline (prior to diet beverage ingestion)
measure: 1-hour acesulfame-potassium concentrations in breast milk
timeFrame: 1 hour after diet beverage ingestion
measure: 2-hour acesulfame-potassium concentrations in breast milk
timeFrame: 2 hours after diet beverage ingestion
measure: 3-hour acesulfame-potassium concentrations in breast milk
timeFrame: 3 hours after diet beverage ingestion
measure: 4-hour acesulfame-potassium concentrations in breast milk
timeFrame: 4 hours after diet beverage ingestion
measure: 6-hour acesulfame-potassium concentrations in breast milk
timeFrame: 6 hours after diet beverage ingestion
measure: 8-hour acesulfame-potassium concentrations in breast milk
timeFrame: 8 hours after diet beverage ingestion
measure: 12-hour acesulfame-potassium concentrations in breast milk
timeFrame: 12 hours after diet beverage ingestion
measure: 24-hour acesulfame-potassium concentrations in breast milk
timeFrame: 24 hours after diet beverage ingestion
measure: Baseline sucralose concentration in maternal plasma
timeFrame: baseline (before diet beverage ingestion)
measure: 30-min sucralose concentration in maternal plasma
timeFrame: 30 minutes after diet beverage ingestion
measure: 1 hour sucralose concentration in maternal plasma
timeFrame: 1 hour after diet beverage ingestion
measure: 1.5 hour sucralose concentration in maternal plasma
timeFrame: 1.5 hours after diet beverage ingestion
measure: 2 hour sucralose concentration in maternal plasma
timeFrame: 2 hours after diet beverage ingestion
measure: 3 hour sucralose concentration in maternal plasma
timeFrame: 3 hours after diet beverage ingestion
measure: 4 hour sucralose concentration in maternal plasma
timeFrame: 4 hours after diet beverage ingestion
measure: 6 hour sucralose concentration in maternal plasma
timeFrame: 6 hours after diet beverage ingestion
measure: 8 hour sucralose concentration in maternal plasma
timeFrame: 8 hours after diet beverage ingestion
measure: 12 hour sucralose concentration in maternal plasma
timeFrame: 12 hours after diet beverage ingestion
measure: 24 hour sucralose concentration in maternal plasma
timeFrame: 24 hours after diet beverage ingestion
measure: 48 hour sucralose concentration in maternal plasma
timeFrame: 48 hours after diet beverage ingestion
measure: 72 hour sucralose concentration in maternal plasma
timeFrame: 72 hours after diet beverage ingestion
measure: Baseline acesulfame-potassium concentrations in maternal plasma
timeFrame: baseline (before diet beverage ingestion)
measure: 30 min acesulfame-potassium concentrations in maternal plasma
timeFrame: 30 minutes after diet beverage ingestion
measure: 1 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 1 hour after diet beverage ingestion
measure: 1.5 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 1.5 hours after diet beverage ingestion
measure: 2 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 2 hours after diet beverage ingestion
measure: 3 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 3 hours after diet beverage ingestion
measure: 4 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 4 hours after diet beverage ingestion
measure: 6 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 6 hours after diet beverage ingestion
measure: 8 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 8 hours after diet beverage ingestion
measure: 12 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 12 hours after diet beverage ingestion
measure: 24 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 24 hours after diet beverage ingestion
measure: 48 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 48 hours after diet beverage ingestion
measure: 72 hour acesulfame-potassium concentrations in maternal plasma
timeFrame: 72 hours after diet beverage ingestion
measure: Sucralose concentrations in infant plasma
timeFrame: varies across infants
measure: Acesulfame-potassium concentrations in infant plasma
timeFrame: varies across infants
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
Study officials:
References: