Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

Sponsor

George Washington University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379270

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding	Other: Diet soda	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

Actual Study Start Date :

Feb 28, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diet soda Participants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.	Other: Diet soda Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.

Arm

Intervention/Treatment

Experimental: Diet soda

Participants will be asked to ingest 24 of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.

Other: Diet soda

Participants will be asked to drink 24 ounces of a commercially-available diet beverage sweetened with sucralose and acesulfame-potassium.

Outcome Measures

Primary Outcome Measures

Baseline sucralose concentrations in breast milk [baseline (pre-diet beverage)]
Sucralose will be measured in breast milk
1-hour sucralose concentrations in breast milk [1 hour after diet beverage ingestion]
Sucralose will be measured in breast milk
2-hour sucralose concentrations in breast milk [2 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
3-hour sucralose concentrations in breast milk [3 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
4-hour sucralose concentrations in breast milk [4 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
6-hour sucralose concentrations in breast milk [6 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
8-hour sucralose concentrations in breast milk [8 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
12-hour sucralose concentrations in breast milk [12 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
24-hour sucralose concentrations in breast milk [24 hours after diet beverage ingestion]
Sucralose will be measured in breast milk
Baseline acesulfame-potassium concentrations in breast milk [Baseline (prior to diet beverage ingestion)]
Acesulfame-potassium will be measured in breast milk
1-hour acesulfame-potassium concentrations in breast milk [1 hour after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
2-hour acesulfame-potassium concentrations in breast milk [2 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
3-hour acesulfame-potassium concentrations in breast milk [3 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
4-hour acesulfame-potassium concentrations in breast milk [4 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
6-hour acesulfame-potassium concentrations in breast milk [6 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
8-hour acesulfame-potassium concentrations in breast milk [8 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
12-hour acesulfame-potassium concentrations in breast milk [12 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
24-hour acesulfame-potassium concentrations in breast milk [24 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in breast milk
Baseline sucralose concentration in maternal plasma [baseline (before diet beverage ingestion)]
Sucralose concentrations will be measured in maternal plasma
30-min sucralose concentration in maternal plasma [30 minutes after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
1 hour sucralose concentration in maternal plasma [1 hour after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
1.5 hour sucralose concentration in maternal plasma [1.5 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
2 hour sucralose concentration in maternal plasma [2 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
3 hour sucralose concentration in maternal plasma [3 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
4 hour sucralose concentration in maternal plasma [4 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
6 hour sucralose concentration in maternal plasma [6 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
8 hour sucralose concentration in maternal plasma [8 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
12 hour sucralose concentration in maternal plasma [12 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
24 hour sucralose concentration in maternal plasma [24 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
48 hour sucralose concentration in maternal plasma [48 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
72 hour sucralose concentration in maternal plasma [72 hours after diet beverage ingestion]
Sucralose concentrations will be measured in maternal plasma
Baseline acesulfame-potassium concentrations in maternal plasma [baseline (before diet beverage ingestion)]
Acesulfame-potassium will be measured in maternal plasma
30 min acesulfame-potassium concentrations in maternal plasma [30 minutes after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
1 hour acesulfame-potassium concentrations in maternal plasma [1 hour after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
1.5 hour acesulfame-potassium concentrations in maternal plasma [1.5 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
2 hour acesulfame-potassium concentrations in maternal plasma [2 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
3 hour acesulfame-potassium concentrations in maternal plasma [3 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
4 hour acesulfame-potassium concentrations in maternal plasma [4 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
6 hour acesulfame-potassium concentrations in maternal plasma [6 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
8 hour acesulfame-potassium concentrations in maternal plasma [8 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
12 hour acesulfame-potassium concentrations in maternal plasma [12 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
24 hour acesulfame-potassium concentrations in maternal plasma [24 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
48 hour acesulfame-potassium concentrations in maternal plasma [48 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
72 hour acesulfame-potassium concentrations in maternal plasma [72 hours after diet beverage ingestion]
Acesulfame-potassium will be measured in maternal plasma
Sucralose concentrations in infant plasma [varies across infants]
Sucralose will be measured in infant plasma at a single timepoint following ingestion of the diet beverage
Acesulfame-potassium concentrations in infant plasma [varies across infants]
Acesulfame-potassium will be measured in infant plasma at a single timepoint following ingestion of the diet beverage

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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