Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

Breastfeeding Clinical Trial

Official title:

Intergenerational Transmission of Low-calorie Sweeteners Via Breast Milk

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05379270
• Other study ID #: NCR213471
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 41
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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

Locations

Country	Name	City	State
United States	The George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

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