Artificial Sweeteners in Breast Milk

Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective

This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Overweight; Breastfeeding
• Intervention / Treatment: Dietary supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Above 18 years old
• Able to give consent
• Able to produce enough amounts of breastmilk
• Danish/English speakers
• Pre-pregnancy BMI below 25 (20 subjects)
• Pre-pregnancy BMI above 27 (20 subjects)
• Diabetes type 1 or 2 (20 subjects)

Exclusion Criteria:

• Under the age of 18 years old
• Unable to give consent
• Unable to produce enough amounts of breastmilk
• Non-Danish/English speakers
• If they have consumed artificial sweeteners 24 hours prior to trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention groups; The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline	Dietary supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate); The intervention is found in light products ingested by millions of people on a daily basis worldwide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breastmilk from mother	Concentration of artificial sweeteners in mother's breast milk	Baseline, after 30 mins and afterwards once and hour for six hours
Blood from mother	Concentration of artificial sweeteners in mother's blood	Baseline, after 30 mins and afterwards once and hour for six hours

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Artificial sweeteners; Non-nutritive sweeteners
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: AS0063221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No