Artificial Sweeteners in Breast Milk

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04578431

Enrollment

Registered

2020-10-08

Start date

2020-11-01

Completion date

2021-10-01

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding, Diabetes Mellitus, Overweight

Keywords

Artificial sweeteners, Non-nutritive sweeteners

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTArtificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)

The intervention is found in light products ingested by millions of people on a daily basis worldwide

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

All participants are given the same intervention and are aware of this

Intervention model description

60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status. The groups are 1. Normal weight (BMI \< 25), 2. Over weight (BMI \> 27), 3. Diabetic

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026