Artificial Sweeteners in Breast Milk

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04578431
• Other study ID #: AS0063221
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding
• Diabetes Mellitus
• Overweight

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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