Artificial Sweeteners in Breast Milk

Not Applicable

Completed

• Conditions: Breastfeeding; Diabetes Mellitus; Overweight
• Interventions: Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)

• Registration Number: NCT04578431
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2020-11-01
• Primary Completion: 2021-07-01
• Study Completion: 2021-10-01
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention groups	Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)	The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark