Back to resultsArtificial Sweeteners in Breast Milk
Primary Purpose
Breastfeeding, Diabetes Mellitus, Overweight
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)
Sponsored by
About this trial
This is an interventional basic science trial for Breastfeeding focused on measuring Artificial sweeteners, Non-nutritive sweeteners
Eligibility Criteria
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
Sites / Locations
- Aarhus University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention groups
Arm Description
The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline
Outcomes
Primary Outcome Measures
Breastmilk from mother
Concentration of artificial sweeteners in mother's breast milk
Blood from mother
Concentration of artificial sweeteners in mother's blood
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04578431
Brief Title
Artificial Sweeteners in Breast Milk
Official Title
Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Diabetes Mellitus, Overweight
Keywords
Artificial sweeteners, Non-nutritive sweeteners
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status.
The groups are
Normal weight (BMI < 25),
Over weight (BMI > 27),
Diabetic
Masking
None (Open Label)
Masking Description
All participants are given the same intervention and are aware of this
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention groups
Arm Type
Experimental
Arm Description
The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline
Intervention Type
Dietary Supplement
Intervention Name(s)
Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)
Intervention Description
The intervention is found in light products ingested by millions of people on a daily basis worldwide
Primary Outcome Measure Information:
Title
Breastmilk from mother
Description
Concentration of artificial sweeteners in mother's breast milk
Time Frame
Baseline, after 30 mins and afterwards once and hour for six hours
Title
Blood from mother
Description
Concentration of artificial sweeteners in mother's blood
Time Frame
Baseline, after 30 mins and afterwards once and hour for six hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Artificial Sweeteners in Breast Milk
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