Artificial Sweeteners in Breast Milk

Study Overview
=================
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.

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

Conditions
-----------------
Breastfeeding, Diabetes Mellitus, Overweight

Intervention / Treatment
-----------------
* Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Artificial sweeteners, Non-nutritive sweeteners