Transport of Artificial Sweeteners During Pregnancy

Study Overview
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Brief Summary
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With obesity on the rise worldwide more and more young women are also affected, leading to a higher prevalence of obese pregnant women and pregnant women with diabetes. Children of these women are in risk of developing obesity during childhood which again leads to overweight during adult life resulting in life-style related diseases such as diabetes and cardio-vascular disease. Overweight and diabetic women are currently advised to substitute sugar sweetened beverages with artificially sweetened beverages to lower caloric intake and avoid fluctuations in blood glucose to avoid complications during pregnancy for both mother and child. Recent studies suggest that high intake of artificial sweeteners during pregnancy increases the risk of the child developing obesity. If this is indeed true, the current guidelines have the opposite of the wanted and children already in risk of overweight are exposed to extra risk. To investigate if artificial sweeteners can affect the foetus, the investigators wish to examine whether artificial sweeteners can cross the placenta. The study is a clinical trial in which 40 women will be enrolled. 30 participants will drink a diet soft drink 2 hours before a caesarean section and 10 controls will refrain from intake. After birth the investigators will obtain a blood sample from the mother and from the umbilical cord and a placental biopsy and measure the contents of artificial sweeteners. Furthermore, the investigators will obtain a sample of amniotic fluid to examine if the sweeteners are excreted into the amniotic fluid. The results ultimately have the potential to change the current guidelines on diet for overweight and diabetic women during pregnancy.

Official Title
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Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners

Conditions
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Pregnancy Related, Diabetes, IUGR

Intervention / Treatment
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* Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective caesarean section Child with IUGR (10 subjects) Diabetes (10 subjects) Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls) Exclusion Criteria: Acute caesarean section

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: We wish to conduct an interventional, open-label study in which 40 women undergoing planned caesarean section will be included. In the intervention-group divided between: 10 women with IUGR-child, 10 women with diabetes, 10 healthy women. We will use a control group of 10 healthy women who will refrain from intake. The participants will drink an artificially sweetened soft drink 2 to 4 hours before planned c-section.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section. | Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame<br>* Intervention group receives a combination of multiple artificial sweeteners<br>* Other names: Artificial sweeteners;|
| No Intervention: Control group<br>Participants in the control group will refrain from intake of artificial sweeteners. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mothers blood | Concentration of artificial sweeteners in blood from the mother | Time of birth | 
| Placenta | Concentration of artificial sweeteners in placenta | Time of birth | 
| Umbilical cord | Concentration of artificial sweeteners in blood from umbilical cord | Time of birth | 
| Amniotic fluid | Concentration of artificial sweeteners in amniotic fluid | Time of birth | 

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