NCT03954418

Transport of Artificial Sweeteners During Pregnancy

Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Pregnancy Related
• Diabetes
• IUGR

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Acesulfame K, cyclamate, saccharine, aspartame	Intervention group receives a combination of multiple artificial sweeteners

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-02-01
• Completion: 2020-09-01
• First posted: 2019-05-17
• Last updated: 2021-02-24

Locations

1 site across 1 country: Denmark