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Transport of Artificial Sweeteners During Pregnancy

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University of Aarhus

Status

Completed

Conditions

Diabetes
IUGR
Pregnancy Related

Treatments

Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame

Study type

Interventional

Funder types

Other

Identifiers

NCT03954418
MM_PO_MP_2019

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Intervention group
Experimental group
Description:
Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section.
Treatment:
Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame
Control group
No Intervention group
Description:
Participants in the control group will refrain from intake of artificial sweeteners.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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