Transport of Artificial Sweeteners During Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Related; Diabetes; IUGR
• Interventions: Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame

• Registration Number: NCT03954418
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-06-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-09-01
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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)

Read More

Exclusion Criteria

• Acute caesarean section

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Acesulfame K, cyclamate, saccharine, aspartame	Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section.

Primary Outcome Measures

Name	Time	Method
Mothers blood	Time of birth	Concentration of artificial sweeteners in blood from the mother
Placenta	Time of birth	Concentration of artificial sweeteners in placenta
Umbilical cord	Time of birth	Concentration of artificial sweeteners in blood from umbilical cord
Amniotic fluid	Time of birth	Concentration of artificial sweeteners in amniotic fluid

Trial Locations

Locations (1)

Obstetrics and Gynecology; 🇩🇰 Aarhus, Denmark