Transport of Artificial Sweeteners During Pregnancy

Diabetes Clinical Trial

Official title:

Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03954418
• Other study ID #: MM_PO_MP_2019
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: May 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• IUGR
• Pregnancy Related

Intervention

Dietary Supplement:
• Acesulfame K, cyclamate, saccharine, aspartame
Intervention group receives a combination of multiple artificial sweeteners

Locations

Country	Name	City	State
Denmark	Obstetrics and Gynecology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mothers blood	Concentration of artificial sweeteners in blood from the mother	Time of birth
Primary	Placenta	Concentration of artificial sweeteners in placenta	Time of birth
Primary	Umbilical cord	Concentration of artificial sweeteners in blood from umbilical cord	Time of birth
Primary	Amniotic fluid	Concentration of artificial sweeteners in amniotic fluid	Time of birth