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Completed

NCT Number: NCT03954418

Transport of Artificial Sweeteners During Pregnancy

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.

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Key information

Conditions

Pregnancy Related Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders IUGR Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Obstetrics and Gynecology

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acesulfame K, cyclamate, saccharine, aspartame

Dietary Supplement

Intervention group receives a combination of multiple artificial sweeteners

Other names: Artificial sweeteners

Primary outcomes

  1. Mothers blood

    Time frame: Time of birth

    Concentration of artificial sweeteners in blood from the mother

  2. Placenta

    Time frame: Time of birth

    Concentration of artificial sweeteners in placenta

  3. Umbilical cord

    Time frame: Time of birth

    Concentration of artificial sweeteners in blood from umbilical cord

  4. Amniotic fluid

    Time frame: Time of birth

    Concentration of artificial sweeteners in amniotic fluid

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 17, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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