Transport of Artificial Sweeteners During Pregnancy

NCT03954418 | Completed

• 1 other identifier: MM_PO_MP_2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Diabetes; IUGR

Keywords

Artificial sweeteners; Non-nutritive sweeteners; Caesarean section

Outcome Measures

Primary Outcomes (4)

• Mothers blood

  Concentration of artificial sweeteners in blood from the mother

  Time of birth

• Placenta

  Concentration of artificial sweeteners in placenta

  Time of birth

• Umbilical cord

  Concentration of artificial sweeteners in blood from umbilical cord

  Time of birth

• Amniotic fluid

  Concentration of artificial sweeteners in amniotic fluid

  Time of birth

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section.

Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame

Control group

NO INTERVENTION

Participants in the control group will refrain from intake of artificial sweeteners.

Interventions

Acesulfame K, cyclamate, saccharine, aspartame DIETARY_SUPPLEMENT

Intervention group receives a combination of multiple artificial sweeteners

Also known as: Artificial sweeteners

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective caesarean section
• Child with IUGR (10 subjects)
• Diabetes (10 subjects)
• Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls)

You may not qualify if:

• Acute caesarean section

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Obstetrics and Gynecology

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

acetosulfame; Cyclamates; Aspartame; Sweetening Agents

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Flavoring Agents; Food Additives; Food Ingredients; Specialty Uses of Chemicals; Chemical Actions and Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Per Ovesen, DMSc

  per.ovesen@clin.au.dk

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We wish to conduct an interventional, open-label study in which 40 women undergoing planned caesarean section will be included. In the intervention-group divided between: 10 women with IUGR-child, 10 women with diabetes, 10 healthy women. We will use a control group of 10 healthy women who will refrain from intake. The participants will drink an artificially sweetened soft drink 2 to 4 hours before planned c-section.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: June 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: September 1, 2020
• Last Updated: February 24, 2021

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)