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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pregnancy Related Diabetes IUGR | Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 35 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners |
| Actual Study Start Date : | June 1, 2019 |
| Actual Primary Completion Date : | February 1, 2020 |
| Actual Study Completion Date : | September 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention group
Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section.
|
Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame
Intervention group receives a combination of multiple artificial sweeteners
Other Name: Artificial sweeteners
|
|
No Intervention: Control group
Participants in the control group will refrain from intake of artificial sweeteners.
|
- Mothers blood [ Time Frame: Time of birth ]Concentration of artificial sweeteners in blood from the mother
- Placenta [ Time Frame: Time of birth ]Concentration of artificial sweeteners in placenta
- Umbilical cord [ Time Frame: Time of birth ]Concentration of artificial sweeteners in blood from umbilical cord
- Amniotic fluid [ Time Frame: Time of birth ]Concentration of artificial sweeteners in amniotic fluid
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
| Denmark | |
| Obstetrics and Gynecology | |
| Aarhus, Denmark, 8200 | |
| Study Director: | Per Ovesen, DMSc | per.ovesen@clin.au.dk |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 15, 2019 | ||||||
| First Posted Date ICMJE | May 17, 2019 | ||||||
| Last Update Posted Date | February 24, 2021 | ||||||
| Actual Study Start Date ICMJE | June 1, 2019 | ||||||
| Actual Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Transport of Artificial Sweeteners During Pregnancy | ||||||
| Official Title ICMJE | Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners | ||||||
| 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. |
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| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: 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. Primary Purpose: Basic Science |
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| Condition ICMJE |
|
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| Intervention ICMJE | Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame
Intervention group receives a combination of multiple artificial sweeteners
Other Name: Artificial sweeteners
|
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
35 | ||||||
| Original Estimated Enrollment ICMJE |
40 | ||||||
| Actual Study Completion Date ICMJE | September 1, 2020 | ||||||
| Actual Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Denmark | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03954418 | ||||||
| Other Study ID Numbers ICMJE | MM_PO_MP_2019 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Aarhus | ||||||
| Study Sponsor ICMJE | University of Aarhus | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
|
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| PRS Account | University of Aarhus | ||||||
| Verification Date | May 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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