Pregnancy RelatedNCT03954418
Transport of Artificial Sweeteners During Pregnancy
A study testing Acesulfame K, cyclamate, saccharine, aspartame in people with Pregnancy Related and Diabetes, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Diabetes, IUGR
- What is being tested?
- Acesulfame K, cyclamate, saccharine, aspartame
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective caesarean section
- Child with IUGR (10 subjects)
- Diabetes (10 subjects)
- Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls)
Who cannot join
- Acute caesarean section
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners
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.
Read more
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
- Being tested
- Acesulfame K, cyclamate, saccharine, aspartame
- Keywords
- Artificial sweeteners, Non-nutritive sweeteners, Caesarean section
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acesulfame K, cyclamate, saccharine, aspartameDietary supplement
Also called Artificial sweeteners
Intervention group receives a combination of multiple artificial sweeteners
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will drink an artificially sweetened drink 2-4 hours before elective caesarean section. Receives: Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartame |
| Control group | No intervention | Participants in the control group will refrain from intake of artificial sweeteners. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mothers blood
Concentration of artificial sweeteners in blood from the mother
Measured: Time of birth
Placenta
Concentration of artificial sweeteners in placenta
Measured: Time of birth
Umbilical cord
Concentration of artificial sweeteners in blood from umbilical cord
Measured: Time of birth
Amniotic fluid
Concentration of artificial sweeteners in amniotic fluid
Measured: Time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jun 2019
- Primary completion1 Feb 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Ovesen, DMSc, Study director, per.ovesen@clin.au.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954418
- Sponsor's protocol ID
- MM_PO_MP_2019
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trans-placental Transport and Foetal Accumulation of Artificial Sweeteners
- ClinicalTrials.gov ID
- NCT03954418
- Acronym / sponsor ID
- MM_PO_MP_2019
- Conditions
- Pregnancy Related, Diabetes, IUGR
- Keywords
- Artificial sweeteners, Non-nutritive sweeteners, Caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Acesulfame K, cyclamate, saccharine, aspartameParticipants will drink an artificially sweetened drink 2-4 hours before elective caesarean section. |
| Control group | No intervention | –Participants in the control group will refrain from intake of artificial sweeteners. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective caesarean section
- Child with IUGR (10 subjects)
- Diabetes (10 subjects)
- Other reasons for caesarean section(10 healthy subjects in intervention + 10 healthy controls)
Key exclusion criteria (1 listed)
- Acute caesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acesulfame K, cyclamate, saccharine, aspartameAlso: Artificial sweetenersIntervention group receives a combination of multiple artificial sweeteners | Dietary supplement | Intervention group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ovesen, DMSc study director
per.ovesen@clin.au.dk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acesulfame K, cyclamate, saccharine, aspartame in people with Pregnancy Related and Diabetes, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mothers blood (time frame: Time of birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.