BreastfeedingNCT04578431
Artificial Sweeteners in Breast Milk
A study testing Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate) in people with Breastfeeding and Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Diabetes Mellitus, Overweight
- What is being tested?
- Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 1 Oct 2021
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Above 18 years old
- Able to give consent
- Able to produce enough amounts of breastmilk
- Danish/English speakers
- Pre-pregnancy BMI below 25 (20 subjects)
- Pre-pregnancy BMI above 27 (20 subjects)
- Diabetes type 1 or 2 (20 subjects)
Who cannot join
- Under the age of 18 years old
- Unable to give consent
- Unable to produce enough amounts of breastmilk
- Non-Danish/English speakers
- If they have consumed artificial sweeteners 24 hours prior to trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective
This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.
- Conditions
- Breastfeeding, Diabetes Mellitus, Overweight
- Being tested
- Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)
- Keywords
- Artificial sweeteners, Non-nutritive sweeteners
- Medical subject headings
- Breast Feeding, Diabetes Mellitus, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)Dietary supplement
The intervention is found in light products ingested by millions of people on a daily basis worldwide
| Study group | Role | What they receive |
|---|---|---|
| Intervention groups | Experimental | The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline Receives: Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastmilk from mother
Concentration of artificial sweeteners in mother's breast milk
Measured: Baseline, after 30 mins and afterwards once and hour for six hours
Blood from mother
Concentration of artificial sweeteners in mother's blood
Measured: Baseline, after 30 mins and afterwards once and hour for six hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Nov 2020
- Primary completion1 Jul 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- 60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status. The groups are 1. Normal weight (BMI \< 25), 2. Over weight (BMI \> 27), 3. Diabetic
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578431
- Sponsor's protocol ID
- AS0063221
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Sweeteners in Breast Milk: A Clinical Investigation With a Kinetic Perspective
- ClinicalTrials.gov ID
- NCT04578431
- Acronym / sponsor ID
- AS0063221
- Conditions
- Breastfeeding, Diabetes Mellitus, Overweight
- Keywords
- Artificial sweeteners, Non-nutritive sweeteners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 8 Oct 2020 (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.
This study will investigate how some artificial sweeteners (AS) cross from blood to breastmilk in breastfeeding women after oral intake. Moreover, it will be investigated whether the kinetics of AS differ based on the women's body composition (BMI) and metabolic status (diabetes). This will be investigated through a clinical trial in which 60 women divided into three groups (normal weight, overweight and diabetic) will drink a beverage containing four AS. over a period of six hours the women will donate blood and breast milk samples in order to investigate the presence of AS.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 60 women will be divided into three groups (n=20 each) based on pre-pregnancy BMI and metabolic status. The groups are 1. Normal weight (BMI < 25), 2. Over weight (BMI > 27), 3. Diabetic
| Arm | Type | Receives |
|---|---|---|
| Intervention groups | Experimental | Dietary Supplement: Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)The participants will be given a beverage containing four artificial sweeteners (intervention) at baseline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Above 18 years old
- Able to give consent
- Able to produce enough amounts of breastmilk
- Danish/English speakers
- Pre-pregnancy BMI below 25 (20 subjects)
Key exclusion criteria (5 listed)
- Under the age of 18 years old
- Unable to give consent
- Unable to produce enough amounts of breastmilk
- Non-Danish/English speakers
- If they have consumed artificial sweeteners 24 hours prior to trial
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 |
|---|---|---|
| Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)The intervention is found in light products ingested by millions of people on a daily basis worldwide | Dietary supplement | Intervention groups |
Primary outcome
Breastmilk from mother
Time frame: Baseline, after 30 mins and afterwards once and hour for six hours
Concentration of artificial sweeteners in mother's breast milk
Blood from mother
Time frame: Baseline, after 30 mins and afterwards once and hour for six hours
Concentration of artificial sweeteners in mother's blood
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 2 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate) in people with Breastfeeding and Diabetes Mellitus, 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 7 inclusion and 5 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 2 Nov 2022. 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?
Breastmilk from mother (time frame: Baseline, after 30 mins and afterwards once and hour for six hours). The study lists 2 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 2 Nov 2022.