Normal Physiological Response to Sweet DrinksSWEETBRAINNCT05575687
Brain and Glycemic Responses to Sweet Soft Drinks
A study testing Water (reference), Sucrose and Sucralose in people with Normal Physiological Response to Sweet Drinks, run by Wageningen University at 1 site in Netherlands.
Trial summary
The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Physiological Response to Sweet Drinks
- What is being tested?
- Water (reference), Sucrose and Sucralose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jan 2023to 15 Mar 2024
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 30 years
- BMI between 18.5 and 25 kg/m2
- Apparently healthy (self-reported)
- Right-handed (because brain responses may differ between right- and left handed individuals)
- Sufficient blood hemoglobin (Hb) levels (women > 7,5; men > 8.5 g/dl) and having antecubital veins suitable for blood sampling via a catheter
- Willing to comply with the study procedures
- Willing to be informed about incidental findings of pathology and consenting to informing their general practitioner about this.
Who cannot join
- Having disturbances of glucose metabolism such as being prediabetic or diabetic
- Use of medication that could influence study results including insulin/metformin/proton pump inhibitors, antacids, anti-depressants
- Allergy or intolerance for any of the study products/compounds (sucrose, sucralose, stevia extract, allulose, monk fruit extract)
- Being a regular smoker (smoking more than one cigarette or e-cigarette with nicotin per day)
- Drinking more than 14 glasses of alcohol a week
- Having genetic, psychiatric or neurological diseases affecting the brain
Show all 16Show fewer
- Gastric disorders or regular gastric complaints (more than once per week), for example heart burn
- Having renal or hepatic disease
- Using recreational drugs more than once per week (e.g. marihuana, XTC, GHB, laughing gas)
- Having given a blood donation in the past two months
- Being pregnant, lactating or planning on becoming pregnant during the study
- Currently following or having followed calorie-restricted diet in the past two months
- Participating in other research during the study period
- Not having a general practitioner
- Being an employee or student of the Division of Human Nutrition and Health
- Having a contra-indication to MRI scanning
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Human Research Unit - Division of Human Nutrition and Health
Wageningen, 6708 WE
About this study
Official title: Brain and Glycemic Responses to Soft Drinks With Different Sweeteners
The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years.
The main question it aims to answer is in how far brain and glycemic responses differ between a sugar-sweetened drink and drinks sweetened with different low-caloric sweeteners.
Participants will visit after an overnight fast six times and then have an MRI brain scan before and after consumption of 500 ml of one of the study drinks (beverage sweetened with sucrose or one of four non-caloric sweeteners, or water).
Read the detailed description
Rationale: The brain is crucial in the regulation of energy intake and maintaining homeostasis which is subserved by an interaction of homeostatic and reward-related brain areas. These brain areas integrate multiple neural and hormonal signals related to energy content such as sweet taste and food reward in the form of ingested energy. Sugar-sweetened soft drinks have been shown to contribute to overconsumption and obesity. Therefore, there is great consumer interest in drinks with low-caloric sweeteners because they do not contribute to energy intake while still providing the hedonic experience of sweet taste. However, different low-caloric sweeteners may have differential effects on the brain because of (subliminal) taste difference and their different metabolic fate. We hypothesize that the brain and glycemic responses to drinks sweetened with sugar and different low-caloric sweeteners will be different. This may have implications for their reward value.
Objective: To determine changes in brain activity in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners.
Study design: Randomized crossover design with six treatments. Study population: 30 healthy, non-smoking, normal-weight individuals, aged between 18 and 30 years.
Intervention: Participants will be scanned using MRI before and after consumption of six 500-ml drinks: water; water + sucrose; water + sucralose; water + stevia extract; water + allulose + stevia; water + monk fruit extract. Regional cerebral blood flow (rCBF) and resting state functional MRI (rsfMRI) scans will be made at baseline and at t=5 and t=30 min. Additionally, gastric emptying of the drinks will be examined through gastric MRI at t=15, 25 and 45 min. Blood samples will be collected to measure changes in insulin and glucose levels at baseline and at t=5, 15, 30, 45 and 60 min for all sweet treatments. Participants will rate their appetite and thirst at baseline and at t=15, 25, 30, 45 and 60 min.
- Being tested
- Water (reference), Sucrose, Sucralose, Stevia, Monk fruit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water (reference)Other
Ingestion of 500 ml mineral water
SucroseOther
Ingestion of 500 ml of a flavored mineral water sweetened with sucrose
SucraloseOther
Ingestion of 500 ml of a flavored mineral water sweetened with sucralose
SteviaOther
Ingestion of 500 ml of a flavored mineral water sweetened with stevia extract
Monk fruitOther
Ingestion of 500 ml of a flavored mineral water sweetened with monk fruit extract
Allulose + steviaOther
Ingestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract
| Study group | Role | What they receive |
|---|---|---|
| Water | Other | Ingestion of 500 ml of mineral water Receives: Other: Water (reference) |
| Sucrose | Other | Ingestion of 500 ml of a flavored mineral water sweetened with sucrose Receives: Other: Sucrose |
| Sucralose | Other | Ingestion of 500 ml of a flavored mineral water sweetened with sucralose Receives: Other: Sucralose |
| Stevia | Other | Ingestion of 500 ml of a flavored mineral water sweetened with stevia extract Receives: Other: Stevia |
| Monk fruit | Other | Ingestion of 500 ml of a flavored mineral water sweetened with monk fruit extract Receives: Other: Monk fruit |
| Allulose + stevia | Other | Ingestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract Receives: Other: Allulose + stevia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local brain perfusion
Change from baseline rCBF in homeostatic and reward-related brain areas in a priori regions of interest (hypothalamus, ventral striatum, dopaminergic midbrain) over time
Measured: T=5 and T=30 minutes after the start of consumption
Secondary outcomes (4)
Seed-based functional connectivity
Change from baseline in seed-based functional connectivity of a priori regions of interest (hypothalamus, ventral striatum, dopaminergic midbrain) over time
Measured: T=5, T=30 minutes after the start of consumption
Blood plasma glucose
Change from baseline plasma glucose over time
Measured: T=5, 15, 30, 45 and 60 minutes after the start of consumption
Blood plasma insulin
Change from baseline plasma insulin over time
Measured: T=5, 15, 30, 45 and 60 minutes after the start of consumption
Gastric content volume
Change from baseline gastric content volume over time in milliliter as determined from an abdominal MRI scan
Measured: Baseline, T=15, 25 and 45 minutes after the start of consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start9 Jan 2023
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Physiological Response to Sweet DrinksStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Tate & Lyle
- Responsible party
- Principal investigator, Paul Smeets, Wageningen University
- Investigators
- Paul Smeets, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575687
- Sponsor's protocol ID
- NL81742.091.22
- Acronym
- SWEETBRAIN
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smeets PA, Veit R, Oosterink E, Meijboom S, Risso D, Preissl H, Kullmann S. Brain and physiological responses to flavored waters with different sweeteners: a randomized crossover study in healthy young adults. Am J Clin Nutr. 2026 Aug;124(2):101401. doi: 10.1016/j.ajcnut.2026.101401. Epub 2026 Jun 20.
PubMed 42323164
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Glycemic Responses to Soft Drinks With Different Sweeteners
- ClinicalTrials.gov ID
- NCT05575687
- Acronym / sponsor ID
- SWEETBRAIN / NL81742.091.22
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Tate & Lyle
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 12 Oct 2022 (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.
The goal of this observational study is to determine changes in brain activity and blood sugar in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners in healthy normal-weight individuals aged between 18 and 30 years.
The main question it aims to answer is in how far brain and glycemic responses differ between a sugar-sweetened drink and drinks sweetened with different low-caloric sweeteners.
Participants will visit after an overnight fast six times and then have an MRI brain scan before and after consumption of 500 ml of one of the study drinks (beverage sweetened with sucrose or one of four non-caloric sweeteners, or water).
Detailed description
Rationale: The brain is crucial in the regulation of energy intake and maintaining homeostasis which is subserved by an interaction of homeostatic and reward-related brain areas. These brain areas integrate multiple neural and hormonal signals related to energy content such as sweet taste and food reward in the form of ingested energy. Sugar-sweetened soft drinks have been shown to contribute to overconsumption and obesity. Therefore, there is great consumer interest in drinks with low-caloric sweeteners because they do not contribute to energy intake while still providing the hedonic experience of sweet taste. However, different low-caloric sweeteners may have differential effects on the brain because of (subliminal) taste difference and their different metabolic fate. We hypothesize that the brain and glycemic responses to drinks sweetened with sugar and different low-caloric sweeteners will be different. This may have implications for their reward value.
Objective: To determine changes in brain activity in response to the ingestion of flavored waters sweetened with either the nutritive sugar sucrose or different low-caloric sweeteners.
Study design: Randomized crossover design with six treatments. Study population: 30 healthy, non-smoking, normal-weight individuals, aged between 18 and 30 years.
Intervention: Participants will be scanned using MRI before and after consumption of six 500-ml drinks: water; water + sucrose; water + sucralose; water + stevia extract; water + allulose + stevia; water + monk fruit extract. Regional cerebral blood flow (rCBF) and resting state functional MRI (rsfMRI) scans will be made at baseline and at t=5 and t=30 min. Additionally, gastric emptying of the drinks will be examined through gastric MRI at t=15, 25 and 45 min. Blood samples will be collected to measure changes in insulin and glucose levels at baseline and at t=5, 15, 30, 45 and 60 min for all sweet treatments. Participants will rate their appetite and thirst at baseline and at t=15, 25, 30, 45 and 60 min.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Water | Other | Other: Water (reference)Ingestion of 500 ml of mineral water |
| Sucrose | Other | Other: SucroseIngestion of 500 ml of a flavored mineral water sweetened with sucrose |
| Sucralose | Other | Other: SucraloseIngestion of 500 ml of a flavored mineral water sweetened with sucralose |
| Stevia | Other | Other: SteviaIngestion of 500 ml of a flavored mineral water sweetened with stevia extract |
| Monk fruit | Other | Other: Monk fruitIngestion of 500 ml of a flavored mineral water sweetened with monk fruit extract |
| Allulose + stevia | Other | Other: Allulose + steviaIngestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 30 years
- BMI between 18.5 and 25 kg/m2
- Apparently healthy (self-reported)
- Right-handed (because brain responses may differ between right- and left handed individuals)
- Sufficient blood hemoglobin (Hb) levels (women > 7,5; men > 8.5 g/dl) and having antecubital veins suitable for blood sampling via a catheter
Key exclusion criteria (16 listed)
- Having disturbances of glucose metabolism such as being prediabetic or diabetic
- Use of medication that could influence study results including insulin/metformin/proton pump inhibitors, antacids, anti-depressants
- Allergy or intolerance for any of the study products/compounds (sucrose, sucralose, stevia extract, allulose, monk fruit extract)
- Being a regular smoker (smoking more than one cigarette or e-cigarette with nicotin per day)
- Drinking more than 14 glasses of alcohol a week
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 |
|---|---|---|
| Water (reference)Ingestion of 500 ml mineral water | Other | Water |
| SucroseIngestion of 500 ml of a flavored mineral water sweetened with sucrose | Other | Sucrose |
| SucraloseIngestion of 500 ml of a flavored mineral water sweetened with sucralose | Other | Sucralose |
| SteviaIngestion of 500 ml of a flavored mineral water sweetened with stevia extract | Other | Stevia |
| Monk fruitIngestion of 500 ml of a flavored mineral water sweetened with monk fruit extract | Other | Monk fruit |
| Allulose + steviaIngestion of 500 ml of a flavored mineral water sweetened with allulose and stevia extract | Other | Allulose + stevia |
Primary outcome
Local brain perfusion
Time frame: T=5 and T=30 minutes after the start of consumption
Change from baseline rCBF in homeostatic and reward-related brain areas in a priori regions of interest (hypothalamus, ventral striatum, dopaminergic midbrain) over time
4 secondary outcomes
Seed-based functional connectivity
Time frame: T=5, T=30 minutes after the start of consumption
Blood plasma glucose
Time frame: T=5, 15, 30, 45 and 60 minutes after the start of consumption
Blood plasma insulin
Time frame: T=5, 15, 30, 45 and 60 minutes after the start of consumption
Gastric content volume
Time frame: Baseline, T=15, 25 and 45 minutes after the start of consumption
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 1 Apr 2024.
- Derived from this study: PubMed 42323164Smeets PA, Veit R, Oosterink E, Meijboom S, Risso D, Preissl H, Kullmann S. Brain and physiological responses to flavored waters with different sweeteners: a randomized crossover study in healthy young adults. Am J Clin Nutr. 2026 Aug;124(2):101401. doi: 10.1016/j.ajcnut.2026.101401. Epub 2026 Jun 20.
- Individual participant dataSharing planned: No
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.
Paul Smeets, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water (reference), Sucrose and Sucralose in people with Normal Physiological Response to Sweet Drinks, run by Wageningen University at 1 site in Netherlands.
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 16 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 1 Apr 2024. 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 Netherlands. 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?
Local brain perfusion (time frame: T=5 and T=30 minutes after the start of consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05575687, which also lists 1 linked publication.
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 1 Apr 2024.