Healthy AdultsNCT06520293
Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults
A study testing Sweet Beverage in people with Healthy Adults, run by Amai Proteins at 1 site in Israel.
Trial summary
The study aims to evaluate, for the first time, the post-prandial effects of a single oral administration of Serendipity Berry Sweet Protein sweelin® compared to glucose and stevia, as a commercial sweetener, in healthy adults. The study design is a single center, randomized, crossover study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Sweet Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Sep 2024to 12 Nov 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Age 18-70 years
- BMI between 18.0 and 33.0 calculated as Weight (Kg)/Height (m2).
- Stable weight in the last 3 months (+/-5kg).
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Who cannot join
- Pregnant or breastfeeding women.
- Subjects with a significant allergic response or history of food allergies deemed clinically significant or exclusionary for the study.
- Diabetes mellitus or use of medications affecting glucose metabolism.
- Subjects with any gastrointestinal disease which may affect absorption
- Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
- Subjects which have undergone major surgery in the last 3 months.
- Subjects who are non-cooperative or unwilling to sign the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults: a Crossover, Double Blinded Clinical Trial
The study aims to evaluate, for the first time, the post-prandial effects of a single oral administration of Serendipity Berry Sweet Protein sweelin® compared to glucose and stevia, as a commercial sweetener, in healthy adults. The study design is a single center, randomized, crossover study.
Each subject will receive a single oral dose of sweelin® compared with an equivalently sweet dose of glucose and stevia dissolved in a water beverage with flavor.
The advantage of a crossover design is that it will allow to compare the blood glucose and insulin levels of each subject to his baseline in every test beverage, and to remove the inter-subject variability. The post-prandial effects will be monitored with multiple blood sampling up to 120 minutes post dosing.
- Conditions
- Healthy Adults
- Being tested
- Sweet Beverage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweet BeverageOther
A beverage containing different sweet ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Beverage containing Serendipity Berry Sweet Protein | Experimental | Single dose of 400 ml beverage containing Serendipity Berry Sweet Protein to be consumed in less than 15 minutes. The beverage will be at a similar sweet potency as 75 grams glucose. Receives: Other: Sweet Beverage |
| Beverage containing glucose | Other | Single dose of 400 ml beverage containing 75 grams glucose to be consumed in less than 15 minutes. Receives: Other: Sweet Beverage |
| Beverage containing Stevia | Other | Single dose of 400 ml beverage containing Stevia to be consumed in less than 15 minutes. The beverage will be at a similar sweet potency as 75 grams glucose. Receives: Other: Sweet Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose incremental area under the curve (iAUC)
To monitor blood glucose incremental area under the curve (iAUC) response of sweelin® in healthy adult subjects, following a single oral administration, in comparison to glucose and stevia.
Measured: 120 minutes after single oral dose administration
Secondary outcomes (1)
Insulin incremental area under the curve (iAUC)
To monitor blood insulin incremental area under the curve (iAUC) response of sweelin®, following a single oral administration, in comparison to glucose and stevia.
Measured: 120 minutes after single oral dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start9 Sep 2024
- Primary completion12 Nov 2024
- Study completion12 Nov 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 Healthy AdultsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amai Proteins
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Zeltser, Prof., Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520293
- Sponsor's protocol ID
- SWEELIN01
- Status last verified
- Nov 2026
- First submitted
- 21 Jul 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Lifshitz Y, Saban R, Paz S, Gorzalczany Paz K, Samish I, Jenkins AL, Zeltser D, Eldor R. sweelin(R), a novel sweet protein, does not affect blood glucose and insulin levels - a double-blind, crossover, randomized study. Food Chem. 2026 Aug 15;520:149790. doi: 10.1016/j.foodchem.2026.149790. Epub 2026 May 25.
PubMed 42208445
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Oral Dose of Sweet Protein Sweelin® on Blood Glucose and Insulin Levels in Healthy Adults: a Crossover, Double Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT06520293
- Acronym / sponsor ID
- SWEELIN01
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Amai ProteinsIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 25 Jul 2024 (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 study aims to evaluate, for the first time, the post-prandial effects of a single oral administration of Serendipity Berry Sweet Protein sweelin® compared to glucose and stevia, as a commercial sweetener, in healthy adults. The study design is a single center, randomized, crossover study.
Each subject will receive a single oral dose of sweelin® compared with an equivalently sweet dose of glucose and stevia dissolved in a water beverage with flavor.
The advantage of a crossover design is that it will allow to compare the blood glucose and insulin levels of each subject to his baseline in every test beverage, and to remove the inter-subject variability. The post-prandial effects will be monitored with multiple blood sampling up to 120 minutes post dosing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beverage containing Serendipity Berry Sweet Protein | Experimental | Other: Sweet BeverageSingle dose of 400 ml beverage containing Serendipity Berry Sweet Protein to be consumed in less than 15 minutes. The beverage will be at a similar sweet potency as 75 grams glucose. |
| Beverage containing glucose | Other | Other: Sweet BeverageSingle dose of 400 ml beverage containing 75 grams glucose to be consumed in less than 15 minutes. |
| Beverage containing Stevia | Other | Other: Sweet BeverageSingle dose of 400 ml beverage containing Stevia to be consumed in less than 15 minutes. The beverage will be at a similar sweet potency as 75 grams glucose. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy subjects
- Age 18-70 years
- BMI between 18.0 and 33.0 calculated as Weight (Kg)/Height (m2).
- Stable weight in the last 3 months (+/-5kg).
- Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- Subjects with a significant allergic response or history of food allergies deemed clinically significant or exclusionary for the study.
- Diabetes mellitus or use of medications affecting glucose metabolism.
- Subjects with any gastrointestinal disease which may affect absorption
- Subjects with any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
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 |
|---|---|---|
| Sweet BeverageA beverage containing different sweet ingredients. | Other | Beverage containing Serendipity Berry Sweet Protein, Beverage containing Stevia, Beverage containing glucose |
Primary outcome
Blood glucose incremental area under the curve (iAUC)
Time frame: 120 minutes after single oral dose administration
To monitor blood glucose incremental area under the curve (iAUC) response of sweelin® in healthy adult subjects, following a single oral administration, in comparison to glucose and stevia.
1 secondary outcome
Insulin incremental area under the curve (iAUC)
Time frame: 120 minutes after single oral dose administration
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 4 Nov 2026.
- Derived from this study: PubMed 42208445Lifshitz Y, Saban R, Paz S, Gorzalczany Paz K, Samish I, Jenkins AL, Zeltser D, Eldor R. sweelin(R), a novel sweet protein, does not affect blood glucose and insulin levels - a double-blind, crossover, randomized study. Food Chem. 2026 Aug 15;520:149790. doi: 10.1016/j.foodchem.2026.149790. Epub 2026 May 25.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
David Zeltser, Prof. principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweet Beverage in people with Healthy Adults, run by Amai Proteins at 1 site in Israel.
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 5 inclusion and 7 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 4 Nov 2026. 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 Israel. 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?
Blood glucose incremental area under the curve (iAUC) (time frame: 120 minutes after single oral dose administration). 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 NCT06520293, 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 4 Nov 2026.