Healthy VolunteersSUVISANCT07901491
SUVY VerSus SAccharose (SUVISA)
A study testing SÜVY and Sucrose in people with Healthy Volunteers and Erythritol, run by Minerais SAS at 1 site in France.
Trial summary
Sugar substitutes are increasingly used to reduce sugar intake. SÜVY is a food ingredient combining erythritol and polydextrose. This study compares the blood sugar response, insulin response, and platelet activity after drinking a solution of SÜVY (50 g) versus a solution of regular sugar (sucrose, 50 g) in 14… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Erythritol
- What is being tested?
- SÜVY and Sucrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult volunteers aged 18 to 50 years
- Body Mass Index (BMI) between 18.5 and 29.5 kg/m²
- Fasting blood glucose < 1.10 g/L
- HbA1c < 6.0%
- Non-smoker
- No known hemostatic disorder or thrombotic history
- No antiplatelet, anticoagulant or NSAID medication within 10 days prior to each visit
- Able to provide written informed consent
Who cannot join
- Diabetes mellitus (type 1 or type 2) or any antidiabetic treatment
- Known intolerance to polyols or irritable bowel syndrome
- Pregnancy or breastfeeding
- Chronic inflammatory disease
- Participation in another clinical study within 3 months prior to inclusion
- Any condition that, in the investigator's judgment, would compromise the participant's safety or the integrity of the study data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre d'Investigation Clinique - CHU de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine, 35033
Fabrice Lainé, MD, 33299289563, fabrice.laine@chu-rennes.fr
Fabrice Bonnet, MD, PhD, fabrice.bonnet@chu-rennes.fr
About this study
Official title: Glycemic, Insulinemic and Platelet Reactivity Response After Oral Ingestion of SÜVY Versus Sucrose in Healthy Non-Diabetic Volunteers
Sugar substitutes are increasingly used to reduce sugar intake. SÜVY is a food ingredient combining erythritol and polydextrose. This study compares the blood sugar response, insulin response, and platelet activity after drinking a solution of SÜVY (50 g) versus a solution of regular sugar (sucrose, 50 g) in 14 healthy adults. Each participant takes part in two visits separated by at least 7 days, receiving one product per visit in random order. The goal is to evaluate whether SÜVY produces a lower blood sugar response than sucrose, and whether it has any effect on blood clotting markers.
Read the detailed description
SUVISA (SÜVY VerSus SAccharose) is a monocentric, randomized, controlled, two-period crossover, single-blind study conducted at the Clinical Investigation Center (CIC) of CHU Rennes - Hôpital Pontchaillou, France.
SÜVY is a food formulation combining erythritol (E968, a polyol produced by fermentation) and polydextrose (E1200, a soluble dietary fiber). Unlike intense sweeteners (aspartame, sucralose, stevia), erythritol has been shown to stimulate the release of gastrointestinal satiety hormones (GLP-1, PYY, CCK). Polydextrose undergoes colonic fermentation producing short-chain fatty acids (SCFAs). Both ingredients have established EU authorization with no specified ADI (EFSA 2023).
Recent publications have raised questions about the cardiovascular safety of erythritol (Witkowski et al., Nature Medicine, 2023). However, subsequent studies have not confirmed these findings (Wölnerhanssen et al., medRxiv, 2026). SUVISA is designed to evaluate the glycemic, insulinemic and hemostatic profile of SÜVY specifically, as a combined formulation, under realistic conditions of use.
Each participant undergoes two test visits: one with SÜVY (50 g dissolved in 250 mL water) and one with sucrose (50 g dissolved in 250 mL water), in randomized order. Blood samples are collected at baseline (T0) and at T+15, T+30, T+45, T+60, T+90 and T+120 minutes for glucose, insulin, erythritol pharmacokinetics (LC-MS/MS), platelet aggregometry (LTA), thrombin generation assay (TGA/ETP), coagulation markers (D-dimers, fibrin monomers, PT, aPTT, vWF:Ag) and a 20-analyte Luminex panel (inflammatory, endothelial and platelet markers). Digestive tolerance is assessed by visual analogue scale.
A standardized dinner is provided the evening before each test visit to neutralize the second-meal effect. A washout period of at least 7 days separates the two visits.
The randomization list is generated by the Biostatistics Department of the CIC, independently of the investigator
- Conditions
- Healthy Volunteers, Erythritol
- Being tested
- SÜVY, Sucrose
- Keywords
- Erythritol, Polydextrose, Sugar substitute, Glycemic response, Platelet reactivity, Crossover, Postprandial glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SÜVYOther
Single oral dose of 50 g SÜVY, a proprietary ingredient consisting of a single fixed formulation of erythritol (E968) and polydextrose (E1200), administered as one product, dissolved in 250 mL still water.
SucroseOther
Single oral dose of 50 g sucrose dissolved in 250 mL still water.
| Study group | Role | What they receive |
|---|---|---|
| SÜVY then Sucrose | Experimental | Participants receive a single oral dose of 50 g SÜVY dissolved in 250 mL still water at Visit 1, then a single oral dose of 50 g sucrose dissolved in 250 mL still water at Visit 2, after a washout of ≥ 7 days. Receives: Other: SÜVY; Other: Sucrose |
| Sucrose then SÜVY | Experimental | Participants receive a single oral dose of 50 g sucrose dissolved in 250 mL still water at Visit 1, then a single oral dose of 50 g SÜVY dissolved in 250 mL still water at Visit 2, after a washout of ≥ 7 days. Receives: Other: SÜVY; Other: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Area Under the Curve (iAUC) for Blood Glucose and Insulin
Incremental area under the curve (iAUC) for blood glucose and insulin concentrations measured from T0 to T+120 minutes after oral ingestion of SÜVY or sucrose, calculated by the trapezoidal method. Blood samples collected at T0, T+15, T+30, T+45, T+60, T+90 and T+120 minutes.
Measured: 0 to 120 minutes after oral ingestion
Secondary outcomes (9)
Peak Plasma Concentration (Cmax) of Erythritol
Maximum observed plasma concentration of erythritol measured by LC-MS/MS after oral ingestion of SÜVY.
Measured: 0 to 120 minutes after oral ingestion
Time to Peak Plasma Concentration (Tmax) of Erythritol
Time to reach maximum plasma concentration of erythritol measured by LC-MS/MS after oral ingestion of SÜVY.
Measured: 0 to 120 minutes after oral ingestion
Area Under the Plasma Concentration-Time Curve (AUC) of Erythritol
Area under the plasma concentration-time curve of erythritol from time 0 to 120 minutes, calculated by the trapezoidal method, measured by LC-MS/MS.
Measured: 0 to 120 minutes after oral ingestion
Urinary Excretion of Erythritol
Total urinary excretion of erythritol measured by LC-MS/MS in urine collected after oral ingestion of SÜVY.
Measured: 0 to 240 minutes after oral ingestion
Platelet Aggregation (Light Transmission Aggregometry)
Platelet aggregation measured by light transmission aggregometry (LTA) using ADP, TRAP-6, collagen and arachidonic acid as agonists.
Measured: At baseline (T0) and T+60 minutes
Thrombin Generation Assay (TGA/ETP)
Endogenous thrombin potential (ETP), peak thrombin and lag time measured by calibrated automated thrombography (CAT).
Measured: At baseline (T0) and T+60 minutes
Coagulation and Endothelial Markers
D-dimers, fibrin monomers, prothrombin time (PT), activated partial thromboplastin time (aPTT), von Willebrand factor antigen (vWF:Ag) and fibrinogen.
Measured: At baseline (T0) and T+60 minutes
Inflammatory and Endothelial Biomarkers (Luminex Panel)
20-analyte Luminex multiplex panel including inflammatory cytokines (TNF-alpha, IL-1beta, IL-6, IL-8, IL-10, MCP-1), endothelial markers (Ang-1, Ang-2, E-selectin, syndecan-1, thrombomodulin, VEGF) and platelet markers (soluble P-selectin, CXCL4/PF4).
Measured: At baseline (T0) and T+60 minutes
Digestive Tolerance
Digestive tolerance assessed by visual analogue scale (VAS, 0-10) for bloating, flatulence, abdominal pain and nausea.
Measured: At T+60, T+120 and T+240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start9 Nov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minerais SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CAMILLE E ROBERT, Study director, Minerais SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901491
- Sponsor's protocol ID
- MINERAIS-2026-SUVISA-001
- Other IDs
- 2026-A01709-42
- Acronym
- SUVISA
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flad E, Teysseire F, Budzinska A, Rehfeld JF, Beckers T, Beglinger C, Van Oudenhove L, Weltens N, Wolnerhanssen BK, Meyer-Gerspach AC. Erythritol, sucrose, and sucralose elicit similar reward responses after flavor preference learning in healthy humans. Physiol Behav. 2026 Oct 1;314:115394. doi: 10.1016/j.physbeh.2026.115394. Epub 2026 May 25.
PubMed 42184911Heianza Y, Rood JC, Champagne CM, Hu FB, Bray GA, Sacks FM, Qi L. Declines in Plasma Erythritol and Improvements in Cardiovascular Risk and Atherogenic Lipid Profiles: A 2-Year Randomized Weight-Loss Dietary Intervention Trial. Am J Clin Nutr. 2026 Sep 18:101528. doi: 10.1016/j.ajcnut.2026.101528. Online ahead of print.
PubMed 42759771Ponnusamy SS, Ganesan V, Vijayaraman P. Loss of Capture During Long Term Follow-Up After Left-Bundle-Branch-Pacing. JACC Clin Electrophysiol. 2023 Mar;9(3):418-420. doi: 10.1016/j.jacep.2022.10.006. Epub 2022 Nov 30. No abstract available.
PubMed 36752483
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic, Insulinemic and Platelet Reactivity Response After Oral Ingestion of SÜVY Versus Sucrose in Healthy Non-Diabetic Volunteers
- ClinicalTrials.gov ID
- NCT07901491
- Acronym / sponsor ID
- SUVISA / MINERAIS-2026-SUVISA-001
- Conditions
- Healthy Volunteers, Erythritol
- Keywords
- Erythritol, Polydextrose, Sugar substitute, Glycemic response, Platelet reactivity, Crossover, Postprandial glucose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Minerais SASIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Oct 2026 (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.
Sugar substitutes are increasingly used to reduce sugar intake. SÜVY is a food ingredient combining erythritol and polydextrose. This study compares the blood sugar response, insulin response, and platelet activity after drinking a solution of SÜVY (50 g) versus a solution of regular sugar (sucrose, 50 g) in 14 healthy adults. Each participant takes part in two visits separated by at least 7 days, receiving one product per visit in random order. The goal is to evaluate whether SÜVY produces a lower blood sugar response than sucrose, and whether it has any effect on blood clotting markers.
Detailed description
SUVISA (SÜVY VerSus SAccharose) is a monocentric, randomized, controlled, two-period crossover, single-blind study conducted at the Clinical Investigation Center (CIC) of CHU Rennes - Hôpital Pontchaillou, France.
SÜVY is a food formulation combining erythritol (E968, a polyol produced by fermentation) and polydextrose (E1200, a soluble dietary fiber). Unlike intense sweeteners (aspartame, sucralose, stevia), erythritol has been shown to stimulate the release of gastrointestinal satiety hormones (GLP-1, PYY, CCK). Polydextrose undergoes colonic fermentation producing short-chain fatty acids (SCFAs). Both ingredients have established EU authorization with no specified ADI (EFSA 2023).
Recent publications have raised questions about the cardiovascular safety of erythritol (Witkowski et al., Nature Medicine, 2023). However, subsequent studies have not confirmed these findings (Wölnerhanssen et al., medRxiv, 2026). SUVISA is designed to evaluate the glycemic, insulinemic and hemostatic profile of SÜVY specifically, as a combined formulation, under realistic conditions of use.
Each participant undergoes two test visits: one with SÜVY (50 g dissolved in 250 mL water) and one with sucrose (50 g dissolved in 250 mL water), in randomized order. Blood samples are collected at baseline (T0) and at T+15, T+30, T+45, T+60, T+90 and T+120 minutes for glucose, insulin, erythritol pharmacokinetics (LC-MS/MS), platelet aggregometry (LTA), thrombin generation assay (TGA/ETP), coagulation markers (D-dimers, fibrin monomers, PT, aPTT, vWF:Ag) and a 20-analyte Luminex panel (inflammatory, endothelial and platelet markers). Digestive tolerance is assessed by visual analogue scale.
A standardized dinner is provided the evening before each test visit to neutralize the second-meal effect. A washout period of at least 7 days separates the two visits.
The randomization list is generated by the Biostatistics Department of the CIC, independently of the investigator
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SÜVY then Sucrose | Experimental | Other: SÜVY, Other: SucroseParticipants receive a single oral dose of 50 g SÜVY dissolved in 250 mL still water at Visit 1, then a single oral dose of 50 g sucrose dissolved in 250 mL still water at Visit 2, after a washout of ≥ 7 days. |
| Sucrose then SÜVY | Experimental | Other: SÜVY, Other: SucroseParticipants receive a single oral dose of 50 g sucrose dissolved in 250 mL still water at Visit 1, then a single oral dose of 50 g SÜVY dissolved in 250 mL still water at Visit 2, after a washout of ≥ 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult volunteers aged 18 to 50 years
- Body Mass Index (BMI) between 18.5 and 29.5 kg/m²
- Fasting blood glucose < 1.10 g/L
- HbA1c < 6.0%
- Non-smoker
Key exclusion criteria (6 listed)
- Diabetes mellitus (type 1 or type 2) or any antidiabetic treatment
- Known intolerance to polyols or irritable bowel syndrome
- Pregnancy or breastfeeding
- Chronic inflammatory disease
- Participation in another clinical study within 3 months prior to inclusion
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 |
|---|---|---|
| SÜVYSingle oral dose of 50 g SÜVY, a proprietary ingredient consisting of a single fixed formulation of erythritol (E968) and polydextrose (E1200), administered as one product, dissolved in 250 mL still water. | Other | Sucrose then SÜVY, SÜVY then Sucrose |
| SucroseSingle oral dose of 50 g sucrose dissolved in 250 mL still water. | Other | Sucrose then SÜVY, SÜVY then Sucrose |
Primary outcome
Incremental Area Under the Curve (iAUC) for Blood Glucose and Insulin
Time frame: 0 to 120 minutes after oral ingestion
Incremental area under the curve (iAUC) for blood glucose and insulin concentrations measured from T0 to T+120 minutes after oral ingestion of SÜVY or sucrose, calculated by the trapezoidal method. Blood samples collected at T0, T+15, T+30, T+45, T+60, T+90 and T+120 minutes.
9 secondary outcomes
Peak Plasma Concentration (Cmax) of Erythritol
Time frame: 0 to 120 minutes after oral ingestion
Time to Peak Plasma Concentration (Tmax) of Erythritol
Time frame: 0 to 120 minutes after oral ingestion
Area Under the Plasma Concentration-Time Curve (AUC) of Erythritol
Time frame: 0 to 120 minutes after oral ingestion
Urinary Excretion of Erythritol
Time frame: 0 to 240 minutes after oral ingestion
Platelet Aggregation (Light Transmission Aggregometry)
Time frame: At baseline (T0) and T+60 minutes
Thrombin Generation Assay (TGA/ETP)
Time frame: At baseline (T0) and T+60 minutes
Coagulation and Endothelial Markers
Time frame: At baseline (T0) and T+60 minutes
Inflammatory and Endothelial Biomarkers (Luminex Panel)
Time frame: At baseline (T0) and T+60 minutes
Digestive Tolerance
Time frame: At T+60, T+120 and T+240 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 42184911Flad E, Teysseire F, Budzinska A, Rehfeld JF, Beckers T, Beglinger C, Van Oudenhove L, Weltens N, Wolnerhanssen BK, Meyer-Gerspach AC. Erythritol, sucrose, and sucralose elicit similar reward responses after flavor preference learning in healthy humans. Physiol Behav. 2026 Oct 1;314:115394. doi: 10.1016/j.physbeh.2026.115394. Epub 2026 May 25.
- Background: PubMed 42759771Heianza Y, Rood JC, Champagne CM, Hu FB, Bray GA, Sacks FM, Qi L. Declines in Plasma Erythritol and Improvements in Cardiovascular Risk and Atherogenic Lipid Profiles: A 2-Year Randomized Weight-Loss Dietary Intervention Trial. Am J Clin Nutr. 2026 Sep 18:101528. doi: 10.1016/j.ajcnut.2026.101528. Online ahead of print.
- Background: PubMed 36752483Ponnusamy SS, Ganesan V, Vijayaraman P. Loss of Capture During Long Term Follow-Up After Left-Bundle-Branch-Pacing. JACC Clin Electrophysiol. 2023 Mar;9(3):418-420. doi: 10.1016/j.jacep.2022.10.006. Epub 2022 Nov 30. No abstract available.
- 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.
Centre d'Investigation Clinique - CHU de Rennes - Hôpital Pontchaillou
Rennes, France
CAMILLE E ROBERT study director
Minerais SAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SÜVY and Sucrose in people with Healthy Volunteers and Erythritol, run by Minerais SAS at 1 site in France.
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 8 inclusion and 6 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: opening soon, as of the sponsor's last update on 28 Oct 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Area Under the Curve (iAUC) for Blood Glucose and Insulin (time frame: 0 to 120 minutes after oral ingestion). 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 NCT07901491, which also lists 3 linked publications.
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 28 Oct 2026.