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Insulin ResistanceEryAdoNCT04966299

Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents

A study testing Erythritol, Sucrose and Glucose in people with Insulin Resistance and Glucose Tolerance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This trial is divided into different parts: Part A the EryAdo trial and Part B the EryClot trial. Part A EryAdo Trial: Childhood and adolescence are crucial periods for prevention of obesity, as obese children are five times more likely to be obese at adulthood than lean children. Read more about this study

Who is it for?
Ages 14 to 55 yearsHealthy volunteers can take part
What is being tested?
Erythritol, Sucrose and Glucose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSwitzerland
Study dates
18 Aug 2021to Nov 2026
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 14 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy adolescents
  • Aged 14-18 years
  • Normal weight (BMI between 15th and 85th percentile for age and gender)
  • Minimum weight of 45kg
  • Regular sugar consumption >25g/d
  • Healthy participants 18-55 years upon inclusion
  • Normal weight (BMI between 19.0-24.9 kg/m2; for in vitro: BMI < 30 kg/m2)
  • Informed consent signed by participant

Who cannot join

  • Severe acute or chronic diseases
  • Pregnancy
  • Regular intake of prebiotics
  • Regular intake of probiotics
  • Regular intake of pro-/prebiotic foods
  • Antibiotics cure within 3 months preceding the present study
Show all 20Show fewer
  • Substance abuse
  • Inability to follow procedures due to psychological disorders or insufficient knowledge of project language (German)
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.
  • Pre-existing regular consumption (>1/week) of erythritol
  • Fructose-intolerance
  • Pre-existing diet (vegetarian, vegan, gluten-free, lactose-free, caloric restriction, etc.)
  • Part B EryClot Trial:
  • Severe acute or chronic diseases
  • Pregnancy: although no contraindication, pregnancy might influence metabolic state. Female adolescents who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants a urine pregnancy test is carried out upon screening
  • Substance abuse, smoking
  • Inability to follow procedures due to psychological disorders
  • Participation in another study with investigational drug within the 30 days preceding and during the present study.
  • Pre-existing regular consumption (>1/week) of erythritol or xylitol
  • Pre-existing impairment of blood coagulation/thrombocyte function (e.g., hereditary, regular intake of anti-coagulant agents (e.g., NSAIDs, heparin, warfarin, etc.))

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • St. Claraspital

    Basel, Canton of Basel-City, 4002

Other trials in Switzerland

About this study

Official title: Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents: a Pilot Trial

This trial is divided into different parts: Part A the EryAdo trial and Part B the EryClot trial.

Part A EryAdo Trial:

Read more

Childhood and adolescence are crucial periods for prevention of obesity, as obese children are five times more likely to be obese at adulthood than lean children. To this purpose, sugar consumption should be reduced. The sugar alcohol erythritol is increasingly popular as sugar substitute in the food industry and is also recommended to diabetic patients. The substance is freely available. Recent acute studies show that erythritol has a positive influence on satiation and gastric emptying without affecting insulin and plasma glucose. In this trial, the investigators aim to assess the effect of a chronic intake of erythritol versus sucrose on insulin resistance in healthy adolescents.

Part B EryClot Trial:

In recently published studies, a prothrombotic effect of erythritol and xylitol was described.

Therefore, within a pilot study the investigators examined whether erythritol is detectable in the blood after administration of erythritol and conventional sweeteners (glucose and fructose). Also the effect on blood clotting was investigated.

These preliminary tests served to clarify the data situation so that further studies can be based on them.

The preliminary results of the pilot study indicated that there appears to be no measurable effect of erythritol on thrombocyte aggregation. This implicated that there is a discrepancy between our results and the results reported in a recent published study. This is why we need to assess the effects of erythritol in more detail (thrombocyte aggregation, and markers of platelet activation, endothelial activation and coagulation) in more subjects.

Due to a study published in 2024 describing similar prothrombotic effects for xylitol, this substance needs to be investigated as well. Thus, the participants will receive erythritol, xylitol, or water in a randomized order.

In addition to the EryClot ex vivo experiments, we will conduct in vitro experiments incubating platelet-rich plasma from healthy donors with increasing concentrations erythritol or xylitol followed by measurement of platelet aggregation by aggreegometry assay.

Read the detailed description

Part A EryAdo Trial:

This trial aims to assess the effects of the daily intake of an erythritol-sweetened beverage over 5 weeks on insulin resistance, glucose tolerance and metabolism as well as on gut microbiota. Moreover, this study will also assess the effect of the above-mentioned intervention on food intake, body composition and gastrointestinal tolerance in this population.

Part B EryClot Trial:

The aim of this study is to investigate whether erythritol is detectable in the blood after administration of glucose and fructose, whether there is an effect of erythritol or xylitol on blood clotting and to investigate the platelet responsiveness in vitro in human plasma after addition of erythritol and xylitol.

Being tested
Erythritol, Sucrose, Glucose, Fructose, Xylitol
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ErythritolDietary supplement

    Also called E968-Erythritol

    EryAdo:

    Erythritol-sweetened beverages twice a day (36g erythritol/day) with main meals during 5 weeks

    EryClot:

    Erythritol 50g dissolved in 300mL water administered once per visit

  • SucroseDietary supplement

    Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks

  • GlucoseDietary supplement

    Glucose 75g dissolved in 300mL water administered once per visit

  • FructoseDietary supplement

    Fructose 25g dissolved in 300mL water administered once per visit

  • XylitolDietary supplement

    Also called E967-Xylitol

    Xylitol 33.5g dissolved in 300mL water administered once per visit

  • WaterDietary supplement

    300mL water administered once per visit

Study groups in NCT04966299
Study groupRoleWhat they receive
EryAdo: SucroseActive comparatorParticipants receive 25g sucrose per day during 5 weeks
Receives: Dietary Supplement: Sucrose
EryAdo: ErythritolExperimentalParticipants receive 36g erythritol per day during 5 weeks
Receives: Dietary Supplement: Erythritol
EryClot GlucoseActive comparatorParticipants receive 75g glucose dissolved in 300mL water once during the visit (only in the pilot study)
Receives: Dietary Supplement: Glucose
EryClot FructoseActive comparatorParticipants receive 25g fructose dissolved in 300mL water once during the visit (only in the pilot study)
Receives: Dietary Supplement: Fructose
EryClot ErythritolExperimentalParticipants receive 50g erythritol dissolved in 300mL water once during the visit
Receives: Dietary Supplement: Erythritol
EryClot XylitolExperimentalParticipants receive 33.5g xylitol dissolved in 300mL water once during the visit
Receives: Dietary Supplement: Xylitol
EryClot WaterPlacebo comparatorParticipants receive 300mL water once during the visit
Receives: Dietary Supplement: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EryAdo: Insulin resistance

    Insulin resistance as measured by the HOMA Index.

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  2. EryClot: Platelet Aggregation After Sweetener Ingestion

    Measuring ex vivo platelet aggregation turbidimetrically using an optical aggregometer

    Measured: 0 and 60 minutes

Secondary outcomes (26)

  1. EryAdo: Glucose tolerance: Insulin

    Insulin levels during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  2. EryAdo: Glucose tolerance: Glucose

    Glucose levels during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  3. EryAdo: Glucose tolerance: C-Peptide

    C-peptide levels during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  4. EryAdo: Glucose tolerance: Glucagon

    Glucagon levels during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  5. EryAdo: Glucose tolerance: Fructosamin

    Fructosamin levels

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  6. EryAdo: Glucose tolerance: HbA1C

    HbA1C levels

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  7. EryAdo: Glucose tolerance: Continuous glucose monitoring average

    Continuous glucose monitoring for average glucose levels

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  8. EryAdo: Glucose tolerance: Continuous glucose monitoring glucose variability

    Continuous glucose monitoring for glucose variability

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  9. EryAdo: Glucose tolerance: Continuous glucose monitoring time within range

    Continuous glucose monitoring for time within range

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  10. EryAdo: Glucose absorption

    Glucose absorption measured by 3-OMG concetrations during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  11. EryAdo: Metabolomics

    Metabolomics in plasma, urine and stool samples, measured by 1H-NMR and Liquid Chromatography-Mass Spectrometry (LC-MS).

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  12. EryAdo: Gut microbiota composition

    The taxonomic and functional profiles of the gut microbiota (stool samples) assessed by metagenomic shotgun sequencing.

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  13. EryAdo: Gastrointestinal hormones secretion: GLP-1

    Secretion of GLP-1 during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  14. EryAdo: Gastrointestinal hormones secretion: PYY

    Secretion of PYY during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  15. EryAdo: Gastrointestinal hormones secretion: Ghrelin

    Secretion of Ghrelin during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  16. EryAdo: Gastrointestinal hormones secretion: CCK

    Secretion of CCK during OGTT

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  17. EryAdo: Food intake

    Food intake assessed with self-reported food records

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  18. EryAdo: Gastrointestinal tolerance

    Gastrointestinal tolerance recorded by the "Gastrointestinal Symptoms Rating Scale" (GSRS), 15 items rated on 7 Point Likert-Scale, a higher score means a worse outcome. Maximum score: 90, Minimum score: 0

    Measured: Change from baseline to 3 and 5 weeks after polyol/sucrose intake

  19. EryAdo: Body composition: fat mass

    Body composition assessed by mean of bioimpedance analysis: fat mass in kg

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  20. EryAdo: Body composition: fat free mass

    Body composition assessed by mean of bioimpedance analysis: fat free mass in kg

    Measured: Change from baseline to 5 weeks after polyol/sucrose intake

  21. EryClot blood p-selectin concentrations

    Blood p-Selectin concentrations after consumption of test solution

    Measured: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

  22. EryClot blood sVCAM1 concentrations

    Blood sVCAM1 concentrations after consumption of test solution

    Measured: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

  23. EryClot blood PF4 concentrations

    Blood PF4 concentrations after consumption of test solution

    Measured: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

  24. EryClot blood D-Dimer concentrations

    Blood D-Dimer concentrations after consumption of test solution

    Measured: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

  25. EryClot blood Erythritol concentrations

    Blood erythritol concentrations after consumption of test solution

    Measured: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

  26. EryClot blood Xylitol concentrations

    Blood xylitol concentrations after consumption of test solution

    Measured: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2021
  2. Study start18 Aug 2021
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part A EryAdo Trial: This trial is a randomized parallel, double-blind trial. The project set-up is single-center, national. There will be 2 study arms. Part B EryClot Trial: This trial is a randomized, single-blind, crossover trial. The project set-up is single-center, national. There will be 3 study arms. It encompasses also an in vitro part where human thrombocytes were exposed to different concentrations of erythritol and xylitol.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04966299
Sponsor's protocol ID
EryAdo
Acronym
EryAdo
Status last verified
Sep 2026
First submitted
25 May 2021
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Erythritol, Sucrose and Glucose in people with Insulin Resistance and Glucose Tolerance, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

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 20 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?

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?

EryAdo: Insulin resistance (time frame: Change from baseline to 5 weeks after polyol/sucrose intake). 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?

On the ClinicalTrials.gov record for NCT04966299.

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 30 Sep 2026.

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