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Effetto dell'assunzione giornaliera di eritritolo rispetto al saccarosio per 5 settimane sulla tolleranza al glucosio negli adolescenti (EryAdo)

25 settembre 2026 aggiornato da: University Hospital, Basel, Switzerland

Effetto dell'assunzione giornaliera di eritritolo rispetto al saccarosio per 5 settimane sulla tolleranza al glucosio negli adolescenti: una prova pilota

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. 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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Svizzera
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Svizzera, 4002
        • St. Claraspital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 55 anni (Bambino, Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Part A EryAdo Trial:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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:

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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.))

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: EryAdo: Sucrose

Participants receive 25g sucrose per day during 5 weeks
Integratore alimentare: Sucrose

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

Participants receive 36g erythritol per day during 5 weeks
Integratore alimentare: 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

Altri nomi:
  • E968-eritritolo
Comparatore attivo: EryClot Glucose

Participants receive 75g glucose dissolved in 300mL water once during the visit (only in the pilot study)
Integratore alimentare: Glucose

Glucose 75g dissolved in 300mL water administered once per visit
Comparatore attivo: EryClot Fructose

Participants receive 25g fructose dissolved in 300mL water once during the visit (only in the pilot study)
Integratore alimentare: Fructose

Fructose 25g dissolved in 300mL water administered once per visit
Sperimentale: EryClot Erythritol

Participants receive 50g erythritol dissolved in 300mL water once during the visit
Integratore alimentare: 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

Altri nomi:
  • E968-eritritolo
Sperimentale: EryClot Xylitol

Participants receive 33.5g xylitol dissolved in 300mL water once during the visit
Integratore alimentare: Xylitol

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

Altri nomi:
  • E967-xilitolo
Comparatore placebo: EryClot Water

Participants receive 300mL water once during the visit
Integratore alimentare: Water

300mL water administered once per visit

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EryAdo: Insulin resistance
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Insulin resistance as measured by the HOMA Index.
Change from baseline to 5 weeks after polyol/sucrose intake
EryClot: Platelet Aggregation After Sweetener Ingestion
Lasso di tempo: 0 and 60 minutes

Measuring ex vivo platelet aggregation turbidimetrically using an optical aggregometer
0 and 60 minutes

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
EryAdo: Glucose tolerance: Insulin
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Insulin levels during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: Glucose
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Glucose levels during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: C-Peptide
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

C-peptide levels during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: Glucagon
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Glucagon levels during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: Fructosamin
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Fructosamin levels
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: HbA1C
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

HbA1C levels
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: Continuous glucose monitoring average
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Continuous glucose monitoring for average glucose levels
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: Continuous glucose monitoring glucose variability
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Continuous glucose monitoring for glucose variability
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose tolerance: Continuous glucose monitoring time within range
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Continuous glucose monitoring for time within range
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Glucose absorption
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Glucose absorption measured by 3-OMG concetrations during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Metabolomics
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Metabolomics in plasma, urine and stool samples, measured by 1H-NMR and Liquid Chromatography-Mass Spectrometry (LC-MS).
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Gut microbiota composition
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

The taxonomic and functional profiles of the gut microbiota (stool samples) assessed by metagenomic shotgun sequencing.
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Gastrointestinal hormones secretion: GLP-1
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Secretion of GLP-1 during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Gastrointestinal hormones secretion: PYY
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Secretion of PYY during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Gastrointestinal hormones secretion: Ghrelin
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Secretion of Ghrelin during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Gastrointestinal hormones secretion: CCK
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Secretion of CCK during OGTT
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Food intake
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Food intake assessed with self-reported food records
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Gastrointestinal tolerance
Lasso di tempo: Change from baseline to 3 and 5 weeks after polyol/sucrose intake

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
Change from baseline to 3 and 5 weeks after polyol/sucrose intake
EryAdo: Body composition: fat mass
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Body composition assessed by mean of bioimpedance analysis: fat mass in kg
Change from baseline to 5 weeks after polyol/sucrose intake
EryAdo: Body composition: fat free mass
Lasso di tempo: Change from baseline to 5 weeks after polyol/sucrose intake

Body composition assessed by mean of bioimpedance analysis: fat free mass in kg
Change from baseline to 5 weeks after polyol/sucrose intake
EryClot blood p-selectin concentrations
Lasso di tempo: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Blood p-Selectin concentrations after consumption of test solution
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood sVCAM1 concentrations
Lasso di tempo: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Blood sVCAM1 concentrations after consumption of test solution
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood PF4 concentrations
Lasso di tempo: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Blood PF4 concentrations after consumption of test solution
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood D-Dimer concentrations
Lasso di tempo: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Blood D-Dimer concentrations after consumption of test solution
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood Erythritol concentrations
Lasso di tempo: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Blood erythritol concentrations after consumption of test solution
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours
EryClot blood Xylitol concentrations
Lasso di tempo: Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Blood xylitol concentrations after consumption of test solution
Blood samples at timepoint t= -60, -1, 30, 60, 120, 180 minutes and 24, 48 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Basel, Switzerland

Investigatori

  • Investigatore principale: Bettina K. Wölnerhanssen, PD. MD, St. Clara Research Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

18 agosto 2021

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

25 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

6 luglio 2021

Primo Inserito (Effettivo)

19 luglio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EryAdo

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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