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Päivittäisen erytritolin ja sakkaroosin saannin vaikutus yli 5 viikon ajan nuorten glukoositoleranssiin (EryAdo)

perjantai 25. syyskuuta 2026 päivittänyt: University Hospital, Basel, Switzerland

Päivittäisen erytritolin ja sakkaroosin saannin vaikutus yli 5 viikon ajan nuorten glukoositoleranssiin: pilottikoe

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.

Tutkimuksen yleiskatsaus

Tila

Aktiivinen, ei rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

30

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

14 vuotta - 55 vuotta (Lapsi, Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.))

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Active Comparator: EryAdo: Sucrose

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

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

Participants receive 36g erythritol per day during 5 weeks
Ravintolisä: 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

Muut nimet:
  • E968-erytritoli
Active Comparator: EryClot Glucose

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

Glucose 75g dissolved in 300mL water administered once per visit
Active Comparator: EryClot Fructose

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

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

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

Muut nimet:
  • E968-erytritoli
Kokeellinen: EryClot Xylitol

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

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

Muut nimet:
  • E967-ksylitoli
Placebo Comparator: EryClot Water

Participants receive 300mL water once during the visit
Ravintolisä: Water

300mL water administered once per visit

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
EryAdo: Insulin resistance
Aikaikkuna: 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
Aikaikkuna: 0 and 60 minutes

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
EryAdo: Glucose tolerance: Insulin
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

University Hospital, Basel, Switzerland

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Ensimmäinen Lähetetty (Todellinen)

Maanantai 19. heinäkuuta 2021

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Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 30. syyskuuta 2026

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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