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Wpływ dziennego spożycia erytrytolu w porównaniu z sacharozą w ciągu 5 tygodni na tolerancję glukozy u młodzieży (EryAdo)

25 września 2026 zaktualizowane przez: University Hospital, Basel, Switzerland

Wpływ codziennego spożycia erytrytolu w porównaniu z sacharozą w ciągu 5 tygodni na tolerancję glukozy u młodzieży: badanie pilotażowe

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

14 lat do 55 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.))

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: EryAdo: Sucrose

Participants receive 25g sucrose per day during 5 weeks

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

Eksperymentalny: EryAdo: Erythritol

Participants receive 36g erythritol per day during 5 weeks

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

Inne nazwy:
  • E968-erytrytol
Aktywny komparator: EryClot Glucose

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

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

Aktywny komparator: EryClot Fructose

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

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

Eksperymentalny: EryClot Erythritol

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

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

Inne nazwy:
  • E968-erytrytol
Eksperymentalny: EryClot Xylitol

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

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

Inne nazwy:
  • E967-ksylitol
Komparator placebo: EryClot Water

Participants receive 300mL water once during the visit

300mL water administered once per visit

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
EryAdo: Insulin resistance
Ramy czasowe: 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
Ramy czasowe: 0 and 60 minutes

Measuring ex vivo platelet aggregation turbidimetrically using an optical aggregometer

0 and 60 minutes

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
EryAdo: Glucose tolerance: Insulin
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 sierpnia 2021

Zakończenie podstawowe (Szacowany)

1 listopada 2026

Ukończenie studiów (Szacowany)

1 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

25 maja 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 lipca 2021

Pierwszy wysłany (Rzeczywisty)

19 lipca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • EryAdo

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .