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Efeito da ingestão diária de eritritol versus sacarose durante 5 semanas na tolerância à glicose em adolescentes (EryAdo)

25 de setembro de 2026 atualizado por: University Hospital, Basel, Switzerland

Efeito da ingestão diária de eritritol versus sacarose durante 5 semanas na tolerância à glicose em adolescentes: um estudo piloto

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

14 anos a 55 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.))

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: EryAdo: Sucrose

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

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

Participants receive 36g erythritol per day during 5 weeks
Suplemento dietético: 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

Outros nomes:
  • E968-Eritritol
Comparador Ativo: EryClot Glucose

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

Glucose 75g dissolved in 300mL water administered once per visit
Comparador Ativo: EryClot Fructose

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

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

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

Outros nomes:
  • E968-Eritritol
Experimental: EryClot Xylitol

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

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

Outros nomes:
  • E967-xilitol
Comparador de Placebo: EryClot Water

Participants receive 300mL water once during the visit
Suplemento dietético: Water

300mL water administered once per visit

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
EryAdo: Insulin resistance
Prazo: 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
Prazo: 0 and 60 minutes

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
EryAdo: Glucose tolerance: Insulin
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Basel, Switzerland

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

18 de agosto de 2021

Conclusão Primária (Estimado)

1 de novembro de 2026

Conclusão do estudo (Estimado)

1 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de julho de 2021

Primeira postagem (Real)

19 de julho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

25 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • EryAdo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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