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Влияние ежедневного потребления эритрита в сравнении с сахарозой в течение 5 недель на толерантность к глюкозе у подростков (EryAdo)

25 сентября 2026 г. обновлено: University Hospital, Basel, Switzerland

Влияние ежедневного приема эритрита по сравнению с потреблением сахарозы в течение 5 недель на толерантность к глюкозе у подростков: экспериментальное исследование

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.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

30

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 14 лет до 55 лет (Ребенок, Взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.))

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: EryAdo: Sucrose

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

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

Participants receive 36g erythritol per day during 5 weeks
Диетическая добавка: 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

Другие имена:
  • E968-Эритрит
Активный компаратор: EryClot Glucose

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

Glucose 75g dissolved in 300mL water administered once per visit
Активный компаратор: EryClot Fructose

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

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

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

Другие имена:
  • E968-Эритрит
Экспериментальный: EryClot Xylitol

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

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

Другие имена:
  • E967-ксилит
Плацебо Компаратор: EryClot Water

Participants receive 300mL water once during the visit
Диетическая добавка: Water

300mL water administered once per visit

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
EryAdo: Insulin resistance
Временное ограничение: 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
Временное ограничение: 0 and 60 minutes

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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
EryAdo: Glucose tolerance: Insulin
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University Hospital, Basel, Switzerland

Следователи

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

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

18 августа 2021 г.

Первичное завершение (Оцененный)

1 ноября 2026 г.

Завершение исследования (Оцененный)

1 ноября 2026 г.

Даты регистрации исследования

Первый отправленный

25 мая 2021 г.

Впервые представлено, что соответствует критериям контроля качества

6 июля 2021 г.

Первый опубликованный (Действительный)

19 июля 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

30 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

25 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • EryAdo

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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