Efecto de la ingesta diaria de eritritol versus sacarosa durante 5 semanas sobre la tolerancia a la glucosa en adolescentes (EryAdo)
Efecto de la ingesta diaria de eritritol versus sacarosa durante 5 semanas sobre la tolerancia a la glucosa en adolescentes: una prueba 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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Canton of Basel-City
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Basel, Canton of Basel-City, Suiza, 4002
- St. Claraspital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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 |
|
Experimental: 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
Otros nombres:
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Comparador activo: 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 |
|
Comparador activo: 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 |
|
Experimental: 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
Otros nombres:
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Experimental: 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
Otros nombres:
|
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Comparador de placebos: EryClot Water
Participants receive 300mL water once during the visit |
300mL water administered once per visit |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EryAdo: Insulin resistance
Periodo de tiempo: 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
Periodo de tiempo: 0 and 60 minutes
|
Measuring ex vivo platelet aggregation turbidimetrically using an optical aggregometer |
0 and 60 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EryAdo: Glucose tolerance: Insulin
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Patrocinador
Investigadores
- Investigador principal: Bettina K. Wölnerhanssen, PD. MD, St. Clara Research Ltd.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Hiperinsulinismo
- Enfermedades Nutricionales y Metabólicas
- Resistencia a la insulina
- Químicos orgánicos
- Carbohidratos
- Químicos inorgánicos
- Alcoholes
- Polisacáridos
- Aniones
- Iones
- Electrolitos
- Hidróxidos
- Álcalies
- Óxidos
- Compuestos de oxígeno
- Disacáridos
- Oligosacáridos
- Azúcar
- Alcoholes de azúcar
- Hexisos
- Monosacáridos
- Cetosis
- Eritritol
- Agua
- Glucosa
- Xilitol
- Sacarosa
- Fructosa
Otros números de identificación del estudio
- EryAdo
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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