Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2 (ILIAS-2)
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft drinks may play a role in the development of diabetes.
Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and even modulate incretin release.
Data on human subjects are sparse and controversial, especially in a long-term manner. We therefore conduct a cross-over study to assess metabolic response to sweetened vs. non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment will be based on oral glucose tolerance tests.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Brandenburg
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Bergholz-Rehbrücke, Brandenburg, Alemania, 14458
- German Institut for Human Nutrition; Department for Clinical Nutrition
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- healthy
Exclusion Criteria:
- no metabolic disorders such as diabetes, hypothyroidism, corticoid therapy, heart or lung disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Non-sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day; soft drink does not contain glucose or any kind of sweet tasting substance
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Comparador activo: Sweetened soft drink
4-week-intervention with one liter of custom-made soft drink per day, soft drinks contains an amount of sweetener, which is isosweet compared to 100 g of sucrose in one liter of beverage
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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change in release of GIP
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GIP between the two interventions
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4 weeks (cross-over)
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change in release of GLP-1
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GLP-1 between the two interventions
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4 weeks (cross-over)
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change in release of GLP-2
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose release of GLP-2 between the two interventions
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4 weeks (cross-over)
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change in release of PYY
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose release of PYY between the two interventions
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4 weeks (cross-over)
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change in release of insulin
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose release of insulin between the two interventions
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4 weeks (cross-over)
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin secretion
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose insulin secretion between the two interventions
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4 weeks (cross-over)
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change in combined levels of glucose and insulin, expressed in calculated indices for insulin sensitivity
Periodo de tiempo: 4 weeks (cross-over)
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change in fasting state and post-glucose insulin sensitivity between the two interventions
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4 weeks (cross-over)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ILIAS-2
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