- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03354130
Biomarkers of Processed Meat Intake
Intervention Study to Identify Biomarkers of Processed Meat Intake
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The intake of processed meat has been linked to several adverse health outcomes such as cancer. However, little is known about the respective effects of the single products in this diverse group.
Most epidemiological studies rely on self-reported questionnaires to assess the intake of different foods. Even though this method is relatively easy to perform, it is prone to errors such as memory biases of subjects or difficulties in estimating portion size. The use of food specific biomarkers may overcome this limitation by offering an objective quantification of dietary exposure. No biomarkers for the consumption of processed meat products have been established yet.
Twelve human healthy adults will participate in a randomized cross-over dietary intervention study and will consume three different processed meat products, fresh meat or no meat, each during 3 successive days followed by a 10-day washout period. The metabolite profile in urine and plasma samples will be analysed to find metabolites that are specific for the intake of the processed meat products.
The identification of these biomarkers in blood and urine will allow a more precise estimation of intake of different processed meat products. This will enable a more robust estimation of the risk linked to the intake of processed meat products.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lyon, Francia
- International Agency for Research on Cancer
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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:
- BMI 18-30
- Healthy
Exclusion Criteria:
- Vegetarians
- Smokers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Tofu control
Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total
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Randomized cross-over dietary intervention with 5 different diets
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Experimental: Non-processed pork diet
Volunteers will consume a diet containing non-processed pork during 3 days for 5 meals in total
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Randomized cross-over dietary intervention with 5 different diets
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Experimental: Bacon diet
Volunteers will consume a diet containing bacon during 3 days for 5 meals in total
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Randomized cross-over dietary intervention with 5 different diets
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Experimental: Sausage diet
Volunteers will consume a diet containing sausage during 3 days for 5 meals in total
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Randomized cross-over dietary intervention with 5 different diets
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Experimental: Dry-cured sausage diet
Volunteers will consume a diet containing dry-cured sausage during 3 days for 5 meals in total
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Randomized cross-over dietary intervention with 5 different diets
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Plasma biomarkers of meat intake
Periodo de tiempo: After approx. 60 h of dietary intervention
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Plasma samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
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After approx. 60 h of dietary intervention
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Urinary biomarkers of meat intake
Periodo de tiempo: After approx. 48 h of dietary intervention
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Urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
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After approx. 48 h of dietary intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Biomarkers of meat intake in spot urine
Periodo de tiempo: 2 hours after the first dinner of each intervention period
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Spot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
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2 hours after the first dinner of each intervention period
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Biomarkers of meat intake in spot urine
Periodo de tiempo: Approx. 12 h after the first dinner of each intervention period
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Spot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
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Approx. 12 h after the first dinner of each intervention period
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Augustin Scalbert, PhD, International Agency for Research on Cancer
Publicaciones y enlaces útiles
Publicaciones Generales
- Li C, Imamura F, Wedekind R, Stewart ID, Pietzner M, Wheeler E, Forouhi NG, Langenberg C, Scalbert A, Wareham NJ. Development and validation of a metabolite score for red meat intake: an observational cohort study and randomized controlled dietary intervention. Am J Clin Nutr. 2022 Aug 4;116(2):511-522. doi: 10.1093/ajcn/nqac094.
- Wedekind R, Kiss A, Keski-Rahkonen P, Viallon V, Rothwell JA, Cross AJ, Rostgaard-Hansen AL, Sandanger TM, Jakszyn P, Schmidt JA, Pala V, Vermeulen R, Schulze MB, Kuhn T, Johnson T, Trichopoulou A, Peppa E, La Vechia C, Masala G, Tumino R, Sacerdote C, Wittenbecher C, de Magistris MS, Dahm CC, Severi G, Mancini FR, Weiderpass E, Gunter MJ, Huybrechts I, Scalbert A. A metabolomic study of red and processed meat intake and acylcarnitine concentrations in human urine and blood. Am J Clin Nutr. 2020 Aug 1;112(2):381-388. doi: 10.1093/ajcn/nqaa140.
- Wedekind R, Keski-Rahkonen P, Robinot N, Viallon V, Ferrari P, Engel E, Boutron-Ruault MC, Mahamat-Saleh Y, Mancini FR, Kuhn T, Johnson T, Boeing H, Bergmann M, Karakatsani A, Trichopoulou A, Peppa H, Agnoli C, Santucci de Magistris M, Palli D, Sacerdote C, Tumino R, Gunter MJ, Huybrechts I, Scalbert A. Syringol metabolites as new biomarkers for smoked meat intake. Am J Clin Nutr. 2019 Dec 1;110(6):1424-1433. doi: 10.1093/ajcn/nqz222.
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 (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
Otros números de identificación del estudio
- PP201711-15
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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