- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03354130
Biomarkers of Processed Meat Intake
Intervention Study to Identify Biomarkers of Processed Meat Intake
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Lyon, France
- International Agency for Research on Cancer
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- BMI 18-30
- Healthy
Exclusion Criteria:
- Vegetarians
- Smokers
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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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Expérimental: 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
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Plasma biomarkers of meat intake
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Biomarkers of meat intake in spot urine
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Augustin Scalbert, PhD, International Agency for Research on Cancer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- PP201711-15
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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