- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03354130
Biomarkers of Processed Meat Intake
Intervention Study to Identify Biomarkers of Processed Meat Intake
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Lyon, Frankreich
- International Agency for Research on Cancer
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- BMI 18-30
- Healthy
Exclusion Criteria:
- Vegetarians
- Smokers
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Tofu control
Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total
|
Randomized cross-over dietary intervention with 5 different diets
|
Experimental: Non-processed pork diet
Volunteers will consume a diet containing non-processed pork during 3 days for 5 meals in total
|
Randomized cross-over dietary intervention with 5 different diets
|
Experimental: Bacon diet
Volunteers will consume a diet containing bacon during 3 days for 5 meals in total
|
Randomized cross-over dietary intervention with 5 different diets
|
Experimental: Sausage diet
Volunteers will consume a diet containing sausage during 3 days for 5 meals in total
|
Randomized cross-over dietary intervention with 5 different diets
|
Experimental: Dry-cured sausage diet
Volunteers will consume a diet containing dry-cured sausage during 3 days for 5 meals in total
|
Randomized cross-over dietary intervention with 5 different diets
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Plasma biomarkers of meat intake
Zeitfenster: After approx. 60 h of dietary intervention
|
Plasma samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
|
After approx. 60 h of dietary intervention
|
Urinary biomarkers of meat intake
Zeitfenster: After approx. 48 h of dietary intervention
|
Urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
|
After approx. 48 h of dietary intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Biomarkers of meat intake in spot urine
Zeitfenster: 2 hours after the first dinner of each intervention period
|
Spot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
|
2 hours after the first dinner of each intervention period
|
Biomarkers of meat intake in spot urine
Zeitfenster: Approx. 12 h after the first dinner of each intervention period
|
Spot urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake
|
Approx. 12 h after the first dinner of each intervention period
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Augustin Scalbert, PhD, International Agency for Research on Cancer
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- PP201711-15
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Processed meat dietary intervention
-
University of VermontAbgeschlossen