Biomarkers of Processed Meat Intake
19. november 2018 opdateret af: International Agency for Research on Cancer
Intervention Study to Identify Biomarkers of Processed Meat Intake
The intake of processed meat products has been linked to several adverse health outcomes.
However, estimation of their intake proves difficult.
This study aims at identifying biomarkers of intake for processed meat products in blood and urine.
For this, participants of a randomized cross-over dietary intervention will consume highly controlled diets containing non-processed pork, different processed meat products or no meat.
Urine and plasma will be collected and analysed to identify sets of metabolites that are specific for the intake of the processed meat products.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Lyon, Frankrig
- International Agency for Research on Cancer
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- BMI 18-30
- Healthy
Exclusion Criteria:
- Vegetarians
- Smokers
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Plasma biomarkers of meat intake
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Biomarkers of meat intake in spot urine
Tidsramme: 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
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Augustin Scalbert, PhD, International Agency for Research on Cancer
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
21. november 2017
Primær færdiggørelse (Faktiske)
30. marts 2018
Studieafslutning (Faktiske)
30. august 2018
Datoer for studieregistrering
Først indsendt
15. november 2017
Først indsendt, der opfyldte QC-kriterier
23. november 2017
Først opslået (Faktiske)
27. november 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- PP201711-15
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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