Clinical trial NCT03354130: Biomarkers of Processed Meat Intake
Official title: Intervention Study to Identify Biomarkers of Processed Meat Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biomarkers of Processed Meat Intake in Healthy Subjects
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Volunteers consume five different diets in a randomized cross-over dietary intervention.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI 18-30
* Healthy

Exclusion Criteria:

* Vegetarians
* Smokers

Primary outcomes:
measure: Plasma biomarkers of meat intake
timeFrame: After approx. 60 h of dietary intervention
measure: Urinary biomarkers of meat intake
timeFrame: After approx. 48 h of dietary intervention
Secondary outcomes:
measure: Biomarkers of meat intake in spot urine
timeFrame: 2 hours after the first dinner of each intervention period
measure: Biomarkers of meat intake in spot urine
timeFrame: Approx. 12 h after the first dinner of each intervention period
Other outcomes:
Locations:
city: Lyon
country: France
facility: International Agency for Research on Cancer
Study officials:
affiliation: International Agency for Research on Cancer
name: Augustin Scalbert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.