Biomarkers of Processed Meat Intake

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.

Study Overview

• Status: Completed
• Conditions: Biomarkers of Processed Meat Intake in Healthy Subjects
• Intervention / Treatment: Other: Processed meat dietary intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • International Agency for Research on Cancer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI 18-30
• Healthy

Exclusion Criteria:

• Vegetarians
• Smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tofu control; Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total	Other: Processed meat dietary intervention; 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	Other: Processed meat dietary intervention; 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	Other: Processed meat dietary intervention; 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	Other: Processed meat dietary intervention; 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	Other: Processed meat dietary intervention; Randomized cross-over dietary intervention with 5 different diets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma biomarkers of meat intake	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	Urine samples will be analysed by UPLC-MS to identify metabolites specific for processed meat intake	After approx. 48 h of dietary intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers of meat intake in spot urine	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	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

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Investigators: Principal Investigator: Augustin Scalbert, PhD, International Agency for Research on Cancer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 23, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PP201711-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No