Biomarkers of Processed Meat Intake

NCT ID: NCT03354130

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2018-08-30

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.

Conditions

Biomarkers of Processed Meat Intake in Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Tofu control

Volunteers will consume a vegetarian diet containing tofu during 3 days for 5 meals in total

Group Type: ACTIVE_COMPARATOR

Processed meat dietary intervention

Intervention Type: OTHER

Randomized cross-over dietary intervention with 5 different diets

Non-processed pork diet

Volunteers will consume a diet containing non-processed pork during 3 days for 5 meals in total

Group Type: EXPERIMENTAL

Processed meat dietary intervention

Intervention Type: OTHER

Randomized cross-over dietary intervention with 5 different diets

Bacon diet

Volunteers will consume a diet containing bacon during 3 days for 5 meals in total

Group Type: EXPERIMENTAL

Processed meat dietary intervention

Intervention Type: OTHER

Randomized cross-over dietary intervention with 5 different diets

Sausage diet

Volunteers will consume a diet containing sausage during 3 days for 5 meals in total

Group Type: EXPERIMENTAL

Processed meat dietary intervention

Intervention Type: OTHER

Randomized cross-over dietary intervention with 5 different diets

Dry-cured sausage diet

Volunteers will consume a diet containing dry-cured sausage during 3 days for 5 meals in total

Group Type: EXPERIMENTAL

Processed meat dietary intervention

Intervention Type: OTHER

Randomized cross-over dietary intervention with 5 different diets

Interventions

Processed meat dietary intervention

Randomized cross-over dietary intervention with 5 different diets

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• BMI 18-30
• Healthy

Exclusion Criteria

• Vegetarians
• Smokers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Agency for Research on Cancer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Augustin Scalbert, PhD

Role: PRINCIPAL_INVESTIGATOR

International Agency for Research on Cancer

Locations

International Agency for Research on Cancer

Lyon, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 35754192 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32492168 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31559413 (View on PubMed)

Other Identifiers

PP201711-15

Identifier Type: -

Identifier Source: org_study_id