Fecal microbiome as determinant of the effect of diet on colorectal cancer risk: comparison of meat-based versus pesco-vegetarian diets (the MeaTIc study).


Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
09 Dec 2019
Historique:
received: 08 08 2019
accepted: 11 10 2019
entrez: 10 12 2019
pubmed: 10 12 2019
medline: 28 7 2020
Statut: epublish

Résumé

Convincing evidence suggests that the risk of colorectal cancer (CRC) is increased by the typical Western diet characterized by high consumption of red and processed meat. In addition, some epidemiological studies suggest a reduction in the risk of CRC associated with fish consumption. The role of the gut microbiome in this diet-associated risk is not well understood. This is a randomized parallel open clinical trial comprising a total of 150 clinically healthy subjects randomly assigned to three groups: a meat-based diet of which 4 portions per week are red meat (1 portion = 150 g), 3 portions per week are processed meat (1 portion = 50 g), and 1 portion per week is poultry (1 portion = 150 g), for a total amount of 900 g per week of meat and derivatives; a meat-based diet supplemented with alpha-tocopherol; and a pesco-vegetarian diet excluding fresh and processed meat and poultry, but which includes 3 portions per week of fish for a total amount of 450 g per week. Each intervention will last 3 months. The three diets will be isocaloric and of three different sizes according to specific energy requirements. Anthropometric measurements, body composition, and blood and fecal samples will be obtained from each participant at the beginning and end of each intervention phase. The measure of the primary outcome will be the change from baseline in DNA damage induced by fecal water using the comet assay in a cellular model. Secondary outcome measures will be changes in the profile of fecal microbiomes, global fecal and urinary peroxidation markers, and neoplastic biomarkers. Although epidemiological data support the promoting role of meat and the possible protective role of fish in colon carcinogenesis, no study has directly compared dietary profiles characterized by the presence of these two food groups and the role of the gut microbiome in these diet-associated CRC risks. This study will test the effect of these dietary profiles on validated CRC risk biomarkers. ClinicalTrials.gov, NCT03416777. Registered on 3 May 2018.

Sections du résumé

BACKGROUND BACKGROUND
Convincing evidence suggests that the risk of colorectal cancer (CRC) is increased by the typical Western diet characterized by high consumption of red and processed meat. In addition, some epidemiological studies suggest a reduction in the risk of CRC associated with fish consumption. The role of the gut microbiome in this diet-associated risk is not well understood.
METHODS/DESIGN METHODS
This is a randomized parallel open clinical trial comprising a total of 150 clinically healthy subjects randomly assigned to three groups: a meat-based diet of which 4 portions per week are red meat (1 portion = 150 g), 3 portions per week are processed meat (1 portion = 50 g), and 1 portion per week is poultry (1 portion = 150 g), for a total amount of 900 g per week of meat and derivatives; a meat-based diet supplemented with alpha-tocopherol; and a pesco-vegetarian diet excluding fresh and processed meat and poultry, but which includes 3 portions per week of fish for a total amount of 450 g per week. Each intervention will last 3 months. The three diets will be isocaloric and of three different sizes according to specific energy requirements. Anthropometric measurements, body composition, and blood and fecal samples will be obtained from each participant at the beginning and end of each intervention phase. The measure of the primary outcome will be the change from baseline in DNA damage induced by fecal water using the comet assay in a cellular model. Secondary outcome measures will be changes in the profile of fecal microbiomes, global fecal and urinary peroxidation markers, and neoplastic biomarkers.
DISCUSSION CONCLUSIONS
Although epidemiological data support the promoting role of meat and the possible protective role of fish in colon carcinogenesis, no study has directly compared dietary profiles characterized by the presence of these two food groups and the role of the gut microbiome in these diet-associated CRC risks. This study will test the effect of these dietary profiles on validated CRC risk biomarkers.
TRIAL REGISTRATION BACKGROUND
ClinicalTrials.gov, NCT03416777. Registered on 3 May 2018.

Identifiants

pubmed: 31815647
doi: 10.1186/s13063-019-3801-x
pii: 10.1186/s13063-019-3801-x
pmc: PMC6902610
doi:

Banques de données

ClinicalTrials.gov
['NCT03416777']

Types de publication

Comparative Study Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

688

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Auteurs

Francesco Sofi (F)

Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. francesco.sofi@unifi.it.
Unit of Clinical Nutrition, Careggi University Hospital, Florence, Italy. francesco.sofi@unifi.it.
Don Carlo Gnocchi Foundation Italy, Onlus IRCCS, Florence, Italy. francesco.sofi@unifi.it.

Monica Dinu (M)

Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Giuditta Pagliai (G)

Department of Experimental and Clinical Medicine, School of Human Health Sciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Fabrice Pierre (F)

INRA, ToxAlim (Research Centre in Food Toxicology), Universitè de Toulouse, ENVT, INP-Purpan, UPS, Toulouse, France.

Francoise Gueraud (F)

INRA, ToxAlim (Research Centre in Food Toxicology), Universitè de Toulouse, ENVT, INP-Purpan, UPS, Toulouse, France.

Jildau Bowman (J)

Netherlands Organisation for Applied Scientific Research (TNO) Research group: Microbiology and Systems Biology (MSB), Amsterdam, The Netherlands.

Philippe Gerard (P)

Micalis Institute, INRA, AgroParisTech, Université Paris-Saclay, Jouy-en-Josas, France.

Vincenzo Longo (V)

Institute of Agricultural Biology and Biotechnology (IBBA), National Research Council (CNR), Pisa, Italy.

Lisa Giovannelli (L)

Department of Neuroscience, Psychology, Drug Research and Children's Health, University of Florence, Florence, Italy.

Giovanna Caderni (G)

Department of Neuroscience, Psychology, Drug Research and Children's Health, University of Florence, Florence, Italy.

Carlotta de Filippo (C)

Institute of Agricultural Biology and Biotechnology (IBBA), National Research Council (CNR), Pisa, Italy.

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Classifications MeSH