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Meat-based Versus Pesco-vegetarian Diet and Colorectal Cancer (MeaTIc)

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ClinicalTrials.gov Identifier: NCT03416777
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi

Brief Summary:
Colorectal cancer (CRC) is strongly affected by diet, with red and processed meat increasing risk. To understand the role of microbiome in this phenomenon and to identify specific microbiome/metabolomics profiles associated with CRC risk, will be studied: 1) healthy volunteers fed for 3 months with: a high-CRC risk diet (meat-based MBD), a normalized CRC risk diet (MBD plus alpha-tocopherol, MBD-T), a low-CRC risk diet (pesco-vegetarian, PVD). At the beginning and at the end of the intervention, gut microbiome profiles (metagenomics and metabolomics), and CRC biomarkers (genotoxicity, cytotoxicity, peroxidation in faecal water; lipid/glycemic indexes, inflammatory cytokines, oxidative stress), 2) Colon carcinogenesis: the same diets will be fed (3 months) to carcinogen-induced rats or to Pirc rats, mutated in Apc, the key gene in CRC; faecal microbiome profiles, will be correlated to carcinogenesis measuring preneoplastic lesions, colon tumours, and faecal and blood CRC biomarkers as in humans; 3) To further elucidate the mechanisms underlying the effect of different microbiomes in determining CRC risk, faeces from rats fed the experimental diets will be transplanted into carcinogen-induced germ-free rats, measuring how microbiome changes correlate with metabolome and disease outcomes. The results will provide fundamental insight in the role of microbiome in determining the effect of the diet, in particular red/processed meat intake, on CRC risk

Condition or disease Intervention/treatment Phase
Nutrition Aspect of Cancer Diet Modification Cancer of Colon Behavioral: Meat-based diet Dietary Supplement: Meat-based diet supplemented with alpha-tocopherol (MBD-T) Behavioral: Pesco-vegetarian diet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel open dietary intervention study with 3 arms of intervention
Masking: None (Open Label)
Masking Description: In this trial blinding of participants and investigators will not be possible because of obvious differences between the intervention diets
Primary Purpose: Prevention
Official Title: Faecal Microbiome as Determinant of the Effect of Diet on Colorectal-cancer Risk: Comparison of Meat Based Versus Pesco-vegetarian Diets (MeaTIc)
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Meat-based diet (MBD)
Behavioral intervention with diet including 4 servings per week of red meat, 3 servings per week of processed meat, and 1 servings per week of poultry, for a total amount of 900 g per week of meat.
Behavioral: Meat-based diet
Diet including 4 servings per week of red meat (1 serving = 150 g), 3 servings per week of processed meat (1 serving = 50 g), and 1 servings per week of poultry (1 serving = 150 g), for a total amount of 900 g per week of meat.
Other Name: MBD

Experimental: Meat-based alpha-tocopherol (MBD-T)
Behavioral intervention including diet with 4 servings per week of red meat, 3 servings per week of processed meat, and 1 servings per week of poultry, for a total amount of 900 g per week of meat with a dietary supplement of 100 mg/day of alpha-tocopherol in the form of tablet
Dietary Supplement: Meat-based diet supplemented with alpha-tocopherol (MBD-T)
Dietary intervention like the MBD with supplementation of alpha-tocopherol at a dosage of 100 mg/die. Available evidence suggests that alpha-tocopherol may help prevent colon cancer by decreasing the formation of mutagens arising from the oxidation of faecal lipids, by decreasing oxidative stress in the epithelial cells of the colon and by molecular mechanisms that influence cell death, cell cycle and transcriptional events (Pierre 2013, Bastide 2016, Bastide 2017, Diallo 2016). It is important to note that 200 mg/day of tocopherol was administered to 20,000 women for 10 years without side effects (Lee et al.,2005).
Other Name: MBD-T

Experimental: Pesco-vegetarian (PVD)
Behavioral intervention with diet excluding fresh and processed meat, poultry but including 3 servings per week of any type of fish, excluding shellfish
Behavioral: Pesco-vegetarian diet
Diet excluding fresh and processed meat, poultry but including 3 servings per week of any type of fish, excluding shellfish (1 serving = 150 g), for a total amount of 450 g per week. Diet will contain other sources of proteins (e.g. eggs, dairy, legumes/beans). There is suggestive evidence that fish and vegetable consumption has protective effects against CRC (Vieira et al., 2017).
Other Name: PVD




Primary Outcome Measures :
  1. DNA damage [ Time Frame: 3 months ]
    Decrease (<25%) of DNA damage by faecal water (genotoxicity), using comet assay in a cellular model


Secondary Outcome Measures :
  1. Microbiome and metabolomics profiles [ Time Frame: 3 months ]
    Changes of microbiome and the relative metabolomics profiles from baseline

  2. Peroxidation [ Time Frame: 3 months ]
    Global and specific peroxidation of omega-3 and omega-6 of the faecal water change from baseline

  3. Inflammatory parameters [ Time Frame: 3 months ]
    Pro- and anti-inflammatory profile's change from baseline

  4. Oxidative stress [ Time Frame: 3 months ]
    Oxidative stress profile's change from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinically healthy (both sexes)
  • age >18 years and ≤ 50 years.

The study population will be selected with an age ranging from 18 to 50 years because after 50 years the risk for CRC shows a significant increase in incidence. In fact, more than 90% of the people diagnosed with the disease are older than 50, with the average age at the time of diagnosis being 64 (Amersi et al., 2005). With respect to gender, its role in the development of colorectal cancer remains unclear (Amersi et al., 2005).

Exclusion Criteria:

  • Presence of current illness or unstable conditions
  • Current or recent (past 2 months) use of antibiotics or probiotics
  • Pregnancy or intention to become pregnant in the next 12 months or lactation
  • Current smoking habit
  • Current or recent (past 2 months) adoption of a vegetarian diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416777


Contacts
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Contact: Francesco Sofi, MD +39 0557946509 francesco.sofi@unifi.it

Locations
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Italy
Unit of Clinical Nutrition, University Hospital of Careggi Recruiting
Florence, Italy, 50134
Contact: Francesco Sofi, MD, PhD       francesco.sofi@unifi.it   
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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Study Director: Alessandro Casini, MD University of Florence
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francesco Sofi, Associate Professor of Clinical Nutrition, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT03416777    
Other Study ID Numbers: MeaTIC-INTIMIC
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Sofi, Azienda Ospedaliero-Universitaria Careggi:
vegetarian
meat
fish
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Tocopherols
Vitamin E
Tocotrienols
alpha-Tocopherol
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Nutrients
Growth Substances