Plant-Based Meat vs Animal "Red" Meat Trial (FOOD-1)

August 3, 2023 updated by: Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre

Plant-Based Meat vs Animal "Red" Meat: a Randomized Cross-over Trial

To assess the changes in the circulating levels of TMAO after 1-week of beef or plant-based burger diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Single-center, randomized, single-blinded cross-over trial including healthy adult participants (N=40, omnivores, aged between 25 and 65 years, and with a body mass index (BMI) between 20 and 40 kg/m2 (see participation criteria below). Participants will be randomized to either red meat (cow burger) or plant "meat" (plant-based burger). The primary outcome will be the within-group change in the TMAO levels.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥ 25 years and ≤65 of age
  • BMI ≥20 Kg/m2 and ≤40 Kg/m2
  • No known kidney disease
  • No antibiotics in the previous 30 days

Exclusion Criteria:

  • Any person who does not meet the above criteria and/or who refuses to participate
  • Food allergies (specific ingredients contained in the patties)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Red meat patties
Participants will be randomized to group 1: Red meat, ''Costco Kirkland Signature 1/4 lb Ground Beef Patties'' (Beef burger). Participants will be given two patties per day.
Other: Red meat patties group

1. Baseline Visit: day -7 before randomization

  • Clinical history
  • Refrain from seafood, eggs, fish or meat, for 7-day ("washout") prior to Day 1. 2. Day 1 Randomization
  • Randomization to 1 of 2 interventions: plant-based or meat burgers
  • 6 days-worth of burgers will be delivered to the participant's house 3. Day 1-6:
  • The participant will be asked to eat a specific randomized diet for 6 days 5. Days 7
  • Physical exam (weight, BP, HR)
  • Food questionnaire
  • Blood draw: Circulating TMAO, Total, LDL, and HDL cholesterol, Creatinine, High-sensitivity c-reactive protein
  • Urine Collection - TMAO 6. Day 7-14: Washout 7. Day 14: Patties delivery 8. Day 14-20: Assigned diet for 6 days 9. Days 20: Same as day 7
Experimental: Plant-based patties
Participants will be randomized to group 2: plant-based burger which contains no animal products. The Plant-based burger selected is ''Beyond Burger" (https://www.beyondmeat.com/products/the-beyond-burger/ ). Participants will be given two patties per day.
Other: Plant-based patties group
Same as above

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TMAO levels
Time Frame: Baseline Day 6-7-20-21
Blood and urine analysis will be performed to determine TMAO levels after each intervention
Baseline Day 6-7-20-21

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total, LDL, and HDL cholesterol
Time Frame: Baseline Day 6-7-20-21
Blood and urine analysis will be performed to determine cholesterol levels after each intervention
Baseline Day 6-7-20-21
Change in high-sensitivity c-reactive protein
Time Frame: Baseline Day 6-7-20-21
Blood and urine analysis will be performed to determine c-reactive protein levels after each intervention
Baseline Day 6-7-20-21
Change in systolic and diastolic blood pressure
Time Frame: Baseline Day 6-7-20-21
Assessment of blood pressure
Baseline Day 6-7-20-21
Change in heart rate
Time Frame: Baseline Day 6-7-20-21
Assessment of heart rate
Baseline Day 6-7-20-21

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence of diet
Time Frame: Baseline Day 6-7-20-21
Self-reported completion of dietary intervention
Baseline Day 6-7-20-21
Tolerance of diet
Time Frame: Baseline Day 6-7-20-21
Self-reported tolerance of dietary intervention
Baseline Day 6-7-20-21
Identification of study intervention
Time Frame: Baseline Day 6-7-20-21
Self-reported identification of dietary intervention
Baseline Day 6-7-20-21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

João Pedro Ferreira, MD

Investigators

  • Principal Investigator: Abhinav Sharma, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-6374

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The coded data will be securely shared with Dr. João Pedro Ferreira at the University of Lorraine, Clinical Research Center of Nancy in France.

IPD Sharing Time Frame

Undetermined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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