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FOOD-1: Plant-Based Meat vs Animal "Red" Meat Trial

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT04510324
Collaborator
João Pedro Ferreira, MD (Other)
40
Enrollment
1
Location
2
Arms
25.9
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Red meat patties group
  • Other: Plant-based patties group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model 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). Following one week of a meat, egg, and seafood free diet ('washout'), participants will be randomized to either red meat (cow burger) or plant meat (plant-based burger) for one week. Following this, participants will under go another week of diet washout and will then be crossed over to the other meat burger for one week. The primary outcome will be the within-group change in the TMAO levels.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). Following one week of a meat, egg, and seafood free diet ('washout'), participants will be randomized to either red meat (cow burger) or plant meat (plant-based burger) for one week. Following this, participants will under go another week of diet washout and will then be crossed over to the other meat burger for one week. The primary outcome will be the within-group change in the TMAO levels.
Masking:
Single (Participant)
Masking Description:
Patients will be randomized in a 1:1 ratio. Randomization will be performed within the electronic database system at the time of enrollment using a random number generator, an approach we have used successfully in other clinical trials. The participants will be blinded to the intervention assignment (single blinded study).
Primary Purpose:
Other
Official Title:
Plant-Based Meat vs Animal "Red" Meat: a Randomized Cross-over Trial
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in TMAO levels [Baseline Day 6-7-20-21]

    Blood and urine analysis will be performed to determine TMAO levels after each intervention

Secondary Outcome Measures

  1. Change in total, LDL, and HDL cholesterol [Baseline Day 6-7-20-21]

    Blood and urine analysis will be performed to determine cholesterol levels after each intervention

  2. Change in high-sensitivity c-reactive protein [Baseline Day 6-7-20-21]

    Blood and urine analysis will be performed to determine c-reactive protein levels after each intervention

  3. Change in systolic and diastolic blood pressure [Baseline Day 6-7-20-21]

    Assessment of blood pressure

  4. Change in heart rate [Baseline Day 6-7-20-21]

    Assessment of heart rate

Other Outcome Measures

  1. Adherence of diet [Baseline Day 6-7-20-21]

    Self-reported completion of dietary intervention

  2. Tolerance of diet [Baseline Day 6-7-20-21]

    Self-reported tolerance of dietary intervention

  3. Identification of study intervention [Baseline Day 6-7-20-21]

    Self-reported identification of dietary intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 McGill University health Center Montreal Quebec Canada H4A 3J1

Sponsors and Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • João Pedro Ferreira, MD

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Abhinav Sharma, Cardiologist, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT04510324
Other Study ID Numbers:
  • 2020-6374
First Posted:
Aug 12, 2020
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Abhinav Sharma, Cardiologist, McGill University Health Centre/Research Institute of the McGill University Health Centre
TMAO
Red meat
Plant-base nutrition
Cardiovascular diseases

Study Results

No Results Posted as of Jul 28, 2022