NCT04510324

Plant-Based Meat vs Animal "Red" Meat Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Inflammatory Response

Interventions

Type	Name	Description
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
OTHER	Plant-based patties group	Same as above

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2020-08-12
• Last updated: 2023-08-07

Locations

1 site across 1 country: Canada