Plant-Based Meat vs Animal "Red" Meat Trial

Not Applicable

Completed

• Conditions: Inflammatory Response

• Registration Number: NCT04510324
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-12
• Study Start: 2020-11-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in heart rate	Baseline Day 6-7-20-21	Assessment of heart rate
Change in systolic and diastolic blood pressure	Baseline Day 6-7-20-21	Assessment of blood pressure
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
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

Trial Locations

Locations (1)

McGill University health Center; 🇨🇦 Montreal, Quebec, Canada