To assess the changes in the circulating levels of TMAO after 1-week of beef or plant-based burger diet.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
41
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
Same as above
McGill University health Center
Montreal, Quebec, Canada
Change in TMAO levels
Blood and urine analysis will be performed to determine TMAO levels after each intervention
Time frame: Baseline Day 6-7-20-21
Change in total, LDL, and HDL cholesterol
Blood and urine analysis will be performed to determine cholesterol levels after each intervention
Time frame: Baseline Day 6-7-20-21
Change in high-sensitivity c-reactive protein
Blood and urine analysis will be performed to determine c-reactive protein levels after each intervention
Time frame: Baseline Day 6-7-20-21
Change in systolic and diastolic blood pressure
Assessment of blood pressure
Time frame: Baseline Day 6-7-20-21
Change in heart rate
Assessment of heart rate
Time frame: Baseline Day 6-7-20-21
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