Plant-Based Meat vs Animal Red Meat Trial

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

Detailed Description
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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.

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

Conditions
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Inflammatory Response

Intervention / Treatment
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* Other: Red meat patties group
* Other: Plant-based patties group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Red meat patties<br>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<br>* 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<br>|
| Experimental: Plant-based patties<br>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<br>* Same as above<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TMAO levels | 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 | 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 | 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 | Assessment of blood pressure | Baseline Day 6-7-20-21 | 
| Change in heart rate | Assessment of heart rate | Baseline Day 6-7-20-21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMAO, Red meat, Plant-base nutrition, Cardiovascular diseases