Inflammatory Response
Conditions
Keywords
TMAO, Red meat, Plant-base nutrition, Cardiovascular diseases
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.
Interventions
OTHERRed 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
OTHERPlant-based patties group
Same as above
Sponsors
João Pedro Ferreira, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
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).
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change in systolic and diastolic blood pressure | Baseline Day 6-7-20-21 | Assessment of blood pressure |
| Change in heart rate | Baseline Day 6-7-20-21 | Assessment of heart rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence of diet | Baseline Day 6-7-20-21 | Self-reported completion of dietary intervention |
| Identification of study intervention | Baseline Day 6-7-20-21 | Self-reported identification of dietary intervention |
| Tolerance of diet | Baseline Day 6-7-20-21 | Self-reported tolerance of dietary intervention |
Countries
Canada
Outcome results
None listed