Clinical trial NCT04510324: Plant-Based Meat vs Animal "Red" Meat Trial
Official title: Plant-Based Meat vs Animal "Red" Meat: a Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Keywords: TMAO
Red meat
Plant-base nutrition
Cardiovascular diseases
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: João Pedro Ferreira, MD
First posted: 2020-08-12
Enrollment: 41
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in TMAO levels
timeFrame: Baseline Day 6-7-20-21
Secondary outcomes:
measure: Change in total, LDL, and HDL cholesterol
timeFrame: Baseline Day 6-7-20-21
measure: Change in high-sensitivity c-reactive protein
timeFrame: Baseline Day 6-7-20-21
measure: Change in systolic and diastolic blood pressure
timeFrame: Baseline Day 6-7-20-21
measure: Change in heart rate
timeFrame: Baseline Day 6-7-20-21
Other outcomes:
measure: Adherence of diet
timeFrame: Baseline Day 6-7-20-21
measure: Tolerance of diet
timeFrame: Baseline Day 6-7-20-21
measure: Identification of study intervention
timeFrame: Baseline Day 6-7-20-21
Locations:
city: Montreal
country: Canada
facility: McGill University health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Abhinav Sharma, MD
role: PRINCIPAL_INVESTIGATOR
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