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Completed

NCT Number: NCT04510324

Plant-Based Meat vs Animal "Red" Meat Trial

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

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Key information

Conditions

Inflammatory Response Cardiovascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University health Center

Montreal, Quebec, H4A 3J1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Red meat patties group

Other
  • 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

Plant-based patties group

Other

Same as above

Primary outcomes

  1. Change in TMAO levels

    Time frame: Baseline Day 6-7-20-21

    Blood and urine analysis will be performed to determine TMAO levels after each intervention

Secondary outcomes

  1. Change in total, LDL, and HDL cholesterol

    Time frame: Baseline Day 6-7-20-21

    Blood and urine analysis will be performed to determine cholesterol levels after each intervention

  2. Change in high-sensitivity c-reactive protein

    Time frame: Baseline Day 6-7-20-21

    Blood and urine analysis will be performed to determine c-reactive protein levels after each intervention

  3. Change in systolic and diastolic blood pressure

    Time frame: Baseline Day 6-7-20-21

    Assessment of blood pressure

  4. Change in heart rate

    Time frame: Baseline Day 6-7-20-21

    Assessment of heart rate

Other outcomes

  1. Adherence of diet

    Time frame: Baseline Day 6-7-20-21

    Self-reported completion of dietary intervention

  2. Tolerance of diet

    Time frame: Baseline Day 6-7-20-21

    Self-reported tolerance of dietary intervention

  3. Identification of study intervention

    Time frame: Baseline Day 6-7-20-21

    Self-reported identification of dietary intervention

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Collaborators

  • João Pedro Ferreira, MD

Registry information

Official study title

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

Acronym: FOOD-1

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2020
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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