Plant-Based Meat vs Animal "Red" Meat Trial

NCT04510324 | Completed

• 1 other identifier: 2020-6374
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Response

Keywords

TMAO; Red meat; Plant-base nutrition; Cardiovascular diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in total, LDL, and HDL cholesterol

  Baseline Day 6-7-20-21

• Change in high-sensitivity c-reactive protein

  Baseline Day 6-7-20-21

• Change in systolic and diastolic blood pressure

  Baseline Day 6-7-20-21

• Change in heart rate

  Baseline Day 6-7-20-21

Other Outcomes (3)

• Adherence of diet

  Baseline Day 6-7-20-21

• Tolerance of diet

  Baseline Day 6-7-20-21

• Identification of study intervention

  Baseline Day 6-7-20-21

Study Arms (2)

Red meat patties

ACTIVE COMPARATOR

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

Plant-based patties

EXPERIMENTAL

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

Interventions

Red meat patties group OTHER

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

Red meat patties

Plant-based patties group OTHER

Same as above

Plant-based patties

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Any person who does not meet the above criteria and/or who refuses to participate
• Food allergies (specific ingredients contained in the patties)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• João Pedro Ferreira, MD: collaborator

Study Sites (1)

McGill University health Center

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (15)

• Wang Z, Klipfell E, Bennett BJ, Koeth R, Levison BS, Dugar B, Feldstein AE, Britt EB, Fu X, Chung YM, Wu Y, Schauer P, Smith JD, Allayee H, Tang WH, DiDonato JA, Lusis AJ, Hazen SL. Gut flora metabolism of phosphatidylcholine promotes cardiovascular disease. Nature. 2011 Apr 7;472(7341):57-63. doi: 10.1038/nature09922.

  PMID: 21475195 BACKGROUND

• Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.

  PMID: 23614584 BACKGROUND

• Schiattarella GG, Sannino A, Toscano E, Giugliano G, Gargiulo G, Franzone A, Trimarco B, Esposito G, Perrino C. Gut microbe-generated metabolite trimethylamine-N-oxide as cardiovascular risk biomarker: a systematic review and dose-response meta-analysis. Eur Heart J. 2017 Oct 14;38(39):2948-2956. doi: 10.1093/eurheartj/ehx342.

  PMID: 29020409 BACKGROUND

• Bennett BJ, de Aguiar Vallim TQ, Wang Z, Shih DM, Meng Y, Gregory J, Allayee H, Lee R, Graham M, Crooke R, Edwards PA, Hazen SL, Lusis AJ. Trimethylamine-N-oxide, a metabolite associated with atherosclerosis, exhibits complex genetic and dietary regulation. Cell Metab. 2013 Jan 8;17(1):49-60. doi: 10.1016/j.cmet.2012.12.011.

  PMID: 23312283 BACKGROUND

• Warrier M, Shih DM, Burrows AC, Ferguson D, Gromovsky AD, Brown AL, Marshall S, McDaniel A, Schugar RC, Wang Z, Sacks J, Rong X, Vallim TA, Chou J, Ivanova PT, Myers DS, Brown HA, Lee RG, Crooke RM, Graham MJ, Liu X, Parini P, Tontonoz P, Lusis AJ, Hazen SL, Temel RE, Brown JM. The TMAO-Generating Enzyme Flavin Monooxygenase 3 Is a Central Regulator of Cholesterol Balance. Cell Rep. 2015 Jan 20;10(3):326-338. doi: 10.1016/j.celrep.2014.12.036. Epub 2015 Jan 15.

  PMID: 25600868 BACKGROUND

• Wang Z, Roberts AB, Buffa JA, Levison BS, Zhu W, Org E, Gu X, Huang Y, Zamanian-Daryoush M, Culley MK, DiDonato AJ, Fu X, Hazen JE, Krajcik D, DiDonato JA, Lusis AJ, Hazen SL. Non-lethal Inhibition of Gut Microbial Trimethylamine Production for the Treatment of Atherosclerosis. Cell. 2015 Dec 17;163(7):1585-95. doi: 10.1016/j.cell.2015.11.055.

  PMID: 26687352 BACKGROUND

• Roberts AB, Gu X, Buffa JA, Hurd AG, Wang Z, Zhu W, Gupta N, Skye SM, Cody DB, Levison BS, Barrington WT, Russell MW, Reed JM, Duzan A, Lang JM, Fu X, Li L, Myers AJ, Rachakonda S, DiDonato JA, Brown JM, Gogonea V, Lusis AJ, Garcia-Garcia JC, Hazen SL. Development of a gut microbe-targeted nonlethal therapeutic to inhibit thrombosis potential. Nat Med. 2018 Sep;24(9):1407-1417. doi: 10.1038/s41591-018-0128-1. Epub 2018 Aug 6.

  PMID: 30082863 BACKGROUND

• Koeth RA, Wang Z, Levison BS, Buffa JA, Org E, Sheehy BT, Britt EB, Fu X, Wu Y, Li L, Smith JD, DiDonato JA, Chen J, Li H, Wu GD, Lewis JD, Warrier M, Brown JM, Krauss RM, Tang WH, Bushman FD, Lusis AJ, Hazen SL. Intestinal microbiota metabolism of L-carnitine, a nutrient in red meat, promotes atherosclerosis. Nat Med. 2013 May;19(5):576-85. doi: 10.1038/nm.3145. Epub 2013 Apr 7.

  PMID: 23563705 BACKGROUND

• Conlon MA, Bird AR. The impact of diet and lifestyle on gut microbiota and human health. Nutrients. 2014 Dec 24;7(1):17-44. doi: 10.3390/nu7010017.

  PMID: 25545101 BACKGROUND

• Miller CA, Corbin KD, da Costa KA, Zhang S, Zhao X, Galanko JA, Blevins T, Bennett BJ, O'Connor A, Zeisel SH. Effect of egg ingestion on trimethylamine-N-oxide production in humans: a randomized, controlled, dose-response study. Am J Clin Nutr. 2014 Sep;100(3):778-86. doi: 10.3945/ajcn.114.087692. Epub 2014 Jun 18.

  PMID: 24944063 BACKGROUND

• Koeth RA, Lam-Galvez BR, Kirsop J, Wang Z, Levison BS, Gu X, Copeland MF, Bartlett D, Cody DB, Dai HJ, Culley MK, Li XS, Fu X, Wu Y, Li L, DiDonato JA, Tang WHW, Garcia-Garcia JC, Hazen SL. l-Carnitine in omnivorous diets induces an atherogenic gut microbial pathway in humans. J Clin Invest. 2019 Jan 2;129(1):373-387. doi: 10.1172/JCI94601. Epub 2018 Dec 10.

  PMID: 30530985 BACKGROUND

• Wang Z, Bergeron N, Levison BS, Li XS, Chiu S, Jia X, Koeth RA, Li L, Wu Y, Tang WHW, Krauss RM, Hazen SL. Impact of chronic dietary red meat, white meat, or non-meat protein on trimethylamine N-oxide metabolism and renal excretion in healthy men and women. Eur Heart J. 2019 Feb 14;40(7):583-594. doi: 10.1093/eurheartj/ehy799.

  PMID: 30535398 BACKGROUND

• Mertens E, Markey O, Geleijnse JM, Givens DI, Lovegrove JA. Dietary Patterns in Relation to Cardiovascular Disease Incidence and Risk Markers in a Middle-Aged British Male Population: Data from the Caerphilly Prospective Study. Nutrients. 2017 Jan 18;9(1):75. doi: 10.3390/nu9010075.

  PMID: 28106791 BACKGROUND

• Taesuwan S, Cho CE, Malysheva OV, Bender E, King JH, Yan J, Thalacker-Mercer AE, Caudill MA. The metabolic fate of isotopically labeled trimethylamine-N-oxide (TMAO) in humans. J Nutr Biochem. 2017 Jul;45:77-82. doi: 10.1016/j.jnutbio.2017.02.010. Epub 2017 Apr 13.

  PMID: 28433924 BACKGROUND

• Janeiro MH, Ramirez MJ, Milagro FI, Martinez JA, Solas M. Implication of Trimethylamine N-Oxide (TMAO) in Disease: Potential Biomarker or New Therapeutic Target. Nutrients. 2018 Oct 1;10(10):1398. doi: 10.3390/nu10101398.

  PMID: 30275434 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Abhinav Sharma, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: November 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Undetermined

Locations

CA (1)