Plant-Based Meat vs Animal "Red" Meat Trial

Inflammatory Response Clinical Trial

— FOOD-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510324
• Other study ID #: 2020-6374
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

Other:
• Red 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
• Plant-based patties group
Same as above

Locations

Country	Name	City	State
Canada	McGill University health Center	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	João Pedro Ferreira, MD

Country where clinical trial is conducted

Canada, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence of diet	Self-reported completion of dietary intervention	Baseline Day 6-7-20-21
Other	Tolerance of diet	Self-reported tolerance of dietary intervention	Baseline Day 6-7-20-21
Other	Identification of study intervention	Self-reported identification of dietary intervention	Baseline Day 6-7-20-21
Primary	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	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
Secondary	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
Secondary	Change in systolic and diastolic blood pressure	Assessment of blood pressure	Baseline Day 6-7-20-21
Secondary	Change in heart rate	Assessment of heart rate	Baseline Day 6-7-20-21