Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide

Cardiometabolic Risk Factors Clinical Trial

Official title:

Impact of Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05071196
• Other study ID #: FWH20210097H
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: March 2022
• Source: David Grant U.S. Air Force Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vegan meal kit delivery offers consumer convenience and has shown benefit in cardiometabolic parameters such as low-density lipoprotein cholesterol (LDL-c) and weight. The purpose of this study is to evaluate the impact of meal kit facilitated vegan diet on LDL-c and trimethylamine N-oxide (TMAO) when compared to an omnivorous diet control.

Description:

This study will compare the impact of a vegan diet to a non-vegan diet, when provided with meal kits in participants who are overweight.

A vegan diet includes foods that come from plants and excludes foods that come from animals like meat, dairy, and eggs. Dietary modifications such as adopting a vegan diet are associated with significant improvements in cardiometabolic parameters, making it one of the preferred treatment options for obesity and preventing associated health conditions. Meal kits are packages that include: a quick (~30-45 minutes) and simple recipe, all the recipe's required ingredients, and are conveniently delivered to patient homes. In this study, a facilitated vegan diet is defined as a change from an omnivorous diet to a vegan diet with the aid of boxed vegan meal kit delivery. A facilitated vegan diet has shown LDL-c and weight improvements over continuing an omnivorous diet in a preliminary study.

TMAO, changes in gut microbiome, and compliance to dietary modification impact cardiovascular and overall health. TMAO is a diet dependent biomarker for CVD, as elevated TMAO levels are associated with a 62% increased risk of heart attack, stroke, or death. TMAO increases platelet hyperactivity, inflammation, and foam cell generation, all of which contribute to atherosclerosis and may explain the increased risk of CVD. Additionally, TMAO predicts risk of major adverse cardiovascular events independently of other cardiovascular risk factors.

Consumption of animal products elevate TMAO levels due to its abundance of TMAO precursors:

choline and carnitine. Chronic dietary red meat was associated with increased TMAO levels over white meat and non-meat protein. One study found that consuming plant-based alternative meat products improved TMAO levels over a mostly red meat diet. Both study interventions replaced protein sources but did not remove animal products such as eggs and dairy, which have conflicting evidence relative to TMAO. This study intervention will have participants adopt a full vegan diet, eliminating animal products.

The gut microbiome plays a crucial role in converting dietary precursors into TMAO. TMAO levels post l-carnitine ingestion were significantly higher in patients on a long-term omnivorous diet vs patients on a long-term vegan or vegetarian diet. This suggests that the gut microbiome in a plant-based diet lowers the formation of TMAO via the diet. This study will explore changes in gut microbiome from a dietary intervention in relation to TMAO and explore if these changes are sustained after discontinuing a 4-week facilitated vegan diet. Additionally, changes in gut microbiome will be explored in relation to microbiota changes seen in other disease states such as anxiety, irritable bowel disease, and other inflammatory diseases.

The impact of dietary modifications on controlling obesity and associated health conditions has room for improvement. Dietary modifications have long been one of the preferred treatments in obesity and CVD prevention, yet the obesity rates continue to rise. One potential area of improvement is compliance to dietary modification. This study will explore changes in food group restricted free diet patterns after a 4-week vegan meal kit intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years old

• BMI = 25kg/m^2

• Consume = 5 servings red meat per week

• Active duty military and Department of Defense (DoD) Beneficiaries with active Tricare insurance

• Willing and able to adopt a vegan or standard omnivorous diet for 4 weeks

• Willing and able to track meal patterns, nutritional intake, exercise activity, and adverse events for 13 weeks

• Willing and able to come to David Grant USAF Medical Center for 4 blood draws

• Able to receive weekly emails and receive and prepare meal kits

Exclusion Criteria:

• Currently on a vegetarian, vegan, or food-group restricted diet

• Currently taking or planning to initiate medications or supplements that significantly affect TMAO levels, carnitine, choline, or gut microbiome (Systemic antibiotics, antifungals, antivirals, antiparasitic, corticosteroids, methotrexate, cytokines, or immunosuppressive cytotoxic agents, laxatives, proton pump inhibitors, resveratrol, meldonium, or metformin)

• Currently consuming the following = 2 times per week: probiotics/prebiotics, probiotic enhanced foods (eg. enhanced yogurt, kefir, kombucha), or energy drinks, multivitamins, or supplements with choline, carnitine, or betaine (Acceptable to consume: non-probiotic enhanced yogurts, energy drinks and multivitamins without choline, carnitine, or betaine)

• Participants will have the option to delay study start if they express interest in the study and have permanently discontinued one of the excluded diet, medication, or supplement listed previously within the past 4 weeks (minimum 4 week time between discontinuation of excluded item and study start)

• Clinically significant or unstable cardiovascular, gastrointestinal, hepatic, or renal disease states defined as requiring on-going changes to medication or medical management

• Consumption of smoking or chewing tobacco, or other nicotine-containing products for >1 day per week

• Consumption of >14 alcohol drinks per week

• Pregnant, breastfeeding, or plan to become pregnant

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors

Intervention

Other:
• Facilitated Vegan Diet
Vegan boxed meal kits
• Omnivorous Diet
Non-vegan boxed meal kits

Locations

Country	Name	City	State
United States	David Grant U.S. Air Force Medical Center	Travis Air Force Base	California

Sponsors (1)

Lead Sponsor	Collaborator
David Grant U.S. Air Force Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Crimarco A, Springfield S, Petlura C, Streaty T, Cunanan K, Lee J, Fielding-Singh P, Carter MM, Topf MA, Wastyk HC, Sonnenburg ED, Sonnenburg JL, Gardner CD. A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT). Am J Clin Nutr. 2020 Nov 11;112(5):1188-1199. doi: 10.1093/ajcn/nqaa203. — View Citation

Heianza Y, Ma W, Manson JE, Rexrode KM, Qi L. Gut Microbiota Metabolites and Risk of Major Adverse Cardiovascular Disease Events and Death: A Systematic Review and Meta-Analysis of Prospective Studies. J Am Heart Assoc. 2017 Jun 29;6(7). pii: e004947. doi: 10.1161/JAHA.116.004947. Review. — 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

Najjar RS, Moore CE, Montgomery BD. A defined, plant-based diet utilized in an outpatient cardiovascular clinic effectively treats hypercholesterolemia and hypertension and reduces medications. Clin Cardiol. 2018 Mar;41(3):307-313. doi: 10.1002/clc.22863. Epub 2018 Mar 25. — 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

The Vegan Diet. National Health Service website. Updated Aug 2018. Accessed 10 Jan 2021.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference between intervention arms in baseline adjusted gut microbiome at 4 weeks	Change in alpha diversity	4 weeks
Other	Change between intervention arms in baseline adjusted gut microbiome at 8 weeks	Change in alpha diversity	8 weeks
Other	Change between intervention arms in baseline adjusted gut microbiome at 12 weeks	Change in alpha diversity	12 weeks
Other	Change between intervention arms in baseline adjusted complete blood count	Change in complete blood count	12 weeks
Other	Change between intervention arms in baseline adjusted serum C-reactive protein	Change in C-reactive protein	12 weeks
Other	Change between intervention arms in baseline adjusted serum high sensitivity C-reactive protein	Change in high sensitivity C-reactive protein	12 weeks
Other	Change between intervention arms in baseline adjusted serum vitamin B12 level	Change in vitamin B12	12 weeks
Other	Change between intervention arms in baseline adjusted serum iron	Change in serum iron	12 weeks
Other	Change in calorie intake	Change in calorie intake	12 weeks
Other	Change in meal patterns post vegan meal kit intervention	Change in percent of vegan meals per week	12 weeks
Primary	Change between intervention arms in baseline adjusted LDL-c at 4 weeks	Change in LDL-c	4 weeks
Primary	Change between intervention arms in baseline adjusted TMAO at 4 weeks	Change in TMAO	4 weeks
Secondary	Change between intervention arms in baseline adjusted LDL-c at 8 weeks	Change in LDL-c	8 weeks
Secondary	Change between intervention arms in baseline adjusted LDL-c at 12 weeks	Change in LDL-c	12 weeks
Secondary	Change between intervention arms in baseline adjusted TMAO at 8 weeks	Change in TMAO	8 weeks
Secondary	Change between intervention arms in baseline adjusted TMAO at 12 weeks	Change in TMAO	12 weeks
Secondary	Change between intervention arms in baseline adjusted lipid panel parameters at 4 weeks	Change in lipid panel	4 weeks
Secondary	Change between intervention arms in baseline adjusted lipid panel parameters at 8 weeks	Change in lipid panel	8 weeks
Secondary	Change between intervention arms in baseline adjusted lipid panel parameters at 12 weeks	Change in lipid panel	12 weeks
Secondary	Change between intervention arms in baseline adjusted BMI at 4 weeks	Weight and height will be combined to report BMI in kg/m^2	4 weeks
Secondary	Change between intervention arms in baseline adjusted BMI at 8 weeks	Weight and height will be combined to report BMI in kg/m^2	8 weeks
Secondary	Change between intervention arms in baseline adjusted BMI at 12 weeks	Weight and height will be combined to report BMI in kg/m^2	12 weeks
Secondary	Change between intervention arms in baseline adjusted blood pressure at 4 weeks	Measured with Sphygmocor device, both systolic and diastolic blood pressures	4 weeks
Secondary	Change between intervention arms in baseline adjusted blood pressure at 8 weeks	Measured with Sphygmocor device, both systolic and diastolic blood pressures	8 weeks
Secondary	Change between intervention arms in baseline adjusted blood pressure at 12 weeks	Measured with Sphygmocor device, both systolic and diastolic blood pressures	12 weeks
Secondary	Change between intervention arms in baseline adjusted hemoglobin A1c at 4 weeks	Change in hemoglobin A1c	4 weeks
Secondary	Change between intervention arms in baseline adjusted hemoglobin A1c at 8 weeks	Change in hemoglobin A1c	8 weeks
Secondary	Change between intervention arms in baseline adjusted hemoglobin A1c at 12 weeks	Change in hemoglobin A1c	12 weeks