Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide

NCT05071196 | Unknown

• 1 other identifier: FWH20210097H
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiometabolic Risk Factors

Keywords

Vegan; boxed meal kit; trimethylamine N-oxide; cardiometabolic

Outcome Measures

Primary Outcomes (2)

• Change between intervention arms in baseline adjusted LDL-c at 4 weeks

  Change in LDL-c

  4 weeks

• Change between intervention arms in baseline adjusted TMAO at 4 weeks

  Change in TMAO

  4 weeks

Secondary Outcomes (16)

• Change between intervention arms in baseline adjusted LDL-c at 8 weeks

  8 weeks

• Change between intervention arms in baseline adjusted LDL-c at 12 weeks

  12 weeks

• Change between intervention arms in baseline adjusted TMAO at 8 weeks

  8 weeks

• Change between intervention arms in baseline adjusted TMAO at 12 weeks

  12 weeks

• Change between intervention arms in baseline adjusted lipid panel parameters at 4 weeks

  4 weeks

Other Outcomes (10)

• Difference between intervention arms in baseline adjusted gut microbiome at 4 weeks

  4 weeks

• Change between intervention arms in baseline adjusted gut microbiome at 8 weeks

  8 weeks

• Change between intervention arms in baseline adjusted gut microbiome at 12 weeks

  12 weeks

Study Arms (2)

Facilitated Vegan Diet

EXPERIMENTAL

The facilitated vegan participants will self-prepare and consume 2 vegan meal kits per day for 4 weeks

Other: Facilitated Vegan Diet

Standard Omnivorous Diet

ACTIVE COMPARATOR

The standard omnivorous arm will self-prepare and consume 2 non-vegan meal kits per day for 4 weeks

Other: Omnivorous Diet

Interventions

Facilitated Vegan Diet OTHER

Vegan boxed meal kits

Facilitated Vegan Diet

Omnivorous Diet OTHER

Non-vegan boxed meal kits

Standard Omnivorous Diet

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

Study Sites (1)

David Grant U.S. Air Force Medical Center

Travis Air Force Base, California, 94535, United States

Location

Related Publications (7)

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

  BACKGROUND

• 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.

  PMID: 29575002 BACKGROUND

• 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):e004947. doi: 10.1161/JAHA.116.004947.

  PMID: 28663251 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

• 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

• 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.

  PMID: 32780794 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled, prospective clinical trial

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 8, 2021
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)