Facilitated Vegan Diet on Cardiometabolic Endpoints and Trimethylamine N-oxide

Status unconfirmed · Not applicable

Conditions studied: Cardiometabolic Risk Factors

In brief

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.

Key facts

Study ID

NCT05071196

Run by

David Grant U.S. Air Force Medical Center

People needed

70

Starts

2022-01-01

Expected to finish

2022-06-01

Last updated by the study team

2022-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• David Grant U.S. Air Force Medical Center — Travis Air Force Base, California, United States

Full record on ClinicalTrials.gov

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