SWAP-MEAT: Study With Appetizing Plant Food - Meat Eating Alternatives Trial

Plant-based meat alternatives that closely emulate animal protein provide a new opportunity
to decrease meat consumption worldwide. Decreasing meat consumption and shifting to a
plant-based diet has been linked to improvements in physical health, including decreased risk
of cardiovascular disease, metabolic syndrome, and type 2 diabetes (Kahleova, Levin, &
Barnard, 2017). However, the extent to which plant-based meat alternatives specifically can
modulate biomarkers of physical health, particularly TMAO and IGF-1, and the gut microbiome
remain relatively unexplored. It is also largely unknown to what extent consumers can
feasibly and sustainably exchange meat products for plant-based meat alternatives for
extended periods of time. Plant-based meat alternatives offer a promising way to support
consumers' shift to a plant-based diet, and in turn, to potentially improve levels of TMAO
and IGF-1 and decrease cardiovascular risk. Thus, the investigators hypothesize that consumer
levels of TMAO and IGF-1 will be improved after 8 weeks of consuming plant-based meat
alternative products, as compared to 8 weeks of consuming traditional meat products.

Inclusion Criteria:

- Age ≥18

- Meat consumption (beef, pork/sausage, chicken) on average ≥ once a day

- Willing to consume meat (beef, pork/sausage, chicken) ≥ 2 times a day

Exclusion Criteria:

- Weight < 110 lb

- BMI ≥ 40

- LDL-C >190 mg/dL

- Systolic blood pressure (SBP) > 160 mmHg OR Diastolic blood pressure (DBP) > 90 mmHg

- Use of any of the following drugs/supplements within the last 2 months:

- systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous,
intramuscular, or oral);

- corticosteroids (intravenous, intramuscular, oral, nasal or inhaled);

- cytokines;

- methotrexate or immunosuppressive cytotoxic agents;

- Chronic, clinically significant, or unstable (unresolved, requiring on-going changes
to medical management or medication) pulmonary, cardiovascular, gastrointestinal,
hepatic or renal functional abnormality, as determined by medical history, Type 1
diabetes, dialysis.

- History of active cancer in the past 3 years except for squamous or basal cell
carcinomas of the skin that have been medically managed by local excision.

- Unstable dietary history as defined by major changes in diet during the previous
month, where the subject has eliminated or significantly increased a major food group
in the diet.

- Recent history of chronic excessive alcohol consumption defined as more than five
1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or
five 5-ounce servings of wine per day; or > 14 drinks/week.

- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency
(primary or acquired) including HIV infection, multiple sclerosis and Graves' disease.

- Regular/frequent use of smoking or chewing tobacco, e-cigarettes, cigars or other
nicotine-containing products.

- Regular use of prescription opiate pain medication