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

Stanford University

Status: Completed

Conditions: Microbiome; Cardiovascular Diseases; Immune Function

Treatments: Behavioral: Plant Alternative products; Behavioral: Meat products

Study type: Interventional

Funder types: Other

Identifiers

NCT03718988

48285

Details and patient eligibility

About

This study aims to investigate the impact of replacing meat consumption with plant-based meat alternative consumption on cardiovascular health, the gut microbiome, and metabolic status.

Full description

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Meat Phase first

Experimental group

Description:

Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.

Treatment:

Behavioral: Meat products

Behavioral: Plant Alternative products

Plant Alternative Phase first

Experimental group

Description:

Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.

Treatment:

Behavioral: Meat products

Behavioral: Plant Alternative products