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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Microbiome, Immune Function, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Meat products
* Behavioral: Plant Alternative products


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: SWAP-MEAT is a randomized, cross-over design among 30 adults randomly assigned to one of two diet sequences. Each diet sequence will consist of two phases: the Meat phase, which will consist of participants consuming their typical diet, and the Plant Alternative phase, which will consist of participants consuming plant-based meat alternatives instead of their typical meat products, for a predominantly vegetarian diet.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meat Phase first<br>Participants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks. | Behavioral: Meat products<br>* Traditional meat products (beef burger patties, pork sausage, etc.)<br>Behavioral: Plant Alternative products<br>* Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)<br>|
| Experimental: Plant Alternative Phase first<br>Participants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks. | Behavioral: Meat products<br>* Traditional meat products (beef burger patties, pork sausage, etc.)<br>Behavioral: Plant Alternative products<br>* Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trimethylamine N-oxide (TMAO). | Change from baseline in TMAO at 8 weeks. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin-like Growth Factor-1 (IGF-1) | Change from baseline in IGF-1 at 8 weeks. | Baseline and 8 weeks | 
| Microbiota composition | Change from baseline in alpha diversity at 8 weeks of each phase. We will be using number of observed sequence variants (species) determined by standard 16S rRNA amplicon sequencing (V3-V5 region followed by DADA2 to define error-corrected sequence variants) as our primary metric of alpha diversity. Higher alpha diversity is better. The units are the # of sequence variants. | Baseline and 8 weeks | 
| Microbiota function | Change from baseline in composite of short-chain fatty acids (SCFA) concentration (ug/g stool: acetate + propionate + butyrate) at 8 weeks of each phase. | Baseline and 8 weeks | 
| Total Cholesterol | Change from baseline in total cholesterol at 8 weeks of each phase. | Baseline and 8 weeks | 
| LDL Cholesterol | Change from baseline in LDL cholesterol at 8 weeks of each phase. | Baseline and 8 weeks | 
| HDL Cholesterol | Change from baseline in HDL cholesterol at 8 weeks of each phase. | Baseline and 8 weeks | 
| Triglycerides | Change from baseline in triglycerides at 8 weeks of each phase. | Baseline and 8 weeks | 
| Fasting glucose | Change from baseline in fasting glucose at 8 weeks of each phase. | Baseline and 8 weeks | 
| Fasting insulin | Change from baseline in fasting insulin at 8 weeks of each phase. | Baseline and 8 weeks | 
| Weight | Change from baseline in weight at 8 weeks of each phase. | Baseline and 8 weeks | 
| Waist circumference | Change from baseline in weight at 8 weeks of each phase. | Baseline and 8 weeks | 
| Blood pressure | Change from baseline in blood pressure at 8 weeks of each phase. | Baseline and 8 weeks |