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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2019-12-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Microbiome Immune Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Meat Phase first

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

Group Type EXPERIMENTAL

Meat products

Intervention Type BEHAVIORAL

Traditional meat products (beef burger patties, pork sausage, etc.)

Plant Alternative products

Intervention Type BEHAVIORAL

Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

Plant Alternative Phase first

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

Group Type EXPERIMENTAL

Meat products

Intervention Type BEHAVIORAL

Traditional meat products (beef burger patties, pork sausage, etc.)

Plant Alternative products

Intervention Type BEHAVIORAL

Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

Interventions

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Meat products

Traditional meat products (beef burger patties, pork sausage, etc.)

Intervention Type BEHAVIORAL

Plant Alternative products

Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes