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

February 18, 2023 updated by: Christopher Gardner, Stanford University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Meat products
Traditional meat products (beef burger patties, pork sausage, etc.)
Behavioral: Plant Alternative products
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)
Experimental: 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.
Behavioral: Meat products
Traditional meat products (beef burger patties, pork sausage, etc.)
Behavioral: Plant Alternative products
Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Trimethylamine N-oxide (TMAO).
Time Frame: Baseline and 8 weeks
Change from baseline in TMAO at 8 weeks.
Baseline and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin-like Growth Factor-1 (IGF-1)
Time Frame: Baseline and 8 weeks
Change from baseline in IGF-1 at 8 weeks.
Baseline and 8 weeks
Microbiota composition
Time Frame: Baseline and 8 weeks
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
Time Frame: Baseline and 8 weeks
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
Time Frame: Baseline and 8 weeks
Change from baseline in total cholesterol at 8 weeks of each phase.
Baseline and 8 weeks
LDL Cholesterol
Time Frame: Baseline and 8 weeks
Change from baseline in LDL cholesterol at 8 weeks of each phase.
Baseline and 8 weeks
HDL Cholesterol
Time Frame: Baseline and 8 weeks
Change from baseline in HDL cholesterol at 8 weeks of each phase.
Baseline and 8 weeks
Triglycerides
Time Frame: Baseline and 8 weeks
Change from baseline in triglycerides at 8 weeks of each phase.
Baseline and 8 weeks
Fasting glucose
Time Frame: Baseline and 8 weeks
Change from baseline in fasting glucose at 8 weeks of each phase.
Baseline and 8 weeks
Fasting insulin
Time Frame: Baseline and 8 weeks
Change from baseline in fasting insulin at 8 weeks of each phase.
Baseline and 8 weeks
Weight
Time Frame: Baseline and 8 weeks
Change from baseline in weight at 8 weeks of each phase.
Baseline and 8 weeks
Waist circumference
Time Frame: Baseline and 8 weeks
Change from baseline in weight at 8 weeks of each phase.
Baseline and 8 weeks
Blood pressure
Time Frame: Baseline and 8 weeks
Change from baseline in blood pressure at 8 weeks of each phase.
Baseline and 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with Plant Alternative products
Time Frame: Baseline and 8 weeks
Average satisfaction level with meals at 8 weeks of each phase (Meat phase compared to Plant Alternative phase) using a Likert scale.
Baseline and 8 weeks
Amount of Plant Alternative product consumption.
Time Frame: Baseline and 8 weeks
Average number of daily servings of traditional meat products in Meat phase compared to average number of daily servings of Plant Alternative products in Plant Alternative phase.
Baseline and 8 weeks
Gastrointestinal symptoms
Time Frame: Baseline and 8 weeks
Change from baseline in gastrointestinal symptoms, as assessed by the Gastrointestinal Symptoms Study Questionnaire at 8 weeks of each phase.
Baseline and 8 weeks
Perceived stress
Time Frame: Baseline and 8 weeks
Change from baseline in perceived stress, as assessed by the PSS-10 questionnaire at 8 weeks of each phase.
Baseline and 8 weeks
Perceived cognitive function
Time Frame: Baseline and 8 weeks
Change from baseline in perceived cognitive function, as assessed by the PROMIS SF v2.0 - Cognitive Function Abilities 4a and PROMIS SF v2.0 - Cognitive Function 4a questionnaires at 8 weeks of each phase.
Baseline and 8 weeks
Perceived fatigue
Time Frame: Baseline and 8 weeks
Change from baseline in perceived fatigue, as assessed by the PROMIS SF v1.0 - Fatigue-4a questionnaire at 8 weeks of each phase.
Baseline and 8 weeks
Perceived overall health
Time Frame: Baseline and 8 weeks
Change from baseline in perceived overall health, as assessed by the PROMIS Scale v1.2-Global Health questionnaire at 8 weeks of each phase.
Baseline and 8 weeks
Perceived well-being
Time Frame: Baseline and 8 weeks
Change from baseline in perceived well-being, as assessed by the WHO Well-Being Index questionnaire at 8 weeks of each phase.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher D. Gardner, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2018

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 48285

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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