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MicrobiomeSWAP-MEATNCT03718988

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

A study testing Meat products and Plant Alternative products in people with Microbiome and Immune Function, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Meat products and Plant Alternative products
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
17 Jan 2019to 5 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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);
Show all 16Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Being tested
Meat products, Plant Alternative products
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meat productsBehavioural

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

  • Plant Alternative productsBehavioural

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

Study groups in NCT03718988
Study groupRoleWhat they receive
Meat Phase firstExperimentalParticipants will be asked to consume traditional meat products for 8 weeks, then switch to plant-based meat alternative products for another 8 weeks.
Receives: Behavioral: Meat products; Behavioral: Plant Alternative products
Plant Alternative Phase firstExperimentalParticipants will be asked to consume plant-based meat alternative products for 8 weeks, then switch to traditional meat products for another 8 weeks.
Receives: Behavioral: Meat products; Behavioral: Plant Alternative products

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Trimethylamine N-oxide (TMAO).

    Change from baseline in TMAO at 8 weeks.

    Measured: Baseline and 8 weeks

Secondary outcomes (12)

  1. Insulin-like Growth Factor-1 (IGF-1)

    Change from baseline in IGF-1 at 8 weeks.

    Measured: Baseline and 8 weeks

  2. 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.

    Measured: Baseline and 8 weeks

  3. 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.

    Measured: Baseline and 8 weeks

  4. Total Cholesterol

    Change from baseline in total cholesterol at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  5. LDL Cholesterol

    Change from baseline in LDL cholesterol at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  6. HDL Cholesterol

    Change from baseline in HDL cholesterol at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  7. Triglycerides

    Change from baseline in triglycerides at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  8. Fasting glucose

    Change from baseline in fasting glucose at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  9. Fasting insulin

    Change from baseline in fasting insulin at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  10. Weight

    Change from baseline in weight at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  11. Waist circumference

    Change from baseline in weight at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

  12. Blood pressure

    Change from baseline in blood pressure at 8 weeks of each phase.

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start17 Jan 2019
  3. Primary completion5 Dec 2019
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03718988
Sponsor's protocol ID
48285
Acronym
SWAP-MEAT
Status last verified
Feb 2023
First submitted
23 Oct 2018
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Crimarco A, Springfield S, Petlura C, Streaty T, Cunanan K, Lee J, Fielding-Singh P, Carter MM, Topf MA, Wastyk HC, Sonnenburg ED, Sonnenburg JL, Gardner CD. A randomized crossover trial on the effect of plant-based compared with animal-based meat on trimethylamine-N-oxide and cardiovascular disease risk factors in generally healthy adults: Study With Appetizing Plantfood-Meat Eating Alternative Trial (SWAP-MEAT). Am J Clin Nutr. 2020 Nov 11;112(5):1188-1199. doi: 10.1093/ajcn/nqaa203.

    PubMed 32780794

  • Ward CP, Landry MJ, Cunanan KM, Raphael KL, Dant CC, Gardner CD, Pao AC. Urinary Response to Consuming Plant-Based Meat Alternatives in Persons with Normal Kidney Function: The SWAP-MEAT Pilot Trial. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1417-1425. doi: 10.2215/CJN.0000000000000532. Epub 2024 Aug 26.

    PubMed 39514692

Questions about this trial

What is this clinical trial studying?

A study testing Meat products and Plant Alternative products in people with Microbiome and Immune Function, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Trimethylamine N-oxide (TMAO). (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03718988, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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