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Health BehaviorNCT06014307

SWAP-MEAT With Athletes for MC-URC: Three Diets on Athletic Performance

A study testing Diet order: PBMA, Animal and Diet order: Animal, PBMA in people with Health Behavior, run by Stanford University at 5 sites in 2 countries.

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 two plant-based diets-whole food plant-based (WFPB) and plant-based meat alternatives (PBMA)-vs. an omnivorous diet (Animal) on endurance and muscular strength in recreational athletes. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Health Behavior
What is being tested?
Diet order: PBMA, Animal and Diet order: Animal, PBMA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
5 sitesin 2 countries
Study dates
4 Oct 2023to 6 May 2024
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 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Generally healthy omnivorous adults between 18 and 35 years of age who report typically consuming at least 1 serving of meat per day and are willing to consume ~2 servings per day of animal meat, plant-based meat alternatives, and whole-food plant proteins.
  • Participants will have been consistent recreational runners or weightlifters (3-4 times per week) for at least the prior 1 year, and currently run or lift 3-4 times per week.
  • Runners will engage in at least 150 minutes of moderate-to-vigorous aerobic activity or 75 minutes of vigorous activity per week. All participants will have habitually consumed an omnivorous diet for at least months.
  • Participants will have self-reported good health and BMI 18.5-30.0.
  • Participants must be able to commit to running or resistance training at least 3-4 times per week for the duration of the study.
  • Participants will be on a Stanford meal plan which allows them access to the nine dining halls on the Stanford campus.

Who cannot join

  • Individuals who have participated in any restrictive diet within the last month, have any known nutrient intolerances, have orthopedic limitations, are participating in any other physical activity or diet study;
  • Individuals consuming any performance-enhancing drugs or medications known to interfere with athletic performance;
  • Individuals who have a chronic disease or eating disorder, are currently pregnant or intend to become pregnant in the next three months, or have an intent to compete in any physical activity competition within the next 3 months.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites
  • UCLA

    Los Angeles, California, 90095

  • Vanderbilt University

    Nashville, Tennessee, 37235

  • Rutgers University

    New Brunswick, New Jersey, 08901

  • Stanford University

    Stanford, California, 94305

Other trials in United States

United Kingdom1 site
  • University of Reading

    Reading, Berkshire, RG6 6AH

Other trials in United Kingdom

About this study

Official title: SWAP-MEAT (Study With Appetizing Plant-Food, Meat Eating Alternatives Trial) Athlete for MC-URC (Menus of Change University Research Collaborative): Three Diets on Athletic Performance

This study aims to investigate the impact of two plant-based diets-whole food plant-based (WFPB) and plant-based meat alternatives (PBMA)-vs. an omnivorous diet (Animal) on endurance and muscular strength in recreational athletes.

Read the detailed description

The SWAP-MEAT study compared the impact of consuming diets containing animal meat (primarily beef and pork) vs. plant-based alternative meats (Beyond Meat products) on health risk factors, cardiometabolic risk factors, and the gut microbiome in generally healthy adults. The SWAP-MEAT Athlete pilot study explored the impact of these diets on athletic performance instead of health biomarkers and cardiovascular disease.

The purpose of this study is to replicate the pilot study with the exception of using undergraduate students who have access to Stanford dining halls, rather than graduate students who have to buy and prepare their own food. It will be a 2x4-6 week randomized crossover trial that contains two arms: animal meat and plant-based alternative meat. Generally healthy recreational athletes will be recruited and complete athletic performance field tests at the end of each diet in order to assess athletic performance outcomes. From the SWAP-MEAT: Athlete pilot study, the investigators can attest to the feasibility of the trial and have justification for conducting this larger study.

This study will aim to focus on BIPOC (Black, Indigenous, People of Color) undergraduate students. By doing so, the investigators can gain a better understanding of the potential barriers and challenges to their adoption in diverse populations, for example, understanding of how cultural differences influence dietary choices and preconceptions about plant-based diets and animal protein alternatives. This study aims to address these limitations and provide valuable insights into the effectiveness of plant-based diets for recreational athletes, as well as potential barriers and challenges to their adoption in diverse populations.

Conditions
Health Behavior
Being tested
Diet order: PBMA, Animal, Diet order: Animal, PBMA
Keywords
muscular strength, endurance, plant-based diets, meat alternatives, omnivore diets
Medical subject headings
Health Behavior

What participants receive

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

  • Diet order: PBMA, AnimalBehavioural

    Participants will follow the PBMA, and Animal diets (in this order) for 4-6 weeks each.

  • Diet order: Animal, PBMABehavioural

    Participants will follow the Animal, and PBMA diets (in this order) for 4-6 weeks each.

Study groups in NCT06014307
Study groupRoleWhat they receive
Plant-Based Meat Alternatives (PBMA)ExperimentalUp to 2 servings per day of plant-based meat alternatives (Beyond Beef, Impossible Burger, Gardein Chick'n) OR as many plant-based meat alternative servings as available per day in the dining halls.
Receives: Behavioral: Diet order: PBMA, Animal; Behavioral: Diet order: Animal, PBMA
AnimalExperimental2 servings/day of traditional meat products (beef burger, pork, chicken)
Receives: Behavioral: Diet order: PBMA, Animal; Behavioral: Diet order: Animal, PBMA

What is being measured

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

  1. Cooper 12-Minute Timed Run Test (Runners)

    Change from baseline in distance covered on a 12-minute timed run after each diet phase

    Measured: Baseline, Week 4 or Week 6

  2. Composite Machine Strength Index (Resistance Trainers)

    Change from baseline in composite machine strength index (sum of 3-rep max chest press, leg press, biceps curls, and lat pull-down) after each diet phase

    Measured: Baseline, Week 4 or Week 6

Secondary outcomes (2)
  1. Dietary intake and adherence

    Nutrient composition of each diet and adherence to diet in servings of protein source consumed per week, via weekly dietary logs.

    Measured: Baseline, Week 4 or Week 6

  2. Diet satisfaction

    Score on Food Acceptability Questionnaire, measuring taste, appeal, and overall diet satisfaction, after each diet. We used the "Food Acceptability Questionnaire", with a minimum value of 1 and a maximum value of 7. A higher score indicates better food acceptability.

    Measured: Baseline, Week 4 or Week 6

Timeline

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

  1. First posted28 Aug 2023
  2. Study start4 Oct 2023
  3. Primary completion6 May 2024
  4. Study completion6 May 2024

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
SWAP-MEAT Athlete is a randomized crossover trial in which 10 recreational runners and 10 recreational resistance trainers are assigned to one of six possible diet orders. Each diet order contains three phases for 4 to 6 weeks each (4 weeks for universities on the quarter system; 6 weeks for universities on the semester system) -Animal, Plant-Based Meat Alternatives (PBMA), and Whole Food Plant-Based (WFPB)-in random order.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06014307
Sponsor's protocol ID
69487
Status last verified
Jun 2024
First submitted
23 Aug 2023
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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
  • Roberts AK, Busque V, Robinson JL, Landry MJ, Gardner CD. SWAP-MEAT Athlete (study with appetizing plant-food, meat eating alternatives trial) - investigating the impact of three different diets on recreational athletic performance: a randomized crossover trial. Nutr J. 2022 Nov 16;21(1):69. doi: 10.1186/s12937-022-00820-x.

    PubMed 36384651
  • Raygoza C, Roberts A, Guidetti A, Cai O, Sangowdar P, Muriuki EN, Laverick-Johnson H, Sanguinetti G, Smith E, Fammartino A, Robinson J, Lee E, Policastro P, Mills C, Kuhnle G, Svennevik E, Gardner C. Plant-Based vs. Omnivore diets for athletic performance outcomes among recreational athletes in university dining halls: a randomized crossover study. Nutr J. 2026 Feb 20;25(1):42. doi: 10.1186/s12937-026-01290-1.

    PubMed 41715155

Questions about this trial

What is this clinical trial studying?

A study testing Diet order: PBMA, Animal and Diet order: Animal, PBMA in people with Health Behavior, run by Stanford University at 5 sites in 2 countries.

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 6 inclusion and 3 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, United Kingdom. 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?

Cooper 12-Minute Timed Run Test (Runners) (time frame: Baseline, Week 4 or Week 6). The study lists 2 primary outcomes in all. 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 NCT06014307, which also lists 3 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 Jun 2024.

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