SWAP-MEAT Athlete: Three Diets on Athletic Performance

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

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

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.

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 diets are environmentally sustainable and beneficial for cardiovascular health, but athletes are often concerned that these diets do not contain enough protein to support athletic performance. However, few randomized trials investigating the effect of plant-based vs. omnivorous diets on athletic performance have been conducted. Within this randomized crossover trial, recreational runners and resistance trainers will be assigned to three diets for four weeks each (WFPB, PBMA, and Animal). PMBA is an emerging, modern type of plant-based diet for which the impact on athletic performance has not yet been assessed. Participants will complete athletic fields at baseline and after each diet, and athletic performance on diets and study feasibility in this cohort of recreational athletes will be assessed. The study design was inspired by the original SWAP-MEAT study that investigated cardiovascular risk factors in adults consuming 8-week omnivorous and plant-based meat alternative diets (Crimarco, 2020).

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.
24

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 to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 12 week duration of the study.

Exclusion Criteria:

  • 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.

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

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: Whole Food Plant-Based (WFPB)
2 meals/day of traditional plant proteins (tofu, quinoa, black beans) and minimized intake of processed food, eggs, and dairy
Behavioral: Diet order: WFPB, PBMA, Animal
Participants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each.
Behavioral: WFPB, Animal, PBMA
Participants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each.
Behavioral: PBMA, WFPB, Animal
Participants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each.
Behavioral: PBMA, Animal, WFPB
Participants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each.
Behavioral: Animal, WFPB, PBMA
Participants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each.
Behavioral: Animal, PBMA, WFPB
Participants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each.
Experimental: Plant-Based Meat Alternatives (PBMA)
2 servings/day of plant-based meat alternatives (Beyond Beef, Impossible Burger, Gardein Chick'n)
Behavioral: Diet order: WFPB, PBMA, Animal
Participants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each.
Behavioral: WFPB, Animal, PBMA
Participants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each.
Behavioral: PBMA, WFPB, Animal
Participants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each.
Behavioral: PBMA, Animal, WFPB
Participants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each.
Behavioral: Animal, WFPB, PBMA
Participants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each.
Behavioral: Animal, PBMA, WFPB
Participants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each.
Experimental: Animal
2 servings/day of traditional meat products (beef burger, pork, chicken)
Behavioral: Diet order: WFPB, PBMA, Animal
Participants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each.
Behavioral: WFPB, Animal, PBMA
Participants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each.
Behavioral: PBMA, WFPB, Animal
Participants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each.
Behavioral: PBMA, Animal, WFPB
Participants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each.
Behavioral: Animal, WFPB, PBMA
Participants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each.
Behavioral: Animal, PBMA, WFPB
Participants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each.

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
Cooper 12-Minute Timed Run Test (Runners)
Time Frame: Baseline, Week 4, Week 8, Week 12
Change from baseline in distance covered on a 12-minute timed run after each diet phase
Baseline, Week 4, Week 8, Week 12
Composite Machine Strength Index (Resistance Trainers)
Time Frame: Baseline, Week 4, Week 8, Week 12
Change from baseline in composite machine strength index (sum of 3-rep max chest press, leg press, and lat pull-down) after each diet phase
Baseline, Week 4, Week 8, Week 12

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
Estimated VO2 max (Runners)
Time Frame: Baseline, Week 4, Week 8, Week 12
Change in VO2 max, estimated from training data compiled by Garmin Forerunner 235 after each diet phase
Baseline, Week 4, Week 8, Week 12
Maximum push-up and pull-up test
Time Frame: Baseline, Week 4, Week 8, Week 12
Change from baseline in maximum number of repetitions completed of push-up and pull-ups prior to exhaustion after each diet phase
Baseline, Week 4, Week 8, Week 12
Dietary intake and adherence
Time Frame: Baseline, Week 4, Week 8, Week 12
a. Nutrient composition of each diet and adherence to diet in servings of protein source consumed per week, via weekly dietary logs
Baseline, Week 4, Week 8, Week 12
Diet satisfaction
Time Frame: Week 4, Week 8, Week 12
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.
Week 4, Week 8, Week 12

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

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.
April 26, 2021

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.
October 3, 2021

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.
October 3, 2021

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).
July 21, 2022

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.
July 21, 2022

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.
July 25, 2022

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

Keywords

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.
  • 59905

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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