Health BehaviorNCT05472701
SWAP-MEAT Athlete: Three Diets on Athletic Performance
A study testing Diet order: WFPB, PBMA, Animal, WFPB, Animal, PBMA and PBMA, WFPB, Animal in people with Health Behavior, run by Stanford University at 1 site in United States.
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: WFPB, PBMA, Animal, WFPB, Animal, PBMA and PBMA, WFPB, Animal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 3 Oct 2021
- 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 12 week duration of the study.
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
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Health Behavior
- Being tested
- Diet order: WFPB, PBMA, Animal, WFPB, Animal, PBMA, PBMA, WFPB, Animal, PBMA, Animal, WFPB, Animal, WFPB, 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: WFPB, PBMA, AnimalBehavioural
Participants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each.
WFPB, Animal, PBMABehavioural
Participants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each.
PBMA, WFPB, AnimalBehavioural
Participants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each.
PBMA, Animal, WFPBBehavioural
Participants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each.
Animal, WFPB, PBMABehavioural
Participants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each.
Animal, PBMA, WFPBBehavioural
Participants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each.
| Study group | Role | What they receive |
|---|---|---|
| Whole Food Plant-Based (WFPB) | Experimental | 2 meals/day of traditional plant proteins (tofu, quinoa, black beans) and minimized intake of processed food, eggs, and dairy Receives: Behavioral: Diet order: WFPB, PBMA, Animal; Behavioral: WFPB, Animal, PBMA; Behavioral: PBMA, WFPB, Animal; Behavioral: PBMA, Animal, WFPB; Behavioral: Animal, WFPB, PBMA; Behavioral: Animal, PBMA, WFPB |
| Plant-Based Meat Alternatives (PBMA) | Experimental | 2 servings/day of plant-based meat alternatives (Beyond Beef, Impossible Burger, Gardein Chick'n) Receives: Behavioral: Diet order: WFPB, PBMA, Animal; Behavioral: WFPB, Animal, PBMA; Behavioral: PBMA, WFPB, Animal; Behavioral: PBMA, Animal, WFPB; Behavioral: Animal, WFPB, PBMA; Behavioral: Animal, PBMA, WFPB |
| Animal | Experimental | 2 servings/day of traditional meat products (beef burger, pork, chicken) Receives: Behavioral: Diet order: WFPB, PBMA, Animal; Behavioral: WFPB, Animal, PBMA; Behavioral: PBMA, WFPB, Animal; Behavioral: PBMA, Animal, WFPB; Behavioral: Animal, WFPB, PBMA; Behavioral: Animal, PBMA, WFPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, Week 8, Week 12
Composite Machine Strength Index (Resistance Trainers)
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
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (4)
Estimated VO2 max (Runners)
Change in VO2 max, estimated from training data compiled by Garmin Forerunner 235 after each diet phase
Measured: Baseline, Week 4, Week 8, Week 12
Maximum push-up and pull-up test
Change from baseline in maximum number of repetitions completed of push-up and pull-ups prior to exhaustion after each diet phase
Measured: Baseline, Week 4, Week 8, Week 12
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, Week 8, Week 12
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: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start26 Apr 2021
- Primary completion3 Oct 2021
- Study completion3 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 12 recreational runners and 12 recreational resistance trainers are assigned to one of six possible diet orders. Each diet order contains three phases for four weeks each-Animal, Plant-Based Meat Alternatives (PBMA), and Whole Food Plant-Based (WFPB)-in random order.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Gardner, Stanford University
- Investigators
- Christopher D Garnder, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472701
- Sponsor's protocol ID
- 59905
- Status last verified
- Feb 2023
- First submitted
- 21 Jul 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWAP-MEAT (Study With Appetizing Plant-Food, Meat Eating Alternatives Trial) Athlete
- ClinicalTrials.gov ID
- NCT05472701
- Acronym / sponsor ID
- 59905
- Conditions
- Health Behavior
- Keywords
- muscular strength, endurance, plant-based diets, meat alternatives, omnivore diets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 3 Oct 2021 (actual)
- Study completion
- 3 Oct 2021 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- SWAP-MEAT Athlete is a randomized crossover trial in which 12 recreational runners and 12 recreational resistance trainers are assigned to one of six possible diet orders. Each diet order contains three phases for four weeks each-Animal, Plant-Based Meat Alternatives (PBMA), and Whole Food Plant-Based (WFPB)-in random order.
| Arm | Type | Receives |
|---|---|---|
| Whole Food Plant-Based (WFPB) | Experimental | Behavioral: Diet order: WFPB, PBMA, Animal, Behavioral: WFPB, Animal, PBMA, Behavioral: PBMA, WFPB, Animal, Behavioral: PBMA, Animal, WFPB, Behavioral: Animal, WFPB, PBMA, Behavioral: Animal, PBMA, WFPB2 meals/day of traditional plant proteins (tofu, quinoa, black beans) and minimized intake of processed food, eggs, and dairy |
| Plant-Based Meat Alternatives (PBMA) | Experimental | Behavioral: Diet order: WFPB, PBMA, Animal, Behavioral: WFPB, Animal, PBMA, Behavioral: PBMA, WFPB, Animal, Behavioral: PBMA, Animal, WFPB, Behavioral: Animal, WFPB, PBMA, Behavioral: Animal, PBMA, WFPB2 servings/day of plant-based meat alternatives (Beyond Beef, Impossible Burger, Gardein Chick'n) |
| Animal | Experimental | Behavioral: Diet order: WFPB, PBMA, Animal, Behavioral: WFPB, Animal, PBMA, Behavioral: PBMA, WFPB, Animal, Behavioral: PBMA, Animal, WFPB, Behavioral: Animal, WFPB, PBMA, Behavioral: Animal, PBMA, WFPB2 servings/day of traditional meat products (beef burger, pork, chicken) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet order: WFPB, PBMA, AnimalParticipants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each. | Behavioural | Animal, Plant-Based Meat Alternatives (PBMA), Whole Food Plant-Based (WFPB) |
| WFPB, Animal, PBMAParticipants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each. | Behavioural | Animal, Plant-Based Meat Alternatives (PBMA), Whole Food Plant-Based (WFPB) |
| PBMA, WFPB, AnimalParticipants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each. | Behavioural | Animal, Plant-Based Meat Alternatives (PBMA), Whole Food Plant-Based (WFPB) |
| PBMA, Animal, WFPBParticipants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each. | Behavioural | Animal, Plant-Based Meat Alternatives (PBMA), Whole Food Plant-Based (WFPB) |
| Animal, WFPB, PBMAParticipants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each. | Behavioural | Animal, Plant-Based Meat Alternatives (PBMA), Whole Food Plant-Based (WFPB) |
| Animal, PBMA, WFPBParticipants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each. | Behavioural | Animal, Plant-Based Meat Alternatives (PBMA), Whole Food Plant-Based (WFPB) |
Primary outcome
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
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
4 secondary outcomes
Estimated VO2 max (Runners)
Time frame: Baseline, Week 4, Week 8, Week 12
Maximum push-up and pull-up test
Time frame: Baseline, Week 4, Week 8, Week 12
Dietary intake and adherence
Time frame: Baseline, Week 4, Week 8, Week 12
Diet satisfaction
Time frame: Week 4, Week 8, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 36384651Roberts 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.
- Study description and summary of resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Garnder, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet order: WFPB, PBMA, Animal, WFPB, Animal, PBMA and PBMA, WFPB, Animal in people with Health Behavior, 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 5 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 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?
Cooper 12-Minute Timed Run Test (Runners) (time frame: Baseline, Week 4, Week 8, Week 12). 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 NCT05472701, which also lists 1 linked publication.
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.