- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06014307
SWAP-MEAT With Athletes for MC-URC: Three Diets on Athletic Performance
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Robinson, PhD
- Phone Number: 650-736-8577
- Email: jlmorris@stanford.edu
Study Contact Backup
- Name: Abby Fammartino, MS, MSFS
- Phone Number: 503-896-6852
- Email: Abby.Fammartino@culinary.edu
Study Locations
-
-
Berkshire
-
Reading, Berkshire, United Kingdom, RG6 6AH
- Recruiting
- University of Reading
-
Contact:
- Charlotte Mills
- Email: c.e.mills@reading.ac.uk
-
-
-
-
California
-
Los Angeles, California, United States, 90095
- Not yet recruiting
- UCLA
-
Contact:
- Jenny Jay
- Email: jennyjay@ucla.edu
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University
-
Contact:
- Abby Fammartino, MS, MSFS
- Phone Number: 503-896-6852
- Email: Abby.Fammartino@culinary.edu
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers University
-
Contact:
- Peggy Policastro
- Email: peggyp@rutgers.edu
-
-
Tennessee
-
Nashville, Tennessee, United States, 37235
- Recruiting
- Vanderbilt University
-
Contact:
- Emily Svennevik
- Email: emily.svennevik@vanderbilt.edu
-
-
Texas
-
Denton, Texas, United States, 76205
- Not yet recruiting
- University of North Texas
-
Contact:
- Priscilla Connors
- Email: Priscilla.Connors@unt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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 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.
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
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Animal
2 servings/day of traditional meat products (beef burger, pork, chicken)
|
Participants will follow the PBMA, and Animal diets (in this order) for 4-6 weeks each.
Participants will follow the Animal, and PBMA diets (in this order) for 4-6 weeks each.
|
Experimental: Plant-Based Meat Alternatives (PBMA)
Up 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.
|
Participants will follow the PBMA, and Animal diets (in this order) for 4-6 weeks each.
Participants will follow the Animal, and PBMA diets (in this order) for 4-6 weeks each.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cooper 12-Minute Timed Run Test (Runners)
Time Frame: Baseline, Week 4 or Week 6
|
Change from baseline in distance covered on a 12-minute timed run after each diet phase
|
Baseline, Week 4 or Week 6
|
Composite Machine Strength Index (Resistance Trainers)
Time Frame: Baseline, Week 4 or Week 6
|
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
|
Baseline, Week 4 or Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dietary intake and adherence
Time Frame: Baseline, Week 4 or Week 6
|
Nutrient composition of each diet and adherence to diet in servings of protein source consumed per week, via weekly dietary logs.
|
Baseline, Week 4 or Week 6
|
Diet satisfaction
Time Frame: Baseline, Week 4 or Week 6
|
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.
|
Baseline, Week 4 or Week 6
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher D Gardner, PhD, Stanford University
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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