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

• Sponsor: Stanford University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06014307
• Collaborator: (none)
• Enrollment: 20
• Locations: 6
• Arms: 3
• Anticipated Duration (Months): 8
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Health Behavior	Behavioral: Diet order: WFPB, PBMA, Animal; Behavioral: Diet order: WFPB, Animal, PBMA; Behavioral: Diet order: PBMA, WFPB, Animal; Behavioral: Diet order: PBMA, Animal, WFPB; Behavioral: Diet order: Animal, WFPB, PBMA; Behavioral: Diet order: Animal, PBMA, WFPB	N/A

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 3x4-6 week randomized crossover trial that contains three arms: animal meat, plant-based alternative meat, and a whole food plant-based diet. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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.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 (Outcomes Assessor)
• Primary Purpose: Other
• 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
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 will follow the WFPB, PBMA, and Animal diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: WFPB, Animal, PBMA; Participants will follow the WFPB, Animal, and PBMA diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: PBMA, WFPB, Animal; Participants will follow the PBMA, WFPB, and Animal diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: PBMA, Animal, WFPB; Participants will follow the PBMA, Animal, and WFPB diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: Animal, WFPB, PBMA; Participants will follow the Animal, WFPB, and PBMA diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: Animal, PBMA, WFPB; Participants will follow the Animal, PBMA, and WFPB 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.	Behavioral: Diet order: WFPB, PBMA, Animal; Participants will follow the WFPB, PBMA, and Animal diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: WFPB, Animal, PBMA; Participants will follow the WFPB, Animal, and PBMA diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: PBMA, WFPB, Animal; Participants will follow the PBMA, WFPB, and Animal diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: PBMA, Animal, WFPB; Participants will follow the PBMA, Animal, and WFPB diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: Animal, WFPB, PBMA; Participants will follow the Animal, WFPB, and PBMA diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: Animal, PBMA, WFPB; Participants will follow the Animal, PBMA, and WFPB diets (in this order) for 4-6 weeks each.
Experimental: Animal 2 servings/day of traditional meat products (beef burger, pork, chicken)	Behavioral: Diet order: WFPB, PBMA, Animal; Participants will follow the WFPB, PBMA, and Animal diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: WFPB, Animal, PBMA; Participants will follow the WFPB, Animal, and PBMA diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: PBMA, WFPB, Animal; Participants will follow the PBMA, WFPB, and Animal diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: PBMA, Animal, WFPB; Participants will follow the PBMA, Animal, and WFPB diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: Animal, WFPB, PBMA; Participants will follow the Animal, WFPB, and PBMA diets (in this order) for 4-6 weeks each.; Behavioral: Diet order: Animal, PBMA, WFPB; Participants will follow the Animal, PBMA, and WFPB diets (in this order) for 4-6 weeks each.

Outcome Measures

Primary Outcome Measures

1. Cooper 12-Minute Timed Run Test (Runners) [Baseline, Week 4 or Week 6]

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

2. Composite Machine Strength Index (Resistance Trainers) [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

Secondary Outcome Measures

1. Dietary intake and adherence [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.

2. Diet satisfaction [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	Stanford University	Stanford	California	United States	94305
3	Rutgers University	New Brunswick	New Jersey	United States	08901
4	Vanderbilt University	Nashville	Tennessee	United States	37235
5	University of North Texas	Denton	Texas	United States	76205
6	University of Reading	Reading	Berkshire	United Kingdom	RG6 6AH

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Christopher D Gardner, PhD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Christopher Gardner, Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT06014307
• Other Study ID Numbers: 69487
• First Posted: Aug 28, 2023
• Last Update Posted: Aug 29, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Christopher Gardner, Principal Investigator, Stanford University: muscular strength; endurance; plant-based diets; meat alternatives; omnivore diets

Study Results

No Results Posted as of Aug 29, 2023