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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06014307
Other study ID # 69487
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2023
Est. completion date May 6, 2024

Study information

Verified date June 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date May 6, 2024
Est. primary completion date May 6, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom University of Reading Reading Berkshire
United States UCLA Los Angeles California
United States Vanderbilt University Nashville Tennessee
United States Rutgers University New Brunswick New Jersey
United States Stanford University Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cooper 12-Minute Timed Run Test (Runners) Change from baseline in distance covered on a 12-minute timed run after each diet phase Baseline, Week 4 or Week 6
Primary 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 Baseline, Week 4 or Week 6
Secondary 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. Baseline, Week 4 or Week 6
Secondary 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. Baseline, Week 4 or Week 6
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