NCT06014307

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 4, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

August 23, 2023

Last Update Submit

June 19, 2024

Conditions

Keywords

muscular strengthenduranceplant-based dietsmeat alternativesomnivore diets

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Dietary intake and adherence

    Baseline, Week 4 or Week 6

  • Diet satisfaction

    Baseline, Week 4 or Week 6

Study Arms (2)

Plant-Based Meat Alternatives (PBMA)

EXPERIMENTAL

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: PBMA, AnimalBehavioral: Diet order: Animal, PBMA

Animal

EXPERIMENTAL

2 servings/day of traditional meat products (beef burger, pork, chicken)

Behavioral: Diet order: PBMA, AnimalBehavioral: Diet order: Animal, PBMA

Interventions

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

AnimalPlant-Based Meat Alternatives (PBMA)

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

AnimalPlant-Based Meat Alternatives (PBMA)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UCLA

Los Angeles, California, 90095, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

University of Reading

Reading, Berkshire, RG6 6AH, United Kingdom

Location

Related 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.

    PMID: 32780794BACKGROUND
  • 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.

    PMID: 36384651BACKGROUND

MeSH Terms

Conditions

Health Behavior

Interventions

polybutyl methacrylate

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christopher D Gardner, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 28, 2023

Study Start

October 4, 2023

Primary Completion

May 6, 2024

Study Completion

May 6, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations