NCT05472701

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

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

July 21, 2022

Last Update Submit

February 18, 2023

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, 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

    Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (4)

  • Estimated VO2 max (Runners)

    Baseline, Week 4, Week 8, Week 12

  • Maximum push-up and pull-up test

    Baseline, Week 4, Week 8, Week 12

  • Dietary intake and adherence

    Baseline, Week 4, Week 8, Week 12

  • Diet satisfaction

    Week 4, Week 8, Week 12

Study Arms (3)

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

Behavioral: Diet order: WFPB, PBMA, AnimalBehavioral: WFPB, Animal, PBMABehavioral: PBMA, WFPB, AnimalBehavioral: PBMA, Animal, WFPBBehavioral: Animal, WFPB, PBMABehavioral: Animal, PBMA, WFPB

Plant-Based Meat Alternatives (PBMA)

EXPERIMENTAL

2 servings/day of plant-based meat alternatives (Beyond Beef, Impossible Burger, Gardein Chick'n)

Behavioral: Diet order: WFPB, PBMA, AnimalBehavioral: WFPB, Animal, PBMABehavioral: PBMA, WFPB, AnimalBehavioral: PBMA, Animal, WFPBBehavioral: Animal, WFPB, PBMABehavioral: Animal, PBMA, WFPB

Animal

EXPERIMENTAL

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

Behavioral: Diet order: WFPB, PBMA, AnimalBehavioral: WFPB, Animal, PBMABehavioral: PBMA, WFPB, AnimalBehavioral: PBMA, Animal, WFPBBehavioral: Animal, WFPB, PBMABehavioral: Animal, PBMA, WFPB

Interventions

Participants followed the WFPB, PBMA, and Animal diets (in this order) for 4 weeks each.

AnimalPlant-Based Meat Alternatives (PBMA)Whole Food Plant-Based (WFPB)

Participants followed the WFPB, Animal, and PBMA diets (in this order) for 4 weeks each.

AnimalPlant-Based Meat Alternatives (PBMA)Whole Food Plant-Based (WFPB)

Participants followed the PBMA, WFPB, and Animal diets (in this order) for 4 weeks each.

AnimalPlant-Based Meat Alternatives (PBMA)Whole Food Plant-Based (WFPB)

Participants followed the PBMA, Animal, and WFPB diets (in this order) for 4 weeks each.

AnimalPlant-Based Meat Alternatives (PBMA)Whole Food Plant-Based (WFPB)

Participants followed the Animal, WFPB, and PBMA diets (in this order) for 4 weeks each.

AnimalPlant-Based Meat Alternatives (PBMA)Whole Food Plant-Based (WFPB)

Participants followed the Animal, PBMA, and WFPB diets (in this order) for 4 weeks each.

AnimalPlant-Based Meat Alternatives (PBMA)Whole Food Plant-Based (WFPB)

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 12 week duration of the study.

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 (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • 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

Related Links

MeSH Terms

Conditions

Health Behavior

Interventions

polybutyl methacrylate

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christopher D Garnder, 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 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

April 26, 2021

Primary Completion

October 3, 2021

Study Completion

October 3, 2021

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations