NCT06733857

Brief Summary

Among the general population, it has been established that plant-based diets confer significant environmental benefits (greenhouse gas emissions, land use, and water use) compared to omnivorous diets. However, sports nutrition recommendations for supporting resistance exercise-induced gains in muscle mass and strength differ substantially from population-level recommendations, especially for protein intake. Therefore the difference in environmental impact between omnivorous and plant-based diets for adults following such recommendations is as yet unknown. A prior analysis found that a high-protein, non-animal-derived diet can support resistance training-induced gains in muscle mass and strength to the same extent as a protein-matched omnivorous diet. These findings align with previous research showing that, in the context of a high-protein diet, the source of protein - whether animal or plant-based - does not affect the rate of resistance exercise-induced gains in muscle mass and strength. The present study therefore plans to retrospectively analyze the diet records from previously published research to determine the difference in environmental impact between the high protein animal-free and omnivorous diets. The findings could highlight the unique difference in environmental impacts between those following high protein plant-based and omnivorous diets.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Typical duration 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

May 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

December 4, 2024

Last Update Submit

December 10, 2024

Conditions

Keywords

Life cycle assessmentEnvironmental impactPlant-basedProtein sourceHypertrophySustainability

Outcome Measures

Primary Outcomes (3)

  • Diet-related greenhouse gas emissions - CO2 equivalents

    Diet-related greenhouse gas emissions defined as CO2 equivalents resulting from food production, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.

    Applied to diet records for the duration of the 10-week intervention

  • Diet-related land use - hectares

    Diet-related land use defined as agricultural land required for food production and measured in hectares, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.

    Applied to diet records for the duration of the 10-week intervention

  • Diet-related water use - cubic meters

    Diet-related water use defined as freshwater required for food production and measured in cubic meters, calculated by applying environmental life cycle assessments of individual foods and food categories to dietary records.

    Applied to diet records for the duration of the 10-week intervention

Study Arms (2)

Plant-based

EXPERIMENTAL

Participants were to consume a high protein plant-based diet while completing a 10-week exercise program consisting of 5 exercise sessions per week.

Behavioral: VEG2

Omnivorous

ACTIVE COMPARATOR

Participants were to consume a high protein omnivorous diet while completing a 10-week exercise program consisting of 5 exercise sessions per week.

Behavioral: OMNI2

Interventions

VEG2BEHAVIORAL

Participants were provided with a caloric target to place them in a ∼0 to 10% energy surplus, and a protein target of 2 g·kg bm-1·d-1. Participants were instructed to avoid animal products for ≥6 d per wk, focusing their intake on protein-rich non-animal-derived foods (for example, mycoprotein-containing products, pulses, soy). To facilitate reaching protein intake targets, the research team provided participants with mycoprotein-containing vegan products (∼1-2 products per day) to be used as the main protein source for some meals. This group also received 105-g mycoprotein (46-g protein, 10-g carbohydrate, 13-g fat, 348 kcal), 35-g post-training, and 70-g before bed.

Plant-based
OMNI2BEHAVIORAL

Participants were provided with a caloric target to place them in a ∼0 to 10% energy surplus, and a protein target of 2 g·kg bm-1·d-1. Participants in OMNI2 were instructed to consume an omnivorous diet, focusing their intake on high-quality animal-derived proteins (that is, meat, milk, yogurt, cheese). To facilitate reaching protein intake targets, the research team provided participants with a weekly supply (∼1-2 products per day) of chicken or beef to be used as the main protein source for some meals. This group also received 59-g supplemental milk protein daily (47-g protein, 2-g carbohydrate, \<1-g fat, 198 kcal) 19.5-g to drink post-training and 39-g to drink before sleep.

Omnivorous

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females 18 - 40 years of age.
  • Body mass index between 18 and 30.
  • Recreationally active.
  • Resistance training experienced (have previous performed resistance exercise, and are familiar with the basic movements).

You may not qualify if:

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
  • Any diagnosed cardiovascular disease or hypertension (to avoid any complications associated with heavy exercise).
  • Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
  • Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
  • A personal or family history of epilepsy, seizures or schizophrenia.
  • Allergic to mycoprotein / Quorn, penicillin, or milk.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Game Changers Institute

Laguna Niguel, California, 92677, United States

Location

Related Publications (1)

  • Monteyne AJ, Coelho MOC, Murton AJ, Abdelrahman DR, Blackwell JR, Koscien CP, Knapp KM, Fulford J, Finnigan TJA, Dirks ML, Stephens FB, Wall BT. Vegan and Omnivorous High Protein Diets Support Comparable Daily Myofibrillar Protein Synthesis Rates and Skeletal Muscle Hypertrophy in Young Adults. J Nutr. 2023 Jun;153(6):1680-1695. doi: 10.1016/j.tjnut.2023.02.023. Epub 2023 Feb 22.

    PMID: 36822394BACKGROUND

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 13, 2024

Study Start

May 1, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

A spreadsheet with full food diary entries (redacted) which the environmental analyses will be based on.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 3 months and ending 3 years after the publication of results
Access Criteria
On request, research institutions will be emailed a protected spreadsheet with full food diary entries (redacted) which the environmental analyses will be based on, as well as the study protocol and the statistical analysis plan.

Locations