Distinct Sources of Supplementary Protein in the Resistance Exercise Training-induced Adaptations
Mixed Plant- vs. Animal-based Supplementary Protein to Support Muscle Adaptations to Resistance Exercise: a Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
Brief Summary
This is a randomized controlled trial aimed to investigate the effects of different supplementary protein sources on muscle adaptations to resistance exercise. Young, healthy, recreationally active participants consuming an omnivorous diet with protein intake within recommended dietary allowance (RDA) (i.e.; 0.8-1.0 g.kg-1. d-1) will be recruited to undergo a 12-wk supervised resistance training program in combination with the intake of three 15-g daily doses (45g. d-1 total) of either a mixed plant- (i.e.; soy and pea protein) or animal-based (i.e.; whey protein) protein in drink form as a supplementary source of protein to their main meals of the day (i.e.; breakfast, lunch, and dinner). Before (PRE) and after (POST) the 12-wk intervention, participants will be assessed for body composition by dual-energy X-ray absorptiometry (DXA), muscle cross-sectional area (ultrasound) and fiber cross-sectional area (muscle biopsy), and maximal isotonic strength (1RM). Training consists of a resistance training (RT) program individually supervised by a researcher blinded to treatment in a laboratorial setting. Assessments will also be conducted in a blinded fashion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2024
CompletedDecember 6, 2024
December 1, 2024
1.3 years
January 20, 2023
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
vastus lateralis muscle cross sectional area
the investigators used ultrasound measures of the vastus lateralis cross sectional area as the primary outcome
Ultrasound images will be obtained both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
Secondary Outcomes (3)
lean mass
DXA scans will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
fiber cross sectional area
Fiber cross sectional areas will be measured both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
maximal isotonic strength
1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
Study Arms (2)
animal protein
ACTIVE COMPARATORWhey protein will be used as the active comparator for animal protein arm
plant protein
EXPERIMENTALA combination of pea and soy protein will be used as the experimental arm
Interventions
Patients allocated to this arm will be submitted a supervised resistance training program in combination with the intake of three 15-g daily doses (45g. d- 1 total) animal-based protein (i.e.; whey protein) in drink form as a supplementary source of protein in their main meals of the day.
Patients allocated to this arm will be submitted a supervised resistance training program in combination with the intake of three 15-g daily doses (45g. d- 1 total) mixed plant protein (i.e.; soy and pea) in drink form as a supplementary source of protein in their main meals of the day.
Eligibility Criteria
You may qualify if:
- Physically active (according to the International Physical Activity Questionnaire (IPAQ)
- Absence of any chronic condition that could preclude participation in a RT program or physical testing
- Habitual protein consumption within RDA ≥ 0.8 ≤1.0 g.kg-1. d-1
You may not qualify if:
- Prior history of anabolic steroids use, current or previous (≤ 3 m)
- Use of ergogenic or protein-based supplements, current or previous (\< 1 y)
- Engagement in energy-restricted diets
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
São Paulo, 05508-030, Brazil
Related Publications (1)
Santini MH, Erwig Leitao A, Mazzolani BC, Smaira FI, de Souza MSC, Santamaria A, Gualano B, Roschel H. Similar effects between animal-based and plant-based protein blend as complementary dietary protein on muscle adaptations to resistance training: findings from a randomized clinical trial. J Int Soc Sports Nutr. 2025 Dec;22(1):2568047. doi: 10.1080/15502783.2025.2568047. Epub 2025 Oct 8.
PMID: 41059835DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hamilton Roschel, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor of Philosophy
Study Record Dates
First Submitted
January 20, 2023
First Posted
February 2, 2023
Study Start
August 1, 2023
Primary Completion
November 27, 2024
Study Completion
November 27, 2024
Last Updated
December 6, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share