NCT05710614

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

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

First Submitted

Initial submission to the registry

January 20, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2024

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.3 years

First QC Date

January 20, 2023

Last Update Submit

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 COMPARATOR

Whey protein will be used as the active comparator for animal protein arm

Dietary Supplement: Animal protein

plant protein

EXPERIMENTAL

A combination of pea and soy protein will be used as the experimental arm

Dietary Supplement: Plant Protein

Interventions

Animal proteinDIETARY_SUPPLEMENT

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.

animal protein
Plant ProteinDIETARY_SUPPLEMENT

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.

plant protein

Eligibility Criteria

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

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

Location

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.

MeSH Terms

Conditions

Feeding Behavior

Interventions

Plant Proteins

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Hamilton Roschel, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

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

Locations