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Clinical Trials/NCT05710614
NCT05710614CompletedNot Applicable

Mixed Plant- vs. Animal-based Supplementary Protein to Support Muscle Adaptations to Resistance Exercise: a Randomized Clinical Trial

University of Sao Paulo General Hospital2 sites in 1 country40 target enrollmentStarted: August 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
vastus lateralis muscle cross sectional area

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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-

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

vastus lateralis muscle cross sectional area

Time Frame: Ultrasound images will be obtained both at baseline (before the comencement of the study) and immediately after the 12-week intervention period

the investigators used ultrasound measures of the vastus lateralis cross sectional area as the primary outcome

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hamilton Augusto Roschel da Silva

Doctor of Philosophy

University of Sao Paulo General Hospital

Study Sites (2)

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