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

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 Overview

• Status: Recruiting
• Conditions: Diet Habit; Muscle Strength; Muscle, Skeletal; Resistance Training; Dietary Supplements
• Intervention / Treatment: Dietary supplement: Animal protein; Dietary supplement: Plant Protein

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hamilton Roschel, PhD; Phone Number: +55 11 3061-8789; Email: hars@usp.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05508-030
    • Recruiting
    • University of Sao Paulo
    • Contact: Hamilton Roschel, PhD; Phone Number: +55 11 3061-8789; Email: hars@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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-1. d-1

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: animal protein; Whey protein will be used as the active comparator for animal protein arm	Dietary supplement: Animal protein; 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.
Experimental: plant protein; A combination of pea and soy protein will be used as the experimental arm	Dietary supplement: Plant Protein; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
lean mass	total body and lower limb lean mass assessed by DXA	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	vastus lateralis fiber cross sectional area from muscle biopsy samples	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	lower-limb maximal isotonic strength will be assessed in the leg-press exercise by means of the one-repetition-maximum test (1-RM test)	1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA
• Investigators: Principal Investigator: Hamilton Roschel, PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 30, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 66029522.3.0000.0068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No