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Distinct Sources of Supplementary Protein in the Resistance Exercise Training-induced Adaptations

NCT ID: NCT05710614

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-11-27

Brief Summary

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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.

Detailed Description

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Conditions

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Dietary Supplements Muscle Strength Muscle, Skeletal Resistance Training Diet Habit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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animal protein

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

Group Type ACTIVE_COMPARATOR

Animal protein

Intervention Type DIETARY_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.

plant protein

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

Group Type EXPERIMENTAL

Plant Protein

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hamilton Augusto Roschel da Silva

Doctor of Philosophy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamilton Roschel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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University of Sao Paulo

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 41059835 (View on PubMed)

Other Identifiers

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66029522.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id