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

December 3, 2024 updated by: Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hamilton Roschel, PhD
  • Phone Number: +55 11 3061-8789
  • Email: hars@usp.br

Study Locations

  • Brazil
      • São Paulo, Brazil, 05508-030
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
lean mass
Time Frame: DXA scans will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
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
Time Frame: Fiber cross sectional areas will be measured both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
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
Time Frame: 1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hamilton Roschel, Phd, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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