Dietary SupplementsNCT05710614
Distinct Sources of Supplementary Protein in the Resistance Exercise Training-induced Adaptations
A study testing Animal protein and Plant Protein in people with Dietary Supplements and Muscle Strength, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements, Muscle Strength, Muscle, Skeletal
- What is being tested?
- Animal protein and Plant Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2023to 27 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Animal protein, Plant Protein
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| animal protein | Active comparator | Whey protein will be used as the active comparator for animal protein arm Receives: Dietary Supplement: Animal protein |
| plant protein | Experimental | A combination of pea and soy protein will be used as the experimental arm Receives: Dietary Supplement: Plant Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
vastus lateralis muscle cross sectional area
the investigators used ultrasound measures of the vastus lateralis cross sectional area as the primary outcome
Measured: 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
total body and lower limb lean mass assessed by DXA
Measured: 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
Measured: 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)
Measured: 1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Aug 2023
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA
- Responsible party
- Principal investigator, Hamilton Augusto Roschel da Silva, University of Sao Paulo General Hospital
- Investigators
- Hamilton Roschel, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710614
- Sponsor's protocol ID
- 66029522.3.0000.0068
- Status last verified
- Dec 2024
- First submitted
- 20 Jan 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41059835
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Plant- vs. Animal-based Supplementary Protein to Support Muscle Adaptations to Resistance Exercise: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05710614
- Acronym / sponsor ID
- 66029522.3.0000.0068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| animal protein | Active comparator | Dietary Supplement: Animal proteinWhey protein will be used as the active comparator for animal protein arm |
| plant protein | Experimental | Dietary Supplement: Plant ProteinA combination of pea and soy protein will be used as the experimental arm |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal proteinPatients 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. | Dietary supplement | animal protein |
| Plant ProteinPatients 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. | Dietary supplement | plant protein |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Derived from this study: PubMed 41059835Santini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamilton Roschel, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal protein and Plant Protein in people with Dietary Supplements and Muscle Strength, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05710614, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.