HealthyNCT03907059
Plant-based Dietary Protein and Resistance-training Adaptations
A study testing whey protein and soy protein in people with Healthy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. 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
- Healthy
- What is being tested?
- whey protein and soy protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Mar 2017to 19 Oct 2018
- 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
- Healthy young men
- Vegans ≥ 1 y or omnivorous subjects
- Physically active but no resistance-trained subjects
- Without any chronic injury that impairs resistance training performance
- Protein intake > 0.8 g/protein/kg body weight
Who cannot join
- Use of creatine or beta-alanine supplements for the last 3 months
- Use of proteins and/or amino acids supplements for the last 1 month
- Engagement in specific dietary restrictions
- Previous use of anabolic steroids
- Engagement in any training program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Exclusive Consumption of Plant-based Dietary Protein Impair Resistance Training-induced Muscle Adaptations?
Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. Leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence RT-induced gains in muscle mass and strength. In general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. In this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.
- Conditions
- Healthy
- Being tested
- whey protein, soy protein
- Keywords
- protein source, hypertrophy, resistance training, plant-based protein, omnivorous
- Medical subject headings
- Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whey proteinDietary supplement
supplementation individually adjusted to 1.6g/kg/day
soy proteinDietary supplement
supplementation individually adjusted to 1.6g/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Omnivorous | Active comparator | Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (whey) + 12 weeks of resistance training Receives: Dietary Supplement: whey protein |
| Vegan | Experimental | Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (soy) + 12 weeks of resistance training Receives: Dietary Supplement: soy protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle cross-sectional area
assessed by mode-B ultrasound
Measured: 12 weeks
Muscle strength
assessed by leg-press one-maximum-repetition
Measured: 12 weeks
Secondary outcomes (2)
Leg lean mass
assessed by Dual-energy X-ray absorptiometry
Measured: 12 weeks
fiber cross-sectional area
assessed by muscle biopsy (vastus lateralis)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start31 Mar 2017
- Primary completion16 Oct 2018
- Study completion19 Oct 2018
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Hamilton Roschel, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907059
- Sponsor's protocol ID
- 54014116.9.0000.5391
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18.
PubMed 33599941
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Exclusive Consumption of Plant-based Dietary Protein Impair Resistance Training-induced Muscle Adaptations?
- ClinicalTrials.gov ID
- NCT03907059
- Acronym / sponsor ID
- 54014116.9.0000.5391
- Conditions
- Healthy
- Keywords
- protein source, hypertrophy, resistance training, plant-based protein, omnivorous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 8 Apr 2019 (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.
Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. Leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence RT-induced gains in muscle mass and strength. In general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. In this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omnivorous | Active comparator | Dietary Supplement: whey proteinInterventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (whey) + 12 weeks of resistance training |
| Vegan | Experimental | Dietary Supplement: soy proteinInterventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (soy) + 12 weeks of resistance training |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy young men
- Vegans ≥ 1 y or omnivorous subjects
- Physically active but no resistance-trained subjects
- Without any chronic injury that impairs resistance training performance
- Protein intake > 0.8 g/protein/kg body weight
Key exclusion criteria (5 listed)
- Use of creatine or beta-alanine supplements for the last 3 months
- Use of proteins and/or amino acids supplements for the last 1 month
- Engagement in specific dietary restrictions
- Previous use of anabolic steroids
- Engagement in any training program
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 |
|---|---|---|
| whey proteinsupplementation individually adjusted to 1.6g/kg/day | Dietary supplement | Omnivorous |
| soy proteinsupplementation individually adjusted to 1.6g/kg/day | Dietary supplement | Vegan |
Primary outcome
Muscle cross-sectional area
Time frame: 12 weeks
assessed by mode-B ultrasound
Muscle strength
Time frame: 12 weeks
assessed by leg-press one-maximum-repetition
2 secondary outcomes
Leg lean mass
Time frame: 12 weeks
fiber cross-sectional area
Time frame: 12 weeks
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 9 Apr 2019.
- Derived from this study: PubMed 33599941Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18.
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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, Professor 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 whey protein and soy protein in people with Healthy, run by University of Sao Paulo 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 5 inclusion and 5 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 9 Apr 2019. 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?
Muscle cross-sectional area (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT03907059, 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 9 Apr 2019.