- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03907059
Plant-based Dietary Protein and Resistance-training Adaptations
April 5, 2019 updated by: Bruno Gualano, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
38
Phase
- 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 Locations
-
-
SP
-
Sao Paulo, SP, 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
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Omnivorous
Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (whey) + 12 weeks of resistance training
|
supplementation individually adjusted to 1.6g/kg/day
|
EXPERIMENTAL: Vegan
Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (soy) + 12 weeks of resistance training
|
supplementation individually adjusted to 1.6g/kg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle cross-sectional area
Time Frame: 12 weeks
|
assessed by mode-B ultrasound
|
12 weeks
|
Muscle strength
Time Frame: 12 weeks
|
assessed by leg-press one-maximum-repetition
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Leg lean mass
Time Frame: 12 weeks
|
assessed by Dual-energy X-ray absorptiometry
|
12 weeks
|
fiber cross-sectional area
Time Frame: 12 weeks
|
assessed by muscle biopsy (vastus lateralis)
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hamilton Roschel, Professor, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
March 31, 2017
Primary Completion (ACTUAL)
October 16, 2018
Study Completion (ACTUAL)
October 19, 2018
Study Registration Dates
First Submitted
April 5, 2019
First Submitted That Met QC Criteria
April 5, 2019
First Posted (ACTUAL)
April 8, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 9, 2019
Last Update Submitted That Met QC Criteria
April 5, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 54014116.9.0000.5391
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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