Clinical trial NCT05710614: Distinct Sources of Supplementary Protein in the Resistance Exercise Training-induced Adaptations
Official title: Mixed Plant- vs. Animal-based Supplementary Protein to Support Muscle Adaptations to Resistance Exercise: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplements
Muscle Strength
Muscle, Skeletal
Resistance Training
Diet Habit
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA
First posted: 2023-02-02
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: vastus lateralis muscle cross sectional area
timeFrame: Ultrasound images will be obtained both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
Secondary outcomes:
measure: lean mass
timeFrame: DXA scans will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
measure: fiber cross sectional area
timeFrame: Fiber cross sectional areas will be measured both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
measure: maximal isotonic strength
timeFrame: 1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Hamilton Roschel, PhD
role: PRINCIPAL_INVESTIGATOR
References: