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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05710614
Other study ID # 66029522.3.0000.0068
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date March 1, 2025

Study information

Verified date November 2023
Source University of Sao Paulo General Hospital
Contact Hamilton Roschel, PhD
Phone +55 11 3061-8789
Email hars@usp.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Brazil University of Sao Paulo São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary vastus lateralis muscle cross sectional area 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 lean mass 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
Secondary fiber cross sectional area 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
Secondary 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) 1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period
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