Distinct Sources of Supplementary Protein in the Resistance Exercise Training-induced Adaptations

Diet Habit Clinical Trial

Official title:

Mixed Plant- vs. Animal-based Supplementary Protein to Support Muscle Adaptations to Resistance Exercise: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710614
• Other study ID #: 66029522.3.0000.0068
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diet Habit
• Dietary Supplements
• Muscle Strength
• Muscle, Skeletal
• Resistance Training

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