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

• Sponsor: University of Sao Paulo General Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05710614
• Collaborator: NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dietary Supplements; Muscle Strength; Muscle, Skeletal; Resistance Training; Diet Habit	Dietary Supplement: Animal protein; Dietary Supplement: Plant Protein	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mixed Plant- vs. Animal-based Supplementary Protein to Support Muscle Adaptations to Resistance Exercise: a Randomized Clinical Trial
• Anticipated Study Start Date: Feb 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: animal protein Whey protein will be used as the active comparator for animal protein arm	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.
Experimental: plant protein A combination of pea and soy protein will be used as the experimental arm	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

1. vastus lateralis muscle cross sectional area [the measure will be taken before and immediately after the intervention]

   the investigators used ultrasound measures of the vastus lateralis cross sectional area as the primary outcome

Secondary Outcome Measures

1. lean mass [the measure will be taken before and immediately after the intervention]

   total body and lower limb lean mass assessed by DXA

2. fiber cross sectional area [the measure will be taken before and immediately after the intervention]

   vastus lateralis fiber cross sectional area from muscle biopsy samples

3. maximal isotonic strength [the measure will be taken before and immediately after the intervention]

   upper and lower-limb maximal isotonic strength will be assessed in the bench- and leg-press exercises, respectively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Sao Paulo	São Paulo		Brazil	05508-030

Sponsors and Collaborators

• University of Sao Paulo General Hospital
• NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA

Investigators

• Principal Investigator: Hamilton Roschel, PhD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hamilton Augusto Roschel da Silva, Doctor of Philosophy, University of Sao Paulo General Hospital
• ClinicalTrials.gov Identifier: NCT05710614
• Other Study ID Numbers: 66029522.3.0000.0068
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 2, 2023