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Completed

NCT Number: NCT05710614

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

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.

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Key information

Conditions

Dietary Supplements Behavior Behavior, Animal Diet Habit Feeding Behavior Muscle Strength Muscle, Skeletal Resistance Training

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05508-030, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animal protein

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. vastus lateralis muscle cross sectional area

    Time frame: Ultrasound images will be obtained both at baseline (before the comencement of the study) and immediately after the 12-week intervention period

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

Secondary outcomes

  1. lean mass

    Time frame: DXA scans will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period

    total body and lower limb lean mass assessed by DXA

  2. fiber cross sectional area

    Time frame: Fiber cross sectional areas will be measured both at baseline (before the comencement of the study) and immediately after the 12-week intervention period

    vastus lateralis fiber cross sectional area from muscle biopsy samples

  3. maximal isotonic strength

    Time frame: 1-RM tests will be taken both at baseline (before the comencement of the study) and immediately after the 12-week intervention period

    lower-limb maximal isotonic strength will be assessed in the leg-press exercise by means of the one-repetition-maximum test (1-RM test)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • NotCo Brasil Distribuicao e Comercio de Produtos Alimenticios LTDA

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2023
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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