NCT04213586

Brief Summary

The present project aims to investigate the effects of high-quality protein (whey protein) vs. low-quality protein (collagen) on muscle mass and function (e.g., strength and power) during a 10-wk resistance training program in young adults. It will be tested the hypothesis that leucine-matched collagen should promote similar gains on muscle function and mass compared to whey protein supplementation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2 months

First QC Date

December 11, 2019

Last Update Submit

January 28, 2020

Conditions

Keywords

Protein supplementationAmino acidsResistance exerciseMuscle strengthMuscle hypertrophy

Outcome Measures

Primary Outcomes (6)

  • Change in biceps brachii thickness

    Measured by ultrasonography pre- and post-training

    Baseline and after 10 weeks

  • Change in muscle strength by training load

    Training load for leg press, knee extension, and arm flexion exercises

    Baseline, 5 and 10 weeks

  • Change in vertical jump

    Countermovement vertical jump performance will be assessed using the Smart Jump instrument

    Baseline and after 10 weeks

  • Change in mean power

    Mean power using a isokinetic dynamometer (BIODEX)

    Baseline and after 10 weeks

  • Change in peak torque

    Peak torque using a isokinetic dynamometer (BIODEX)

    Baseline and after 10 weeks

  • Change in vastus lateralis thickness

    Measured by ultrasonography pre- and post-training

    Baseline and after 10 weeks

Secondary Outcomes (2)

  • Change in testosterone-to-cortisol ratio

    Baseline and after 10 weeks

  • Dietary intake

    Baseline, 2, 5, 10 weeks

Study Arms (2)

Whey Protein

EXPERIMENTAL

Each participant will be supplemented with whey protein (7 d/wk) during 10 weeks.

Dietary Supplement: Whey protein supplementation

Leucine-matched collagen

EXPERIMENTAL

Each participant will be supplemented with collagen (7 d/wk) during 10 weeks.

Dietary Supplement: Collagen supplementation

Interventions

35 g of whey protein (7 d/wk) during a 10-wk resistance training program (3 d/wk; 3 sets of 8-12 repetitions with an interval of 1-2 minutes between sets and exercises) involving the leg press, leg extension, and arm flexion exercises. The load will be adjusted weekly.

Whey Protein
Collagen supplementationDIETARY_SUPPLEMENT

35 g of collagen (7 d/wk) + 2 g of leucine during a 10-wk resistance training program (3 d/wk; 3 sets of 8-12 repetitions with an interval of 1-2 minutes between sets and exercises) involving the leg press, leg extension, and arm flexion exercises. The load will be adjusted weekly.

Leucine-matched collagen

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women aged 18-35 years
  • To be eutrophic (not overweight or obese)

You may not qualify if:

  • To present a history of musculoskeletal disorders
  • Be attending a systematized weight training program for at least six months
  • To make use of medicines that could affect muscle function.
  • To have used ergogenic supplements and anabolic steroids for at least six months before study
  • To have restrictions for exercises practice considering Physical Activity Readiness Questionnaire (PAR-Q) responses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Norte do Paraná

Londrina, Paraná, 86.041-140, Brazil

Location

MeSH Terms

Conditions

Motor ActivityHypertrophy

Condition Hierarchy (Ancestors)

BehaviorPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Andreo Aguiar

    Universidade Norte do Paraná

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 30, 2019

Study Start

September 1, 2019

Primary Completion

November 1, 2019

Study Completion

December 5, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations