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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04213586
Other study ID # 3.058.958
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 5, 2019

Study information

Verified date January 2020
Source Universidade Norte do Paraná
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this study will be to investigate the effects of whey protein vs. leucine-matched collagen supplementation on muscle mass and function after a 10-wk resistance training program. Initially, all participants will be submitted for a 2-wk familiarization period, and then randomized into two groups (N = 11 / group): whey protein group and leucine-matched collagen group. The following variables will be assessed from pre-to post-training: anthropometric, muscle thickness from vastus lateralis and biceps brachii muscles using ultrasound, training load, mean power and peak torque for unilateral arm flexion exercise using a isokinetic dynamometer, countermovement vertical jump, nutritional intake, and testosterone-to-cortisol ratio . Shapiro-Wilk and Levine tests will be used to test the normality and homogeneity of the measurements, respectively. Two-way ANOVA (group x time) tests for repeated measures will be performed to assess changes over time and between groups for all dependent variables. Violation of sphericity will adjust using Greenhouse- Geyser correction. The Bonferroni post-hoc test will detect specific differences between groups. When appropriate, the percentage of change (∆%) will be reported according to the following equation: ∆% = [(pre-average post average) / pre-average mean] × 100. Values will be express as mean ± standard deviation. O significance level α will be 0.05.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date December 5, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Men and women aged 18-35 years

- To be eutrophic (not overweight or obese)

Exclusion Criteria:

- 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.

Study Design


Intervention

Dietary Supplement:
Whey protein supplementation
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.
Collagen supplementation
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.

Locations

Country Name City State
Brazil Universidade Norte do Paraná Londrina Paraná

Sponsors (2)

Lead Sponsor Collaborator
Universidade Norte do Paraná Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in biceps brachii thickness Measured by ultrasonography pre- and post-training Baseline and after 10 weeks
Primary Change in muscle strength by training load Training load for leg press, knee extension, and arm flexion exercises Baseline, 5 and 10 weeks
Primary Change in vertical jump Countermovement vertical jump performance will be assessed using the Smart Jump instrument Baseline and after 10 weeks
Primary Change in mean power Mean power using a isokinetic dynamometer (BIODEX) Baseline and after 10 weeks
Primary Change in peak torque Peak torque using a isokinetic dynamometer (BIODEX) Baseline and after 10 weeks
Primary Change in vastus lateralis thickness Measured by ultrasonography pre- and post-training Baseline and after 10 weeks
Secondary Change in testosterone-to-cortisol ratio Blood samples will be collected for analyse of the testosterone-to-cortisol ratio Baseline and after 10 weeks
Secondary Dietary intake Dietary intake to be assessed using 3-day diet recalls. Baseline, 2, 5, 10 weeks
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