- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04213586
Effects of Whey Protein and Collagen Supplementation
January 28, 2020 updated by: Andreo Fernando Aguiar, Universidade Norte do Paraná
Effects of Whey Protein and Collagen Supplementation on Muscle Mass and Function During Training in Young Adults
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Paraná
-
Londrina, Paraná, Brazil, 86.041-140
- Universidade Norte do Paraná
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Whey Protein
Each participant will be supplemented with whey protein (7 d/wk) during 10 weeks.
|
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.
|
EXPERIMENTAL: Leucine-matched collagen
Each participant will be supplemented with collagen (7 d/wk) during 10 weeks.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in biceps brachii thickness
Time Frame: Baseline and after 10 weeks
|
Measured by ultrasonography pre- and post-training
|
Baseline and after 10 weeks
|
Change in muscle strength by training load
Time Frame: Baseline, 5 and 10 weeks
|
Training load for leg press, knee extension, and arm flexion exercises
|
Baseline, 5 and 10 weeks
|
Change in vertical jump
Time Frame: Baseline and after 10 weeks
|
Countermovement vertical jump performance will be assessed using the Smart Jump instrument
|
Baseline and after 10 weeks
|
Change in mean power
Time Frame: Baseline and after 10 weeks
|
Mean power using a isokinetic dynamometer (BIODEX)
|
Baseline and after 10 weeks
|
Change in peak torque
Time Frame: Baseline and after 10 weeks
|
Peak torque using a isokinetic dynamometer (BIODEX)
|
Baseline and after 10 weeks
|
Change in vastus lateralis thickness
Time Frame: Baseline and after 10 weeks
|
Measured by ultrasonography pre- and post-training
|
Baseline and after 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in testosterone-to-cortisol ratio
Time Frame: Baseline and after 10 weeks
|
Blood samples will be collected for analyse of the testosterone-to-cortisol ratio
|
Baseline and after 10 weeks
|
Dietary intake
Time Frame: Baseline, 2, 5, 10 weeks
|
Dietary intake to be assessed using 3-day diet recalls.
|
Baseline, 2, 5, 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andreo Aguiar, Universidade Norte do Paraná
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ACTUAL)
November 1, 2019
Study Completion (ACTUAL)
December 5, 2019
Study Registration Dates
First Submitted
December 11, 2019
First Submitted That Met QC Criteria
December 27, 2019
First Posted (ACTUAL)
December 30, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 30, 2020
Last Update Submitted That Met QC Criteria
January 28, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3.058.958
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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