ExerciseNCT04213586
Effects of Whey Protein and Collagen Supplementation
A study testing Whey protein supplementation and Collagen supplementation in people with Exercise and Nutrition Therapy, run by Universidade Norte do Paraná at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Nutrition Therapy, Resistance Training
- What is being tested?
- Whey protein supplementation and Collagen supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 5 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18-35 years
- To be eutrophic (not overweight or obese)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise, Nutrition Therapy, Resistance Training, Muscle Strength, Hypertrophy
- Being tested
- Whey protein supplementation, Collagen supplementation
- Keywords
- Protein supplementation, Amino acids, Resistance exercise, Muscle strength, Muscle hypertrophy
- Medical subject headings
- Motor Activity, Hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementationDietary supplement
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein | Experimental | Each participant will be supplemented with whey protein (7 d/wk) during 10 weeks. Receives: Dietary Supplement: Whey protein supplementation |
| Leucine-matched collagen | Experimental | Each participant will be supplemented with collagen (7 d/wk) during 10 weeks. Receives: Dietary Supplement: Collagen supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biceps brachii thickness
Measured by ultrasonography pre- and post-training
Measured: Baseline and after 10 weeks
Change in muscle strength by training load
Training load for leg press, knee extension, and arm flexion exercises
Measured: Baseline, 5 and 10 weeks
Change in vertical jump
Countermovement vertical jump performance will be assessed using the Smart Jump instrument
Measured: Baseline and after 10 weeks
Change in mean power
Mean power using a isokinetic dynamometer (BIODEX)
Measured: Baseline and after 10 weeks
Change in peak torque
Peak torque using a isokinetic dynamometer (BIODEX)
Measured: Baseline and after 10 weeks
Change in vastus lateralis thickness
Measured by ultrasonography pre- and post-training
Measured: Baseline and after 10 weeks
Secondary outcomes (2)
Change in testosterone-to-cortisol ratio
Blood samples will be collected for analyse of the testosterone-to-cortisol ratio
Measured: Baseline and after 10 weeks
Dietary intake
Dietary intake to be assessed using 3-day diet recalls.
Measured: Baseline, 2, 5, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start1 Sep 2019
- Primary completion1 Nov 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Principal investigator, Andreo Fernando Aguiar, Universidade Norte do Paraná
- Investigators
- Andreo Aguiar, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213586
- Sponsor's protocol ID
- 3.058.958
- Status last verified
- Jan 2020
- First submitted
- 11 Dec 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whey Protein and Collagen Supplementation on Muscle Mass and Function During Training in Young Adults
- ClinicalTrials.gov ID
- NCT04213586
- Acronym / sponsor ID
- 3.058.958
- Conditions
- Exercise, Nutrition Therapy, Resistance Training, Muscle Strength, Hypertrophy
- Keywords
- Protein supplementation, Amino acids, Resistance exercise, Muscle strength, Muscle hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein | Experimental | Dietary Supplement: Whey protein supplementationEach participant will be supplemented with whey protein (7 d/wk) during 10 weeks. |
| Leucine-matched collagen | Experimental | Dietary Supplement: Collagen supplementationEach participant will be supplemented with collagen (7 d/wk) during 10 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women aged 18-35 years
- To be eutrophic (not overweight or obese)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementation35 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. | Dietary supplement | Whey Protein |
| Collagen supplementation35 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. | Dietary supplement | Leucine-matched collagen |
Primary outcome
Change in biceps brachii thickness
Time frame: Baseline and after 10 weeks
Measured by ultrasonography pre- and post-training
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
Change in vertical jump
Time frame: Baseline and after 10 weeks
Countermovement vertical jump performance will be assessed using the Smart Jump instrument
Change in mean power
Time frame: Baseline and after 10 weeks
Mean power using a isokinetic dynamometer (BIODEX)
Change in peak torque
Time frame: Baseline and after 10 weeks
Peak torque using a isokinetic dynamometer (BIODEX)
Change in vastus lateralis thickness
Time frame: Baseline and after 10 weeks
Measured by ultrasonography pre- and post-training
2 secondary outcomes
Change in testosterone-to-cortisol ratio
Time frame: Baseline and after 10 weeks
Dietary intake
Time frame: Baseline, 2, 5, 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreo Aguiar principal investigator
Universidade Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplementation and Collagen supplementation in people with Exercise and Nutrition Therapy, run by Universidade Norte do Paraná at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in biceps brachii thickness (time frame: Baseline and after 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.