- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04648384
Acute Whey Protein And Casein Supplementation: Effect On Protein Metabolism After Resistance Exercise
November 30, 2020 updated by: Ellen Cristini de Freitas, University of Sao Paulo
Association of Whey Protein and Casein in the Same Proportions of Human Breast Milk Promoted Similar Branched-chain Amino Acids Profile and Reduced Delayed Muscle Soreness in Physically Active Man
The proteins of human breast milk are the most important endocrine signaling system that promotes neonatal growth by increasing the release of insulin, insulin-like growth factor-1 (IGF-1), and the leucine-mediated mammalian target of rapamycin complex 1- (mTORC1) signaling of pancreatic β-cells.
Remarkably, the branched-chain amino acids (BCAAs) leucine, isoleucine, and valine are involved in the growth-promoting effects of milk, protein biosynthesis, and metabolism because they physiologically stimulate insulin secretion The present study sought to investigate the effects of the combination of whey protein and casein in the ratio of 80:20 ("whey protein: casein" or "casein: whey protein") as breast milk proportion on the peak and the period of the permanence of branched-chain amino acids in the blood circulation, final metabolites of protein metabolism and delayed onset muscle soreness (DOMS) after a single bout of fasting or a resistance exercise session.
Study Overview
Status
Completed
Conditions
Detailed Description
The present study investigated the effects of the association of WP and casein in the ratio of 80:20, a similar ratio of human breast milk, on blood branched-chain amino acids (BCAAs) profile by HPLC technique, markers of protein metabolism (creatinine, urea, and urine nitrogen) and delayed onset muscle soreness (DOMS) after a single bout of resistance exercise.
A double-blind, crossover and acute study was conducted with ten men (age 29 ± 8 y; BMI: 25.4 ± 2.9 Kg/m2; 77 ± 12 kg; 1.74 ± 0.09 m) that were randomly assigned to five supplementation treatments: WP - whey protein; CAS - casein; WP/CAS - 80% WP/20% CAS; CAS/WP - 80% CAS/ 20% WP; PLA - placebo.
Participants were submitted to the following evaluations: performance sessions, blood collection for each session for the BCAAs profile determination, two food records, 3-days assessment of DOMS (24h, 48h, 72h) after each treatment.
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14049-900
- University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
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-
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
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy
- practice resistance training at least 3x a week
Exclusion Criteria:
- Smokers
- Muscle injures
- cardiovascular diseases
- Diabetes mellitus
- Lactose intolerance
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protein Supplementation and Resistance exercise
Protein supplementation composed of 20 gram of whey protein or casein in different proportions (80:20) and fasting state 10 sets of 10 reps at 85% of 1 Maximum repetition
|
Protein supplementation using 20 grams of whey protein or casein mix.
Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
Other Names:
10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise
|
|
Placebo Comparator: Placebo Supplementation
Placebo supplementation composed of 20 gram of Maltodextrin and fasting state 10 sets of 10 reps at 85% of 1 Maximum repetition
|
10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise
Placebo supplementation using 20 grams of Maltodextrin.
Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
Other Names:
|
|
Experimental: Resistance Training
Resistance Exercise will be performed before supplementation and is composed by 10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise.
|
10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in plasma amino acids concentration
Time Frame: 5 weeks
|
Blood sample collected for analysis of BCAA concentration after blend protein or placebo supplementation expressed in (µmol/L)
|
5 weeks
|
|
Change from baseline in 1RM test
Time Frame: 5 weeks
|
Change of training load using RPE, time and load expressed in (a.u)
|
5 weeks
|
|
Change in protein metabolism
Time Frame: 5 weeks
|
Change in nitrogen excretion, and nitrogen balance after protein supplementation expressed in (g/24 hours)
|
5 weeks
|
|
Changes from baseline in macronutrient intake
Time Frame: 5 weeks
|
Change of macronutrient intake were calculated pre and post treatment expressed in (g/24 hours)
|
5 weeks
|
|
Change in delayed onset muscle soreness
Time Frame: 5 weeks
|
Change from baseline the delayed onset muscle soreness pre, post, 24 hours, 48 hours and 72 hours after treatment expressed in (a.u)
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
March 20, 2016
Primary Completion (Actual)
July 20, 2019
Study Completion (Actual)
October 20, 2019
Study Registration Dates
First Submitted
November 9, 2020
First Submitted That Met QC Criteria
November 30, 2020
First Posted (Actual)
December 1, 2020
Study Record Updates
Last Update Posted (Actual)
December 2, 2020
Last Update Submitted That Met QC Criteria
November 30, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Protein Supplementation
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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