Sports NutritionNCT04648384
Acute Whey Protein And Casein Supplementation: Effect On Protein Metabolism After Resistance Exercise
A study testing Blend Protein Supplementation and Resistance Exercise in people with Sports Nutrition and Protein Supplementation, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Nutrition, Protein Supplementation
- What is being tested?
- Blend Protein Supplementation and Resistance Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Mar 2016to 20 Oct 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- practice resistance training at least 3x a week
Who cannot join
- Smokers
- Muscle injures
- cardiovascular diseases
- Diabetes mellitus
- Lactose intolerance
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Sports Nutrition, Protein Supplementation
- Being tested
- Blend Protein Supplementation, Placebo Supplementation, Resistance Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blend Protein SupplementationDietary supplement
Also called Resistance Training
Protein supplementation using 20 grams of whey protein or casein mix. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
Placebo SupplementationDietary supplement
Also called Resistance Training
Placebo supplementation using 20 grams of Maltodextrin. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
Resistance ExerciseOther
10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise
| Study group | Role | What they receive |
|---|---|---|
| Protein Supplementation and Resistance exercise | Experimental | 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 Receives: Dietary Supplement: Blend Protein Supplementation; Other: Resistance Exercise |
| Placebo Supplementation | Placebo comparator | Placebo supplementation composed of 20 gram of Maltodextrin and fasting state 10 sets of 10 reps at 85% of 1 Maximum repetition Receives: Dietary Supplement: Placebo Supplementation; Other: Resistance Exercise |
| Resistance Training | Experimental | 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. Receives: Other: Resistance Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in plasma amino acids concentration
Blood sample collected for analysis of BCAA concentration after blend protein or placebo supplementation expressed in (µmol/L)
Measured: 5 weeks
Change from baseline in 1RM test
Change of training load using RPE, time and load expressed in (a.u)
Measured: 5 weeks
Change in protein metabolism
Change in nitrogen excretion, and nitrogen balance after protein supplementation expressed in (g/24 hours)
Measured: 5 weeks
Changes from baseline in macronutrient intake
Change of macronutrient intake were calculated pre and post treatment expressed in (g/24 hours)
Measured: 5 weeks
Change in delayed onset muscle soreness
Change from baseline the delayed onset muscle soreness pre, post, 24 hours, 48 hours and 72 hours after treatment expressed in (a.u)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start20 Mar 2016
- Primary completion20 Jul 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sports NutritionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648384
- Sponsor's protocol ID
- Protein Supplementation
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martinez Galan BS, Giolo De Carvalho F, Carvalho SCS, Cunha Brandao CF, Morhy Terrazas SI, Abud GF, Meirelles MSS, Sakagute S, Ueta Ortiz G, Marchini JS, Aristizabal JC, Cristini de Freitas E. Casein and Whey Protein in the Breast Milk Ratio: Could It Promote Protein Metabolism Enhancement in Physically Active Adults? Nutrients. 2021 Jun 23;13(7):2153. doi: 10.3390/nu13072153.
PubMed 34201617
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04648384
- Acronym / sponsor ID
- Protein Supplementation
- Conditions
- Sports Nutrition, Protein Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- 20 Mar 2016 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 1 Dec 2020 (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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Protein Supplementation and Resistance exercise | Experimental | Dietary Supplement: Blend Protein Supplementation, Other: Resistance ExerciseProtein 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 |
| Placebo Supplementation | Placebo comparator | Dietary Supplement: Placebo Supplementation, Other: Resistance ExercisePlacebo supplementation composed of 20 gram of Maltodextrin and fasting state 10 sets of 10 reps at 85% of 1 Maximum repetition |
| Resistance Training | Experimental | Other: Resistance ExerciseResistance 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy
- practice resistance training at least 3x a week
Key exclusion criteria (5 listed)
- Smokers
- Muscle injures
- cardiovascular diseases
- Diabetes mellitus
- Lactose intolerance
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 |
|---|---|---|
| Blend Protein SupplementationAlso: Resistance TrainingProtein supplementation using 20 grams of whey protein or casein mix. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition | Dietary supplement | Protein Supplementation and Resistance exercise |
| Placebo SupplementationAlso: Resistance TrainingPlacebo supplementation using 20 grams of Maltodextrin. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition | Dietary supplement | Placebo Supplementation |
| Resistance Exercise10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise | Other | Placebo Supplementation, Protein Supplementation and Resistance exercise, Resistance Training |
Primary outcome
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)
Change from baseline in 1RM test
Time frame: 5 weeks
Change of training load using RPE, time and load expressed in (a.u)
Change in protein metabolism
Time frame: 5 weeks
Change in nitrogen excretion, and nitrogen balance after protein supplementation expressed in (g/24 hours)
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)
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)
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 2 Dec 2020.
- Derived from this study: PubMed 34201617Martinez Galan BS, Giolo De Carvalho F, Carvalho SCS, Cunha Brandao CF, Morhy Terrazas SI, Abud GF, Meirelles MSS, Sakagute S, Ueta Ortiz G, Marchini JS, Aristizabal JC, Cristini de Freitas E. Casein and Whey Protein in the Breast Milk Ratio: Could It Promote Protein Metabolism Enhancement in Physically Active Adults? Nutrients. 2021 Jun 23;13(7):2153. doi: 10.3390/nu13072153.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blend Protein Supplementation and Resistance Exercise in people with Sports Nutrition and Protein Supplementation, run by University of Sao Paulo 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 2 Dec 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. Some participants in this study may receive a placebo. 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 from baseline in plasma amino acids concentration (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04648384, which also lists 1 linked publication.
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 2 Dec 2020.