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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04648384
Other study ID # Protein Supplementation
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2016
Est. completion date October 20, 2019

Study information

Verified date November 2020
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 20, 2019
Est. primary completion date July 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Healthy - practice resistance training at least 3x a week Exclusion Criteria: - Smokers - Muscle injures - cardiovascular diseases - Diabetes mellitus - Lactose intolerance

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Blend Protein Supplementation
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 Supplementation
Placebo supplementation using 20 grams of Maltodextrin. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
Other:
Resistance Exercise
10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise

Locations

Country Name City State
Brazil University of São Paulo, School of Physical Education and Sports of Ribeirão Preto. Ribeirão Preto São Paulo

Sponsors (4)

Lead Sponsor Collaborator
University of Sao Paulo Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 5 weeks
Primary Change from baseline in 1RM test Change of training load using RPE, time and load expressed in (a.u) 5 weeks
Primary Change in protein metabolism Change in nitrogen excretion, and nitrogen balance after protein supplementation expressed in (g/24 hours) 5 weeks
Primary Changes from baseline in macronutrient intake Change of macronutrient intake were calculated pre and post treatment expressed in (g/24 hours) 5 weeks
Primary 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) 5 weeks
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