NCT04648384

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

3.3 years

First QC Date

November 9, 2020

Last Update Submit

November 30, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • Change from baseline in 1RM test

    Change of training load using RPE, time and load expressed in (a.u)

    5 weeks

  • Change in protein metabolism

    Change in nitrogen excretion, and nitrogen balance after protein supplementation expressed in (g/24 hours)

    5 weeks

  • Changes from baseline in macronutrient intake

    Change of macronutrient intake were calculated pre and post treatment expressed in (g/24 hours)

    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)

    5 weeks

Study Arms (3)

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

Dietary Supplement: Blend Protein SupplementationOther: 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

Dietary Supplement: Placebo SupplementationOther: 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.

Other: Resistance Exercise

Interventions

Protein supplementation using 20 grams of whey protein or casein mix. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition

Also known as: Resistance Training
Protein Supplementation and Resistance exercise
Placebo SupplementationDIETARY_SUPPLEMENT

Placebo supplementation using 20 grams of Maltodextrin. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition

Also known as: Resistance Training
Placebo Supplementation

10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise

Placebo SupplementationProtein Supplementation and Resistance exerciseResistance Training

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • practice resistance training at least 3x a week

You may not qualify if:

  • Smokers
  • Muscle injures
  • cardiovascular diseases
  • Diabetes mellitus
  • Lactose intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 1, 2020

Study Start

March 20, 2016

Primary Completion

July 20, 2019

Study Completion

October 20, 2019

Last Updated

December 2, 2020

Record last verified: 2020-11

Locations