NCT03907059

Brief Summary

Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. Leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence RT-induced gains in muscle mass and strength. In general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. In this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable healthy

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 31, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.5 years

First QC Date

April 5, 2019

Last Update Submit

April 5, 2019

Conditions

Healthy

Keywords

protein sourcehypertrophyresistance trainingplant-based proteinomnivorous

Outcome Measures

Primary Outcomes (2)

  • Muscle cross-sectional area

    assessed by mode-B ultrasound

    12 weeks

  • Muscle strength

    assessed by leg-press one-maximum-repetition

    12 weeks

Secondary Outcomes (2)

  • Leg lean mass

    12 weeks

  • fiber cross-sectional area

    12 weeks

Study Arms (2)

Omnivorous

ACTIVE COMPARATOR

Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (whey) + 12 weeks of resistance training

Dietary Supplement: whey protein

Vegan

EXPERIMENTAL

Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (soy) + 12 weeks of resistance training

Dietary Supplement: soy protein

Interventions

whey proteinDIETARY_SUPPLEMENT

supplementation individually adjusted to 1.6g/kg/day

Omnivorous
soy proteinDIETARY_SUPPLEMENT

supplementation individually adjusted to 1.6g/kg/day

Vegan

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men
  • Vegans ≥ 1 y or omnivorous subjects
  • Physically active but no resistance-trained subjects
  • Without any chronic injury that impairs resistance training performance
  • Protein intake \> 0.8 g/protein/kg body weight

You may not qualify if:

  • Use of creatine or beta-alanine supplements for the last 3 months
  • Use of proteins and/or amino acids supplements for the last 1 month
  • Engagement in specific dietary restrictions
  • Previous use of anabolic steroids
  • Engagement in any training program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

Related Publications (1)

  • Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18.

    PMID: 33599941DERIVED

MeSH Terms

Conditions

Hypertrophy

Interventions

Whey ProteinsSoybean Proteins

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPlant ProteinsPlant Proteins, DietarySoy FoodsVegetable ProductsVegetables

Study Officials

  • Hamilton Roschel, Professor

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 8, 2019

Study Start

March 31, 2017

Primary Completion

October 16, 2018

Study Completion

October 19, 2018

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

BR(1)